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Migrating to cloud based erp solution
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Migration from On-Premise to Cloud based ERP System
Migration from On-Premise to Cloud based ERP System 700 500 Xcelpros Team

Introduction

If you are dealing with a legacy ERP system that is slowing down your business productivity or limits your ability to grow, its time to start planning the changeover to a new system. Moreover, if you are struggling to get a grip over the exceeding maintenance cost, it’s no longer an option then, rather an absolute must have to upgrade your legacy system to a cloud-based ERP. Upgrading an ERP system is a critical business decision and involves in-depth research and planning. A scalable cloud-based ERP solution capable of managing a comprehensive set of business functions is what you need.

76%

of enterprises have a formal cloud strategy and 74% of organizations will increase cloud spending to over 20% by 2020.

Source: Per a prediction by Forrester and IDC

2020 has come and gone, with higher cloud adoption than expected. Many companies were struggling to adjust to the new normal with their archaic tools. Companies that transformed prior to the pandemic found it comparatively simpler to work remotely and still keep productivity up, in some cases productivity of a company has gone higher than expected due to remote work. If you take a look at the marketplace of today’s business, it’s a data-driven environment. Any decisions business leaders take based on numbers and insights to get the best results.

If you are operating on legacy systems, your business landscape is not up-to-date to provide real-time analytics or meet a modern business’s requirements. To enable a data-driven organization, you need to revamp your system.

The result is innumerable complexities in business operations such as gaps due to handling multiple databases, duplicate manual data entry, broken data flow between departments, missed deadlines, etc. On-premise ERP systems require a series of hardware updates that make the total cost of ownership (TCO) even higher. Security concerns, regulatory compliance, policy necessities add to the complexities.

60%or more companies still use outdated ERP systems, per Microsoft survey.

59% of respondents expressed they will prefer an upgrade to cloud-based ERP in their next implementation, per the Microsoft survey.

80%of organizations are allocating budget for cloud projects. However, more than half are burdened with legacy systems and lack in-house expertise, per IBM

The journey from ERP 1.0 to ERP 2.0

The evolution of ERP happened over a long period of time. It has taken organizations decades to reach the current shape of ERP. The root of modern ERP lies in older production management models like EOQ (economic order quantity) and MRP (materials requirements planning). After years of relying on old inventory management procedures, the manufacturing industry gets its upgrade, MRP II, a software solution enabling computing power to manage different business aspects. Further scrutinizing the broadened scope of MRP II, Gartner coins the term ERP. Later addressing the key market shifts, Gartner calls the software ERP II, a solution capable of tracking real-time, web-based data.

Microsoft Dynamics 365 offers Tier 2 ERP solution that offers superior functionality in minimum complexities and cost. It makes the upgrade and integration easier to the latest technologies and provides a transformative experience.

A switch from ERP 1.0 to 2.0 opens innovation areas by increasing your current IT landscape’s flexibility. Also, cloud migrated mainframes produce an approximate 47 percent lower cost of operations spread across five years than on-premise mainframe platforms.

A popular Cisco survey in 2017 showed that 83% of the best performing US businesses planned an effective SaaS strategy and have started collaborating with cloud vendors. Cisco’s Global Cloud Index for the period 2013-2018 showed that 59% of all cloud workflows would be delivered as SaaS by the end of the year. Moreover, Infrastructure-as-a-service (IaaS) will decline to 28% compared to 44% in 2013, and that only 13% of workloads will be delivered as Platform-as-a-Service(PaaS).

A survey report of Harvard Business Review Analytic Services reveals that 36% of 560 marketing professionals reported legacy systems to be one of the biggest roadblocks in implementing real-time analytics.

Legacy systems may offer you a high horsepower and set customer experiences, but upgrading to new software to keep up with the technological and generational growth is essential for ensuring better performance.

Regardless of the advantages of staying in your comfort zone and managing business processes with your legacy ERP system, these factors drive you to switch from legacy to cloud –

1.Operational inefficiencies:When your business expands, migrating to the cloud is an effective solution to keep track of all the real-time data and increase collaboration across your company’s different departments. Clinging to legacy software during business expansion decreases benefits of cloud ERP systems.

2.Growth of business:Growth of a firm often refers to the global expansion, reporting and compliance requirements and expansion of financial services. New opportunities like market growth, acquisitions and disinvestments require stabilized systems with smooth processes to be in place. As mentioned above, streamlining various departmental functions that deal with them for development and growth requires an agile cloud-based platform.

3.Technological Transformation:Unlike the expectations from previously used legacy systems, today’s users demand collaboration and ease. Companies expect essential operational functions like real-time analytics with customized dashboards, social collaboration with increased mobile access, and quick updates. This is easily achieved using cloud ERP systems.

Legacy to Cloud – Data migration challenges

Many companies operate on home-grown legacy systems, comprising both hardware and software. These systems were the foundation of working business systems and managers might hesitate to switch to other alternatives without a transformation plan. Though it is tough to make ERP implementation decisions, every business needs to upgrade to stay ahead of competitors. Some of the fears are also related to Data migration.

Per a report by Bloor Research, 31% of cloud data migration projects fail. Following are a few hurdles faced by organizations today, resulting in migration failure.

  • Insufficient knowledge of source data – A knowledge gap leads to problems such as lack of source knowledge, duplicates, missing information and erroneous data. This gives users a false perspective of data in the new system resulting in an incorrect design. Bad data leads to problems, and companies blame the new system until they figure out what the real issue is. It is essential to understand what information is a business need vs. a system constraint. Such situations make it essential for you to understand the source of data.
  • Unstructured processes – The process of data migration involves disparate technologies used by disparate people. Manual data migration increases human errors resulting in inaccurate, incomplete and outdated information. The outcome of such errors is the lack of technologies and resources to correct data. It is essential to perform an advanced analysis while planning and designing to help you recover these hidden errors.
  • Failure in implementation validation – Ineffective testing during the initial stage of deployment and lack of knowledge about the data sources results in its implementation failures. Running a few tests using the full volume of the data helps estimate the worst-case scenario missed using conveniently available data.
  • Late final result evaluation – This issue usually occurs at the testing stage, where users see only the final data compiled into the system at the end of design and development. Problems like data incompatibility with the new ERP system arise at this stage, which can be avoided with effective testing during the migration process saving the company time, money and delayed data migration time. Users can get involved in the evolving test cases to show them data output’s actual prototypes.
  • Lack of full usage of expertise – Most companies do not use the right expertise. They face issues in decoding large codes, obtaining access to these codes and other functional challenges. Introducing such experts to your project helps make sense of the disparate data for effective data migration techniques.

Figure: 1Benefits of moving ERP to the cloud

Benefits of moving ERP to the cloud

The bigger question – What does the cloud have to offer?

Even though migrating to the cloud might look like a hefty expense, it saves you from the troubles of operational inefficiency, effective demand forecasting, poor customer service and reduced ROI.

A few characteristics and advantages of a new and advanced cloud-based ERP would be –

  • Improved ERP Performance – The switch from on-premise to the cloud helps free up computational power and resources that are essentially necessary while deploying an effective ERP solution. This is one of the most significant advantages offered by the cloud, which eliminates any infrastructural costs, helping smaller businesses flourish and the only necessity is a well-established internet system.Microsoft Azure offers you a flexible cloud platform that quickly adapts to your business’s needs and requirements. It is simple to adjust and provides a host of building blocks that allow you to customize the cloud according to yourself.
  • Reduced Operational Costs – An on-premise ERP software requires a workforce to maintain it. The additional costs on human resources and the ERP software cost can increase operational costs for the firm. Using cloud ERP software gives you benefits like a monthly subscription tailored to the customer’s needs at a low outlay cost. As the implementation costs are much lower, the overall operational costs also reduce.
    The cloud’s added benefit is that it provides a common platform for developing various solutions, negating the developing time for constructing programs from scratch. The aforementioned helps in the allocation of resources for other activities that add a higher business value.Due to its large customer base, Microsoft offers a large volume of discounts to their customers. Azure usually works as a pay-as-you-go model, reducing the input costs for smaller companies. Larger enterprises who sign contracts are offered a more considerable discount as well.
  • Higher Security – The input and output of the ERP systems’ data is generally confidential and requires a well-established and secure maintenance system. Cloud ERP offers superior quality security systems that ensure that the information is effectively protected and encrypted. The user access to such data helps in the effective correction in the areas needed.Microsoft Azure offers you a multi-layered security system helping you detect threats earlier with unique intelligence.
  • Real-Time Analytics – Contemporary software-based solutions make it necessary for industry models to offer real-time data for the process optimization and business intelligence based on which decisions can be made. Cloud ERP software comprises API links to the platform, helping users scale reporting and analytical needs. The instant access to the data on the cloud makes information readily available, which benefits industries like manufacturing, where real-time data tracking helps in process optimization.
  • Enhanced UAT and API testing – An effective User Acceptance Testing and API beta testing has become a more common approach. In opposition to testing in isolation in an engineering setting, UAT and API methodology are more conducive to finding and more responsive to real-world problems.

Figure: 2 Variety of functions offered on the cloud

Variety of functions offered on the cloud

Cloud for ROI

The two main components of calculating ROI for an ERP software are –

  • required investment and savings
  • efficiencies & goodwill

The calculation of ROI for the software does not have a predetermined methodology as the software brings a variety of intangible values with itself. The benefits are primarily in reducing operation cost, optimizing inventory levels, labor cost and improved production.

The ROI is often masked in reductions of operational costs of running the company using transparency in the organization and the activities taking place in it. The benefits can also be reduced administrative costs by reduced paperwork and time information exchange using real-time data tracking. Inventory costs are reduced by optimizing material stock and by tracking the inventory health in turn increasing the ROI of the software.

Azure is the only major cloud platform ranked by Gartner as an industry leader for both infrastructure-as-a-service (IaaS) and platform-as-a-service (PaaS).

What does Azure have to offer to you?

As per a Forbes study, enterprise adoption of Microsoft Azure increased significantly from 43% to 58% in 2018, attaining a 35% CAGR.

Raising cloud ERP adoption rates by such a high margin shows the increasing popularity of the software gained from features like increasing flexibility. Azure adopts and adapts other operating systems’ standards and embraces competing for software platforms to ensure it stays relevant to as many people and companies as possible.

Here are a few advantages of Azure –

  • Widespread customer support as Microsoft spreads over 19 regions across the globe and offers support plans in a variety of languages.
  • Offers a hybrid environment that helps you gain benefits from both on-premise and cloud software solutions without any added cost burdens.
  • Visual studio online and application insights helping in developer collaboration and increased options.
  • Offers you virtual systems like Linux and Windows servers, increasing your ability to run virtual machines.
  • Ability to scale on demand
  • Reliable back-ups in case of data loss
  • “Set it and forget it” scheduling
  • Increased automation
  • Reliable data storage and increased security

Figure: 3Cloud benefits to your business

Cloud benefits to your business

Key Takeaways

  • In most organizations, legacy systems are still hovering around because the cost of refurbishing them is too high till they are in working condition and the management sees this as business overhead. On the other hand, the IT department sees it as a can of worms. Due to reeling communication, responsibility and financial problems, the organization are unwilling and initiate this migration.
  • The best thing the organizations can do in such a case is to hire an external vendor or an SME who can assess the situation and make this difficult decision and formulate a pragmatic approach to convince the stakeholders else they will pay for the opportunity cost of losing.
  • Finally, we can’t undermine having a proper cloud alliance that can help the organizations lift-and-shift their legacy systems to the cloud and reinvent these systems’ performance and makes all stakeholders see ERP cloud migration’s long-term gains.

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Artificial Intelligence in Sales Performance
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How Artificial Intelligence Helps in Boosting Sales Performance
How Artificial Intelligence Helps in Boosting Sales Performance 700 500 Xcelpros Team

At a Glance

  • In today’s hyper-connected digital world, customers expect personalization, convenience, and targeted sales experiences. Sales professionals are continuously striving to provide an enhanced and integrated customer experience.
  • Sales Professionals face many challenges every day – a better understanding of buyers’ needs, value communication, demand prediction and most importantly, staying connected with the customer.
  • Low customer engagement hinders companies’ brand image, forcing them to switch to other brands that better cater to customer requirements. Availability of market data and customer behavior is driving sales professionals to understand customer needs better. Enhanced customer experience ensures business outcomes.
  • Sales powered by Artificial Intelligence is the differentiator that can build better customer relationships as AI helps to understand customer behavior, enhances your ability to forecast, and enables you to focus on sales that matter. AI in sales also helps you in effective demand forecasting to stay in line with the market demands.

The Age of Distraction

Your sales departments play a pivotal role in your organization. They face numerous challenges in increasing customer satisfaction. The significant consequence of living in a digital era is that sales reps get defocussed as they cannot accurately read the customer information. Sellers need appropriate tools to instill a focused effort on sales.

These distractions reduce sales efficiencies by 14%

59%Sales people claim to have too many tools

64% Sales reps’ time is spent on non-selling activities

50%Sales reps’ have no idea about what is expected of them

In addition to distractions, sellers face increasing complexity in today’s sales environment. They work with an average of 10 stakeholders for every purchase decision to be made, resulting in buying decisions to take 97%¹ (Gartner) longer than expected.

Yet, 60% of companies lack a well-defined sales process, further contributing to the long sales cycles. The need to work with different functions and people requires more collaboration, adding to its complexity.

Using Artificial intelligence in sales helps you streamline your sales process by automating various functions like – sales execution, tracking sales performance, connecting with prospects helping you increase your conversion and win rates.

For instance, AI automation in sales has helped automate purchasing using bots decreasing 15 to 20% of expenditure sourced through e-platforms.

Gartner predicts that 30% of all B2B companies will employ some type of AI to augment at least one of their primary sales processes by 2020. Your competitors are experimenting with artificial intelligence, looking at the benefits it offers from automating their sales processes. Per McKinsey, companies using artificial intelligence in sales have seen –

  • 50% increase in leads and appointments
  • 40-60% decrease in overall costs
  • 60-70% decrease in call time

While staying at par with competition makes automation a must, clarifying the software’s personalized capabilities and limitations is paramount.

85%

of customers will manage their relationships with different enterprises using bots or virtual assistants by 2020.

Source: Gartner

Smart CRM Solutions Can

  • Transform decision-making across many functional areas
  • Unite key functional areas on organizational goals
  • Improve efficiency, accuracy, profitability
  • Allow staffers to do more creative & strategic work

How can AI help your sales department?

There remains a misconception that AI automation can replace humans. Instead, AI helps humans to increase accuracy and perform their jobs better than before. Incorporating artificial intelligence in your sales departments enables you to automate various tasks done by humans and reduces the scope for human error increasing efficiency. Your sales department can benefit from AI by –

AI for increased price optimization: To decide the discount to be given to a client is always a tricky question for companies. As important as winning the deal is, leaving money on the table is a loss for you. Adopting artificial intelligence in sales departments helps you estimate the ideal discount rate for a proposal by viewing the specific features of a past deal closed. These features also include Features could include: the size of the deal in dollars, product specification compliance, number of competitors, company size, territory/region, client’s industry, client’s annual revenues, a public or private company, and level of decision-makers (influencers) involved.

AI for Better Forecasting: Forbes estimates that 74% of large B2B firms engage in sales forecasting every week. They also estimate that 69% of companies, regardless of their size, consider their sales forecasting methods to be ineffective. Sales managers face a daunting challenge in tracking where their team’s total revenue falls short each revenue cycle. Using AI in sales can help you effectively estimate and predict your revenue, reducing your operational challenges to manage your inventory and resources better.

Companies boasting accurate sales forecasts are 10% more likely to grow their revenue and 7% more likely to meet their targets.Source: Aberdeen Group

Cross-selling and up-selling: The most effective and economical way to increase profits is to sell more to your existing client base. But how do you understand which audience to target? You can spend your revenue marketing your product to the wrong audience or use AI algorithms to identify which clients would be willing to update their product (up-selling) and/or buy a completely different product that you offer (cross-selling).

Enhanced lead scoring: 61% of companies say misleading buying signals are a huge barrier to effective lead scoring. They claim to fall prey to customers’ gut impulses and inaccurate information, which significantly hurts their lead scoring or bottom line. Per Forbes, 68% of respondents reported implementing lead scoring strategies, whereas 40% believe in the value associated with lead scoring.

Effective performance management: Sales managers are expected to eagerly track their team performance and look out for barriers in meeting their revenue targets. With AI, they can now use dashboards that showcase employee performance and help managers predict which salespeople are likely to hit their quotas and which deals have a higher chance of being closed.

Empowering your sales force with AI technology

Before investing in a pilot project, you need to meet your sales managers and understand the potential use cases to determine the suited requirement. Three types of AI technology promises results for B2B sales organizations. They are –

  • AI in Sales Predictions – Analytics like AI in sales forecasting find correlations between various data points. Such tools automatically create the insights that are essential to managers and sales reps. For example, they can determine a prospect’s likelihood to become your client and help in sales forecasting.
  • Prescriptive – Such analytics supports guided selling. AI suggests activities based on all the sales methodologies adopted by the firm. This is a step forward to move a deal to the next sales stage or develop a pricing model based on a prospect’s general preferences.
  • AI for Text and sentiment analysis with Natural Language Processing – understands and analyzes the context of customers’ questions and their behavior. Using sentiment analysis, sales reps are alerted if signs of dissatisfaction are discovered.

What Microsoft Dynamics has to offer: Exclusive Features

Dynamics 365 AI for Sales enables salespeople to build stronger functional relationships with their customers to increase customer satisfaction. It helps them take actions based on helpful insights helping them close sales faster.

Dynamics 365 AI for Sales offers the following capabilities for sellers:

  • Relationship analytics: This feature helps you assemble relevant information from the entire database to create a graphical representation of all the KPIs and activity histories. Such a visual display showcases KPIs and activity histories for any contact, opportunity, lead or account.
  • Predictive lead scoring: This feature helps you generate scores for all your leads in the pipeline. It assigns a score between 0 to 100 to leads based on signals from them and related entities such as contact and account. This helps you identify and prioritize leads with more chances of converting into opportunities.
  • Predictive opportunity scoring: This feature provides a scoring model to generate scores for opportunities in your pipeline. It assigns a score between 0 and 100 to all the opportunities based on the signals they give out and other related entities such as contact and account. This helps identify and prioritize opportunities that have more chances of converting into sales.
  • Notes analysis: Notes give you intelligent suggestions to help you save time and effort by taking actions such as creating a meeting request and adding a contact. The text in the note is highlighted and when selected, suggestions are displayed.
  • Talking points: This feature is useful to help you start conversations with customers based on emails. The conservation starters include topics that are related to Health, sports, vacation, family, and entertainment. These topics help you start a conversation with your customer, as you can choose your customer’s area of interest. Talking points will display only the latest communication for each topic in hand.
  • Who knows whom: This feature provides you details such as your contact’s name and email address who knows the lead. Using these details, you can reach out to your contact and get introduced to a lead and increase the chances of a positive outcome during the interaction.

Key Takeaways

  • Good sales professionals advance their sales processes by leveraging the right skills at the right time. They become agile in their approach to numerous stakeholders who represent a host of opinions and interests.
  • Sales managers will require their workforce to have skills and tools to help customers build the case for change by understanding how factors like desired outcomes and solution options influence decisions.
  • Companies can benefit from seeing tangible rep to customer conversion analytics and identify different ways to improve deal closure rate.

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CRM in Pharmaceutical Industry
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How CRM Fosters Customer Engagement in the Pharmaceutical Industry
How CRM Fosters Customer Engagement in the Pharmaceutical Industry 700 500 Xcelpros Team

At a Glance

  • Pharmaceutical Companies are updating their software systems to improve customer retention, customer satisfaction and increase up-selling products.
  • By the end of 2018, the Customer Relationship Management (CRM) system became the most extensive and fastest-growing software market globally, estimated to churn out $80 billion revenue by 2025.
  • The primary reason for the staggering growth of the CRM software industry is the accessibility to customer data that help businesses close customer deals.
  • The pharmaceutical industry’s complexity makes CRM software a must for faster development to retain and expand its existing customer base.

Post COVID19, most sales and marketing teams have gone remote. The unforeseen circumstances of not having an in-person interaction with customers have driven businesses to invest in the latest and conversion-oriented CRM tools. Pharmaceutical Companies are rapidly onboarding systems for marketing, sales, and customer service. Companies now have newer sales objectives such as managing long-distance interactions, maintaining the same engagement with health care providers, pharmacies and even end patients. Tools need to be interactive, AI-based and understand customer behavior based on their interactions to meet the mentioned sales objectives. We have seen an increase in polls and surveys, more digital content like videos, podcasts. And more impetus on tracking each of these interactions’ results. There is a lot more crossover between sales and marketing now, with sales professionals taking over some marketing responsibilities. With the role shifting, there is no other way than moving to digital-AI-based CRM systems.

All these changes and life sciences companies rushing to bring out a COVID19 vaccine have intensified competition. But competition is just a small concern that pharmaceutical organizations face. Profitability becomes a key concern with rapidly changing stringent government regulations, time lag between testing, commercialization of the medicine. And stiff competition due to lower-priced products.

Recently Mark Cuban, an American billionaire entrepreneur and investor, announced that he is investing in a business that will manufacture low-cost generic medicines. Per Forbes, the low-cost generic pharmaceutical drug company’s business plan is to maintain supply chain transparency. They intend to achieve this by buying medicines from wholesalers, packaging them, adding only a 15% markup, selling to pharmacies, clinics and health systems.”

Driving drug costs down will become a trend moving forward to make prescription medicines more affordable for end-users. The Pharmaceutical market anticipates its growth to exceed $1.2 trillion by 2022. Due to this growth, companies invest in innovative, and cutting-edge technologies to manage their most significant asset – customer insights.

According to a report by Seeking Alpha, the CRM market’s potential is estimated to be approximately $82 Billion by the year 2025, with an annual growth rate of about 12% per year. The report also suggested that if the same annual growth rate is maintained until 2034, the CRM market can grow to $228 billion. Your company is more successful in selling, maintaining customer relationships. And improve customer loyalty when users from different departments are trained on the right CRM tools.

The statistics prove that CRM helps meet the end-to-end customer acquisition demands, potential leads from the vast database of loyal customers. And keep customers satisfied with the products offered. Pharmaceutical firms gain a competitive edge through lead scoring, quote management, marketing automation integration. Most Pharmaceutical companies need to send samples to customers before actual orders are placed. They track how samples performed and what the viability is for sale to happen.

The solution to a slow-growth company is to increase its profits by keeping the existing customers happy. And acquiring a more extensive customer base. CRM in the pharmaceutical industry offers to centralize functioning by providing a common platform for maintaining the existing customer base and developing new strategies to expand in the market. Maintaining customer relationships helps ensure that customers are happy and will not be poached by competitors.

Figure: 1 How much time do your sellers spend engaging with customers?

32%on average sellers only spend 32% of their time selling.

Source: CSO Insights

59% of sellers say they have too many sales tools.

Source: Accenture

18%Only 18% of salespeople are considered trusted advisor.

Source: HBR

Why Pharmaceutical Companies Need CRM?

  • Building better relationships with customers – The directly proportional relationship between drugs released and an increasing number of patients makes it essential for your pharmaceutical company to strategize relationship building with your existing customer base.
  • Finding and utilizing data – Effectively using CRM insights by capturing useful data about patients, doctors and medicines. Developing a centralized repository with customer interactions accessible to various departments ensures transparency and enhances customer experience in the pharmaceutical industry.
  • Improving marketing strategies – Smart marketing through collateral and digital media can help gain customer attention. CRM in such customer-centric industries derives valuable insights from centralized repositories containing relevant information (of all their open and closed activities) for pharmacies, doctors and other clients. This helps sales experts to expand their customer base and increase customer loyalty.
  • Tracking campaigns – An advanced CRM software helps in campaign management for pharma companies who advertise their products. The software also increases transparency in sales costs vs. the number of leads generated and converted.
  • Effective customer service – Solving queries raised by customers immediately, reducing delays. And providing effective customer support services are must-haves to increase customer retention. Various AI-based customer service tools like assignment rules and alerts are instrumental in building a customer base.
  • Building on customer feedback – The feedback and suggestions gathered from the existing customer base help strategize better customer interaction in the future. This helps in making more refined, enhanced products and services thus, expanding the business areas. Implementing a tool to track feedback helps ensure that departments know to manage unhappy customers, and help with customer pain points.

According to a report by Capterra, 80% of the CRM users reported that their sales teams are the ones who have access to these systems, helping them acquire better quality leads and potential customers. The marketing and customer service departments come after the sales department to access the CRM software used for pipeline reporting and ROI tracking, edging at approximately 45%.

Why building effective customer relationship management in pharmaceutical industry is essential?

  • Salesforce predicts that 51% of sales pros give building and maintaining customer relationships more importance.
  • Building functional customer relationships is the paramount need for companies to increase their customer retention metrics and expand their customer bases.
  • Research conducted by Zesty showed that only 5% increase in customer retention results in up to 25-90% increase in profits for firms.
  • Building an effective customer relationship is essential for pharmaceutical companies as maintaining functional relationships with customers boosts the company’s revenue. And helps acquire large customer bases by increasing customer satisfaction in the pharma industry.

How Microsoft Dynamics 365 CRM serves your pharmaceutical company?

Dynamics 365 CRM helps improve the connection between you and your customer instantly by managing your customer engagement from Discovery to closure. It offers you the full range of functionality you need for a high-performance, motivated sales department.

Dynamics 365 CRM for pharmaceutical integrates into your ERP and BI systems to leverage your customer data’s full potential. It is used as your central information platform from leads management functions to smart customer analytics. And with AI helps you make the right moves to close deals. Move ahead of your competition with advanced sales force automation. Dynamics 365 Sales is a state-of-the-art CRM solution that integrates with your everyday tools like Microsoft Office applications to increase seller productivity, fully grasp your customer needs, and increase sales.

Figure: 2What can your company do to get ahead?

Make Smarter Decisions

How do sellers know which opportunities to pursue and how to personalize conversations?

Leverage data-driven insights and AI to guide sellers with next-best point for personalized engagement.

Free up time selling

How much time do your sellers spend on administrative tasks?

Reduce busywork by automating manual tasks and enable sellers to complete actions right from Outlook to be more productive.

Get up and running fast

How many tools does your sales team use to get work done?

Empower your sellers and help your IT staff focus on other priorities with a connected sales platform that is easy to set up, configure, and maintain.

D365 provides you the following add-ons for project-specific extensions-

  • Business intelligence with Microsoft Power BI for business development
  • Campaign management
  • Customer segmentation
  • Enterprise Resource Planning (ERP) integration
  • Project and Resource management
  • Terms and conditions data price/lists

Key Takeaways

  • You must stay at par with the growing market structures to thrive, mostly post COVID19. And adopt the new technologies as they emerge.
  • The benefits of CRM, especially with AI, has transitioned from just customer acquisition to maintenance of good customer relations and many more.
  • With all the capabilities to make your sales and marketing teams successful, the right CRM application is a key growth-enabler for your company.

Get the right tools for customer engagement and customer relationship management

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Batch Processing In Manufacturing Of Pharma Industry
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Unifying Pharma With Batch Manufacturing Process for Simplified Formula Management
Unifying Pharma With Batch Manufacturing Process for Simplified Formula Management 700 500 Xcelpros Team

At a Glance

  • Batch manufacturing or batch processing in manufacturing are conventional methods used by chemical, pharmaceutical and related sectors. These methods pose various challenges when it comes process management, formula simplification, quality checks and more.
  • Formula management is the core of process manufacturing to manage ingredients and related raw material, making it audit prone and a validated process.
  • Manufacturers are looking for solutions and software to allow the R&D and production team to work together on formulations. Manufacturers need to simplify Formula management and track changes to maintain an audit trail.

The pharmaceutical industry faces many challenges related to formula management in manufacturing. Maintaining formula, formula lines, cross-checking the data, managing raw material supply etc. can be a daunting task for the people on shop floor. Any change in formula needs to be communicated and cascaded down to production line operators to make necessary changes while running the manufacturing process smoothly.

We currently live in a modernized, connected world and it is thus essential to bring these modern hi-tech solutions to pharmaceutical formula management. After all, advanced technologies will dominate pharmaceutical manufacturing patterns, trends and changes in the coming future.

According to a survey by The Deloitte Center for Health Solutions, 68% of biopharmaceutical companies think that advances in technology will significantly impact their organizations.

Before we understand how manufacturing software can help in formula management, let us first consider the challenges in this area.

Challenges in Batch Manufacturing and the Need to Simplify Formula Management:

1.Formula Consistency:As stated earlier, pharmaceutical manufacturers need the formulations to be maintained. This would affect the quality and result of the drug (or other pharmaceutical product) being manufactured. In batch manufacturing, formula consistency plays an essential role in getting consistent results. The challenge lies in maintaining this consistency across multiple locations for different batches.

2.Communicating and Implementing Formula/Line Changes:A formula or formula line is subject to change based on batch history, planned vs. actuals, potency values or other unpredictable factors. When changes are not communicated and implemented correctly, pharmaceutical production can be challenging, especially while producing multiple lots. The cost and labor lost in such scenarios is tremendous. Communicating formula changes to all the stakeholders in the process is equally crucial to avoid quality discrepancies.

3.Maintaining and Managing Data:A pharmaceutical manufacturing facility deals with numerous formulations. Bill of Materials (BOM), ingredients, coproducts, byproducts, different formula lines, 3rd party manufacturing within a formula line, vendor management list, supply chain tracking etc. are all interrelated to formula management. This indicates extensive data generated daily, which needs to be collated, documented, and even analyzed, making it a daunting task prone to errors.

Leveraging Technological Innovations to Address Formula Management Challenges:

Today, digitization and automation have paved newer paths for conventional methods. Tools and systems developed for productiveness and superior performance can address the challenges faced by manufacturers. Speaking particularly of formula management challenges in pharma batch manufacturing, organizations can adapt batch manufacturing ERP software to facilitate:

  • Centralized record maintenance of formula, items, formula lines etc.
  • Formula management
  • Automated change communication
  • Data collation, systematic classification, report generation in the system and more
  • Track and tracing of the lot/ batch
  • Effective supply chain management
  • Production line management
  • Cost sheet maintenance and cost management

These and many more such benefits have turned pharma manufacturers’ attention towards integrating ERP in their batch manufacturing process to simplify formula management.

Figure 1:How ERP Software Can Simplify Formula Management in Batch Manufacturing

How ERP Software Can Simplify Formula Management in Batch Manufacturing

How Does Batch Manufacturing Software (ERP) Simplify Formula Management?

With the benefits mentioned above, subject matter experts and CXO’s in pharma companies know how to achieve formula simplification through an ERP software for batch manufacturing. The answer lies in the design and programming of the software which is built to

  • Manage item variants
  • Maintain purchase order sheets for scheduling, re-ordering, etc.
  • Inventory management, forecasting and order management
  • Formula recording, process control, change management and more

The payoffs of investing in batch manufacturing ERP software are numerous. With the increase in globalization, it is all the more important for pharma companies to reduce the time to market while ensuring that the product quality is not compromised. Managing the formula and how it scales for different sizes is probably the first step towards meeting those needs. With the help of high-end software, batch processing in manufacturing can be carried out effectively while simplifying formula management.

Key Takeaways

  • Pharma companies need to go digital to manage formulas for their product lines.
  • Batch manufacturing is a complex process with many factors such as scalability of batch sizes, scrap percentages, potency calculations, by product yields, etc. By simplifying formula management, pharmaceutical manufacturing companies can effectively track their batch production process.
  • There are currently many software tools/ solutions available for pharma companies to integrate into their manufacturing processes. By recognizing their requirements for formula management and batch manufacturing, they should invest in the ones that offer maximum ROI.

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How Managing Hazardous Chemical Information Solves EHS Challenges
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How Managing Hazardous Chemical Information solves the EHS Challenges
How Managing Hazardous Chemical Information solves the EHS Challenges 700 500 Xcelpros Team

At a Glance

  • Hazardous Chemicals have harmful effects on the environment and people, and it becomes the company’s responsibility to manage the hazards appropriately.
  • With strong risk assessment in place, adhering to best practices, and complying with regulatory norms, companies can potentially reduce the chemical hazards.
  • An information system that holds chemical data helps companies comply with regulatory standards such as OSHA, GHS, etc., to reduce risk and improve safety standards.
  • Safety Data Sheets and Label management systems help chemical companies manage hazard information and safely label hazardous chemicals.

Hazardous Chemicals Are Everywhere

Chemicals are found everywhere around us in almost every consumer product, from household electronic appliances such as televisions, refrigerators, and personal computers to home goods like furniture, carpets, cleaning supplies, and more. We use chemicals to purify our drinking water, increase crop production and simplify everyday household chores.

As beneficial as chemicals are, many chemicals are hazardous and need to be managed safely or can pose a serious threat to human life and the environment. Very few industries and trades in the world are absolved from chemical exposure. Accidents with chemicals can occur during production, storage, transportation use, or even disposal. Your organization and our community are at risk if chemicals are used unsafely or released into the environment where we live, work and play. Hazardous chemicals can lead to serious injury, long-lasting health effects, property damage and, in worse cases, death.

A report from the American Chemistry Council (ACC) stated that more than 96% of all manufacturing companies utilize chemical substances to develop their products.

There are reports of chemical-related accidents in organizations where it was least expected, such as the food industry.

  • Per a 2014 ABC News report a restaurant in Utah, where a woman mistakenly served a tea tainted with Lye. An employee mistook an unlabeled powdered degreaser – containing sodium hydroxide, or lye – for sugar. This degreaser was then accidentally mixed into a cup of tea, causing extreme burns to the customer’s throat and mouth. This led to expensive penalties, lawsuits, and medical bills, as well as severe damage to the business’s reputation.
  • Another such incident occurred when customers of a significant ice-cream chain were accidentally served vanilla shakes tainted with a hazardous cleaning chemical. This happened when an employee unknowingly used what was thought to be a clean mixing container. The container contained traces of a degreaser which had not been adequately cleaned, leading to extreme burns to the customer’s throats and mouths. Again, this led to expensive penalties, lawsuits, medical bills and severe damage to the business’s reputation.

Both incidents above could have been avoided with proper labeling and handling practices in place.

Figure: 1Some points to consider when you are a chemical company

Some points to consider when you are a chemical company

The impact that improper handling of hazardous chemicals have on your company can be severe – causing irreparable damage to your reputation, large penalties, being shut down, or worse, endangering human life. It is these dangers and the growing list of hazardous chemical regulations from agencies like OSHA, GHS, etc. that are driving companies to take corrective measures in identifying and eliminating these hazardous chemicals, which pose a threat to your organization, employees, customers and all other stakeholders involved.

Eliminating hazardous chemicals from common and business use is a significant challenge, and it cannot happen overnight.

  • In 2014, Adidas declared plans to eliminate the utilization of long-chain perfluorinated compounds (PFCs), a chemical type known to cause asthma and osteoarthritis in children and women. Once developed, this took two years to implement successfully.
  • In 2014, the national superstore chain Walmart initiated a policy in which it became mandatory for suppliers to phase out certain hazardous chemicals found in cosmetics, household cleaners etc. This was not a fast transition. They wouldn’t even begin to report publicly on the progress until 2016.
  • Apple eliminated using two particularly toxic chemicals, benzene and n-hexane, from its manufacturing assembly process when pressured during a campaign by Green America and China Labor Watch (CLW). The company ordered detailed testing of substances at the ingredient level to ensure the two toxins are rooted out from the facilities, as reported by Global Manufacturing.

These examples highlight one aspect of the challenges involved in successfully removing hazardous chemicals from your organization. It may not even be possible. So, if eliminating hazardous chemicals is not possible, they should be managed better to minimize or prevent chemical-related accidents.

Managing chemical footprint is not just an OSHA compliance but more a civic duty

On August 6, 2014, in a leading copper-producing company suffered a tank leakage of of copper sulphate acid contaminating two rivers and turning them orange and extremely toxic leaving more than 24,000 people to survive without water.

As a consequence, the company had to bear huge penalties and clean-up costs as well as criminal charges filed by the Mexican Government.

In recent times, this incident was a wake-up call for companies regarding the global concern chemicals have on employees, public and environmental health & safety. It also was one of the driving forces behind more stringent legislation on the use of chemicals.

Best Practices & Ways to remain compliant

Regulatory Compliance is something that cannot be forgotten, as non-compliance attracts unwanted attention from regulatory agencies – often followed by large penalties as well as a threat to your business’s licenses.

In the US in 2017, the Occupational Safety and Health Administration (OSHA) increased the severity of penalties by 80% and imposed heavy fines ranging from $7,000 up to $12,000 for noncompliance to GHS through 2016-17. For serious violations, the penalties could be as high as $70,000 to $127,000.

Organizations can avoid such fines, unwanted attention from regulatory agencies, and better manage the use of hazardous chemicals to remain compliant are as follows:

  • Adhering to regulatory norms and best practices – conducting risk assessments & safety audits for environmental hazards – offering ongoing safety training, reduces humans’ exposure to hazardous chemicals.
  • Companies should comply with the global rules, standards, policies and procedures for environmental, health and chemical safety in the workplace. They need to operate environmentally safe facilities and manufacture safe products.
  • Smart SDS Management and Labeling applications are designed with managing the impact of hazardous chemicals. This helps your organization’s compliance with hazardous chemical regulations defined by agencies like OSHA, REACH, GHS, FDA, etc.
  • Chemical manufacturers need to ensure their products are correctly labeled according to GHS standards.
  • They should also strive to remain compliant with all other regulatory policies, industry standards, and government policies to ensure safety management.
  • Periodic testing should be performed to ensure that chemicals will not cause harm public health, and if they do, they should be either re-formulated or correctly labeled.

Integrated Technology to manage chemical data

Having the right technology in place can simplify everything we do. Thankfully, most of the issues we mentioned can be taken care of with the help of applications that house chemical information designed to efficiently help chemical companies meet regulatory obligations for compliance and safety.

Figure: 2The GHS process for companies carrying harmful chemicals

The GHS process for companies carrying harmful chemicals

What is a Chemical Management system and how does it help Chemical Companies with compliance?

A Chemical Management system – integrated within an ERP like Microsoft Dynamics 365 platform – helps chemical companies with their SDS Management, Label Management and DEA controls in-line with transactions within the operational ERP system. An ideal solution can help with the following:

Regulatory Compliance

  • Helps chemical companies comply with regulatory standards and government policies such as OSHA, REACH, FDA, HIPAA, LCSA, DEA to reduce risks and improve safety.

Key Product Functions

  • Offers SDS Management, Label Management (incl. Private Labels) & DEA Management in one application.

Label Printing

  • An included Label Management function enables chemical companies to automatically print OSHA chemical labels according to the Globally Harmonized System (GHS) labeling standards. These labels can be embedded within the workflow of key operational transactions such as Production Orders, eliminating the need for manual intervention.

SDS Management

  • A SDS Management & Authoring system allows companies to maintain Safety Data Sheets (SDS).
  • Infrastructure to maintain all 16 sections of the safety data sheet – by country, language, major and minor versions.
  • Note that while an application provides the technology, workflows, and infrastructure to maintain chemical data and information, it is essential to verify the information and approve the information before generating the safety data sheet.

Key Takeaways

  • Chemical companies must accurately label chemicals in adherence to regulatory standards related to the storage, transportation, handling and disposal of hazardous materials and waste.
  • Ongoing training and proper labeling ensure chemical health and safety for the consumers and the companies handling hazardous chemicals.
  • Utilizing the right technology reduces input needed when generating labels and helps streamline the processes to ensure your organization remains compliant year after year.

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5 strategies to save big on pharmaceutical r and d costs by going digital banner
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5 Digital Strategies to Save Big on Pharmaceutical R&D Costs
5 Digital Strategies to Save Big on Pharmaceutical R&D Costs 700 500 Xcelpros Team

At a Glance

  • Pharmaceutical research and development is steadily going on the path of digitization and the companies that can leverage this digital transformation will be ahead in the curve.
  • R&D digital transformation is not a goal; instead, it is a journey wherein companies would need to strategize their moves for an effective result in terms of cost reduction and manage quality criteria of the medicine.
  • R&D constitutes a significant portion of pharmaceutical expenses and by automating, optimizing, and expediting processes through digital technology, pharma companies can turn the corner and get better outcomes of the research.

The pharmaceutical industry relies on R&D and clinical research for drug development and efficacy testing. The core of pharma operations lies in the research that goes behind formulating, testing, developing and researching a drug. That’s the reason that the R&D costs in the pharmaceutical industry are in the higher stratum. Companies, both large and small, are searching for one answer- how to reduce cost in the pharma industry? Many experts believe that they need to start with R&D digital transformation in pharma companies. This will not only effectively cut down the excess costs but will also save time and labor.

While going digital is inevitable, many pharmaceutical companies are not yet fully equipped to undergo this change. Even today’s clinical trials have changed, and the pharmaceutical industry needs to cater to this rather personalized, targeted healthcare system. By adopting digital tools and artificial intelligence for faster and more accurate R&D, Pharmaceutical companies can achieve much-needed improvement in tracking test results and performing trending and analysis. Digitized systems also help save pharmaceutical research and development costs by reducing the human effort and error rate in extrapolating the data to adjust ingredients better while producing samples.

According to Investopedia, pharmaceutical companies spend, on average, 17% of revenues on research and development (R&D), making it one of the biggest spenders in this area.

So it is essential to look at some of the ways pharmaceutical and life sciences companies can leverage the latest digital tools and technologies to minimize expenses and maximize R&D efficiency.

5 Digital Strategies for Pharmaceutical Research and Development

1.Leveraging Artificial Intelligence for Identifying Drug Molecule:Identifying a drug molecule for a particular ailment and synthesizing it can take years of research and trials in the lab. However, scientists can run data through systems and identify the potential molecule/s and their plausible effective dosage within a short time with artificial intelligence. AI tools can also help devise the chemical formula and method of synthesis for these molecules to be synthesized entirely from scratch in a laboratory under controlled settings.

2.Using Predictive Analytics for Drug Discovery and Development:Like AI tools, predictive analytics software can be a boon for scientists looking to cut down pharmaceutical expenses and improve their outcomes. With predictive analysis, scientists get to know how a particular molecule or combination of different ones behave in the drug, how long they will take to be effective, and what percentage of ingredients will impact the drug’s potency and life. This will help in deciding drug dosage, its schedule and efficacy.

3.Streamlining Drug’s Regulatory Timeline:Pharmaceutical R&D works in close collaboration with the regulatory bodies to get the drug formulations approved. This involves much paperwork, which calls for time and effort. Digitization can easily create efficient methods of running operations without compromising regulatory requirements. Automated workflows will avoid slowing down your progress and expedite your ability to go to market.

Figure 1:Pharma R&D: Digital Transformation Elements

Pharma R&D: Digital Transformation Elements

4.More Efficient Selection of Volunteers/ Patients for Clinical Trials:The current Covid-19 pandemic has seen clinical trials at a break-neck speed and a large scale across various countries globally. Such speed and scale would not have been possible without leveraging digital technologies to select the most appropriate candidates for the trials. Digital databases can also analyze and prepare best-matched trial samples of the patients to represent diverse age-groups, ethnicities and even people from various socio-economic backgrounds. Such a varied and well-matched selection can yield better and more all-encompassing results.

5.Bridging the gap between pharmaceutical R&D and academia:R&D and academia go hand-in-hand. However, the lack of correct avenues has created a gap between these two research bodies. This data (non-confidential) can easily be made available to academic institutes and even research organizations for further insights and value generation with digitization.

Apart from these strategies, pharmaceutical companies can also leverage digital technologies to streamline their supply chain and optimize operations to effectively support their R&D. The R&D digital transformation journey is not an easy one as it has many challenges and setbacks. However, pharma companies must keep in mind that the long-term benefits of digitization strategies are plenty. With the right roadmap, pharmaceutical R&D can become less resource/ revenue-intensive yet more effective in terms of outcomes.

Key Takeaways

  • While pharmaceutical companies are keen on applying digital technologies, there needs to be a strategy in place for effective implementation as per the companies’ customized requirements.
  • Pharma executives and decision-makers will need to look at digitization as an ongoing journey and prepare themselves for internal resistance, technical challenges and more.
  • Going digital is indeed the need of the hour, and pharma companies need to strategize their R&D infrastructure accordingly.
Compliance readiness in pharmaceutical companies FDA audit regulations banner
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Compliance Readiness in Pharmaceutical Companies: FDA Audit & Regulations
Compliance Readiness in Pharmaceutical Companies: FDA Audit & Regulations 700 500 Xcelpros Team

Introduction

The pharmaceutical market has faced various challenges during COVID-19, including adhering to additional regulatory standards. Due to stringent FDA pharmaceutical regulations, pharma companies always need to stay upto date on their compliance tools. Many pharma manufacturers feel that following best practices and maintaining higher quality standards would turn into a hindrance to business productivity. However, with the right technology strategy , Pharma companies can employ the same standards to increase their overall productivity.

On an average, about 4,500 drugs and devices are pulled from U.S. shelves each year.Source: US FDA

Planned and unplanned FDA audits are common in the industry. Companies that don’t meticulously maintain accurate records tend to struggle when an unplanned inspection occurs. FDA inspections are needed to ensure that companies adhere to all compliance requirements. No organization should struggle to find the necessary details to justify deviations, out of spec procedures, batch approvals, and so forth. Read on more to know why Pharmaceutical companies fail FDA audits and how they can be more prepared when a random audit occurs.

Figure 1:The six systems that are CFR 21 Part 11 compliant

The six systems that are CFR 21 Part 11 compliant

Why Pharmaceutical Companies Fail FDA Audits?

An FDA audit gives Pharma companies a perspective on how well prepared they are. A forthcoming GMP audit can even serve as a driving force for long-awaited business initiatives. Hence, pre-audit preparations are all about focusing on quality issue identification and its resolution. However, FDA audits can be stressful for the Product Quality Management Officers, Quality Risk Managers, and other personnel responsible for ensuring GMP throughout the process control. As shown in Figure 1, the six systems that are CFR 21 part 11 compliant have to installed with the right processes  to record data accurately.

There are a series of factors that contribute to audit failures in pharmaceutical companies. Given below is a brief comparison of the major ones.

Figure 2:Factors Incurring Audit Failure

Factors Incurring Audit Failure

Coping up with Various Types of FDA Audits

Every Pharmaceutical company is bound by FDA regulations and can expect an audit sooner or later. These audits ensure process compliance relevant to Standard Operating Procedures (SOPs), good manufacturing practices (GMPs), and other regulatory criteria. FDA may conduct four different types of inspections depending on purpose and timing.

1.FDA Pre-Approval Inspections (FDA pai):A pre-approval inspection may occur after the company submits a new product to FDA. This audit intends to verify the data you have included in your application and ensure that your equipment plus facilities are appropriate for manufacturing the finished product. FDA determines the pre-approval inspection with a risk-based approach, product type, and process risk. Process risk factors in development data and whether the process is appreciably new to any you have done before.

Getting a pre-approval inspection indicates that your company meets QMS requirements and can continue with the protocol. The required rule for pre-marketing audits originate from FDA, so it is possible to prepare ahead. A pre-approval inspection’s potential outcome is that the inspectors will either recommend for or against FDA approval.

2.Routine Inspections:Companies manufacturing class II and class III products will experience a routine inspection once in a couple of years. The purpose is to ensure that everything is still running according to the prescribed protocols. These audits follow the dual-level of the Quality System Inspection Technique (QSIT).

  • Level 2 Baseline QSIT: This is very inclusive and covers almost all the quality systems, corrective and preventive actions (CAPA), design controls, management controls, and process controls. Pharma companies plan FDA inspections and prepare ahead based on previous events.
  • Level 1 Abbreviated QSIT: This is a brief inspection conducted when the company has undergone a Level 2 Baseline. A CAPA system integrated with a Quality Control and batch manufacturing system help with more meticulous preparation. Information well streamlined and available at your fingertips makes you safeguarded when a sudden inspection occurs.

The type and frequency of audits largely depend on what the auditors find. If there is any public health risk unveiled during a routine check, they would possibly conduct a follow-up or for-cause inspection.

3.Compliance Inspections:These inspections review actions undertaken by a manufacturer in response to a previous audit that resulted in a noteworthy 483 observations. FDA office issues Form 483 observations when an inspection indicates violations in good manufacturing practices (cGMP). FDA will schedule a compliance follow-up audit to check if the company has responded sufficiently and has corrected its previous violations. The FDA may record current violations and opt for future regulatory action if you fail to meet requirements. A company will be well aware of this audit if it already has 483 observations or any warning letter. It should most probably, identify the issues that the FDA had found and address them quickly. It all comes down to well-managed compliance/follow-up audits, by fixing violations and be prepared with additional information concerning inventory, batches, and quality control.

4.For-Cause Inspections:These audits are in-depth and don’t happen as often as the other three. For cause audits to investigate a particular problem reported to the FDA, such as from manufacturers (recall of products, MIDR), consumers (complaints and feedback), and even employees. Companies should expect an audit in case of any health hazard or a severe product recall. There are no set guidelines here, and the type of inspection appears to be spontaneous. Irrespective of the QSIT, the auditors have a free hand to probe into other areas and aspects of the company besides the impending issue. The best way to manage this audit is to prepare for a regular FDA inspection considering you may not receive any advance notice. A real-time QMS, up-to-date management reviews, and internal investigations can adequately serve the purpose.

The Digital Connect

Almost every pharmaceutical company should comply with the FDA’s Title 21 CFR Part 11 Guidelines, commonly known as the ‘Part 11’ regulation. All records fall under this regulation when digitally stored, signed and processed as part of its business. Information security, hence, becomes significant for Part 11. All authorized users in the company require appropriate security permissions. So, managing a company’s protocols related to quality compliance can be very well achieved by digitization.

Unique usernames and passwords can provide access to user records. Moreover, this can also help monitor batch traceability with the right approvals in the warehouse. FDA audit will become straightforward when there is a record of every event in inventory with accurate time, date, and username. Electronic data further includes e-signatures, digital stamps, scans, etc. Under Part 11 compliance, these signatures must satisfy the primary & authentic cryptographic criteria abiding by a specific set of rules. The e-signatures and scans must retain an individual’s identity and the integrity of the corresponding data.

Compliance, being a perpetual process, needs continual vigilance of electronic records and signatures. Accordingly, the right digital solution for Pharma can streamline quality workflows and minimize non-compliance.

Key Takeaways

  • Pharmaceutical industries are more vulnerable to production & quality failures if a company is not proactive to handle FDA audits.
  • An effective training program ensures that SOPs and regulations are transparent to employees. The intent is to get them to prepare for an FDA audit by keeping product and quality documentation up to date.
  • Digital transformation for Pharmaceutical will hugely assist in meeting compliance criteria. It can keep pace with the increasing surge of data, make you prepared for FDA audits, and prevent the undesired consequences.

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Biotech industry challenges and their technology powered solutions banner
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Biotech Industry Challenges and their Technology-Powered Solutions
Biotech Industry Challenges and their Technology-Powered Solutions 700 500 Xcelpros Team

At a Glance

  • In the biotechnology and life sciences industry, the product’s end quality depends on the product lifecycle management process. It is essential to optimize and streamline these processes while making automation an irreplaceable component.
  • Apart from the need to expedite adaption of modern-day technology across the board, the biotech industry also evaluates tools that ranks high on ROI.
  • The ongoing Covid-19 pandemic has put the biotech industry at the front and center in terms of the need for faster tests and development of a vaccine and/ or therapeutics. This unprecedented set of events has brought forward even more pressing challenges in biotechnology manufacturing.

The biotech industry is synonymous with cutting-edge research for drugs, better health products, and more. This means the industry needs to evaluate itself for its technological quotient continually. The evaluation will also enable biotech and life sciences companies to know their exact challenges and pain areas. If we look at recent times (past decade), one of the prominent areas that require companies and researchers’ attention is biotechnology manufacturing. While the industry itself is projected to thrive, it is not devoid of some pressing issues that need to be addressed with robust IT reframing.

The global biotechnology industry growth is estimated to reach $727.1 billion by 2025, and at a CAGR of 7.4%.– Grand View Research

These numbers are both exciting and intimidating. Now is the time for the biotechnology sector to invest in fortifying their IT infrastructure to overcome their challenges and stand tall in the coming era of growth in demand.

Let us dive deep into the biotech sector’s five major problems in biotechnology and discuss technologies, tools, and systems to enable manufacturers to overcome these issues.

1.Challenges Pertaining to Funding/ Investments:Yes, the challenges faced by the biotechnology industry begin even before scientists step inside the lab! Venture capitalists are highly cautious in investing in biotech firms. Part of the reason is that the biotech/ life sciences/ pharmaceutical industries are slow-moving industries tied with many regulations. There is a fine line between drug/process acceptance and rejection. Another challenge in this area is the lack of a proper channel that can facilitate precise tracking of funds and generate insightful reports to make investors aware of the money spent. Lack of analytical insights also means that the current or potential investors do not get future predictions, which are readily available in other industries such as software and automobile.

How can Technology Answer These Challenges? Biotechnology companies should look into comprehensive Enterprise Resource Planning (ERP) systems that will enable them to track expenses and tie them back to their funding. An advanced ERP system equipped with advanced analytics features can help leverage data to generate insightful predictions and statistics.

2.Lack of Skillset:Across the board, there is a drying of talent pool for biotech experts who are adept in core subjects and technological applications. This creates a hindrance in quality production. Companies often struggle to keep their employees up-to-date with the latest happenings in the biotech industry. Personnel on the ground are not always aware of the industry trends as they are busy moving the day-to-day processes forward. Also, arranging skill upgrade training is a costly and time-consuming affair. However, the skill gap is a significant issue. Experts stress the perils of obsolete skillset and the importance of recruiting and retaining a highly-skilled workforce in biotech companies.

What Technological Solutions help Overcome Skill Gap?First off, it is crucial to choose agile, easy to use, simple to onboard applications to run everyday operations without losing the ability to capture the power of data. You don’t want to compromise the system in the effort of keeping it simple. Secondly, there are various learning and development platforms available that include individual training tools for employees. The ideal ones are embedded into the ERP system that behaves as a task recording guide. These automated platforms enable ease of access and ensure training completion without the need for individualized supervision.

3.Disconnect with Customer Expectation and Lack of Market Reading:Like any other industry, the biotech industry also faces challenges if there is a disconnect with its customers. Many companies also rely on conventional methods to read the market and gauge demands. Often there is a disconnect in the market demands vs. the in-house standards. However, this type of disconnect leads to poor customer satisfaction and misplaced product placements.

What Role Does Software Play in Establishing Better Customer Relations?A newer, more advanced AI-based customer relationship management (CRM) system tied to an operations system or ERP system can enable biotech firms to enhance their customer outreach and expedite response time. Moreover, CRM is also used to make better market predictions through thorough data analysis and trend studies.

4.Non-streamlined Supply Chains:A companies’ output is only as strong as its input – primarily people, process and software. This is also true in the case of maintaining a robust supply chain network. The Covid-19 pandemic saw disrupted supply chains because of grounded airlines and travel restrictions across various countries globally. There was also a major shift in demand of raw material, resulting in chain reaction of changes across supply chains. Such events need an agile, streamlined and optimized supply chain wherein different departments work in tandem and information is cascaded in real-time.

Figure 1:Leveraging the power of Data Science in Biotech

Leveraging the power of Data Science in Biotech

How can Biotech Companies Make Use of the Latest Technologies to streamline supply chain?The answer is an agile cloud-based ERP platform that includes the following feature set –

  • proactive planning and tracking workforce hours to a project.
  • providing supply-demand signals while procuring raw material and shipping samples.
  • process automation and approval workflows.
  • embedded training portals.
  • increased process visibility and data management.
  • real-time collaboration across various suppliers.

A robust application helps in better inventory management, communication and an overall optimized supply chain that can respond well to changes. The primary emphasis should be on moving towards newer systems and gradually letting go of legacy software. This will help the biotech industry leverage the full benefit of Industry 4.0 and make the most of its potential.

Key Takeaways:

  • Biotech companies need to rethink operations as a technology-powered ecosystem to expedite their process and ensure products are ready for quicker commercialization.
  • Modern-day AI-based ERP, SCM and CRM systems are crucial in enabling the biotech sector to become agile and more responsive.

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Managing Challenges in the Chemical Industry
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Three Ways to Manage Disruption in the Chemical Industry
Three Ways to Manage Disruption in the Chemical Industry 700 500 Xcelpros Team

At a Glance

  • The chemical industry has been at the forefront when it comes to dealing with disruptions as it serves a diverse range of sectors and constitutes of different attributes (such as raw materials, quality issues, geographical/ regional safety rules, financial instabilities, so forth.).
  • Currently, the impact of Covid-19 on chemical industry can be seen across the globe- disrupted supply chains, demand discrepancies, halted travel and fluctuation in petroleum prices have compelled manufacturers to deal with various chemical industry issues all at once.
  • Digitization has disrupted the chemical industry even before the pandemic started and the combined effect has been both challenging and a blessing in disguise for the chemical manufacturers.
  • Through the right tools and systems, the chemical companies can pave their path in the era of digitization and transform for a better future.

The challenges in chemical industry have been varying in nature as the industry relies on a large variety of stakeholders and is an asset-intensive sector. The past few years have been all the more challenging in chemical industry management because of the onset of Industry 4.0 and ensuing changes in IT infrastructure. However, the digitization effect also came as an opportunity for chemical manufacturing and distribution companies to leverage latest technologies to reduce time to market, optimize processes and manage supply chain challenges in the chemical industry with enhanced efficiency.

According to a 2020 survey by PwC, 42% of chemical company CEOs said they would be investing in digital operations and related technologies in the coming 12 months.

To remain on top of the digital game, companies must understand and approach chemical industry issues fully equipped with advanced technologies and comprehensive strategy. Let us have a look at some of the significant challenges in the chemical industry:

1.Managing Data in the Time of Information Abundance:One of the significant challenges of digitization in the chemical industry is an overflow of data in the sector. Top floor decision-makers are looking for ways to store, analyze and generate insights from the abundant information flow. Data analytics remains a tricky area for many chemical manufacturers. Legacy systems are still part of many manufacturers’ IT infrastructure and there are discrepancies in information flow management because different functions work in silos.

2.Overcoming the Unpredictable Nature of the Market:Market fluctuation is another major cause of chemical industry disruption. The ever-changing commodity prices put manufacturers in a sticky spot in terms of finances. Also, the impact of the covid-19 pandemic was felt in the form of demand pattern changes – there has been heavy demand globally for sanitization and hygiene products. Such fluctuations are hard to forecast, and most chemical industry management struggles to keep up with these changes.

3.The Need to Go Agile:The world is moving fast, and the manufacturing industry is looking to catch up. Chemical companies are primarily looking for ways to go agile for better delivery patterns, improved change management and measurable productivity. However, companies face different challenges when going agile such as financial constraints, resource skill management, and resistance from employees.

While the challenges are aplenty, there are ways to overcome chemical company issues. Let us have a look at how companies can manage the disruption in the chemical industry.

1.Investing in Fortifying IT Infrastructure:Chemical companies need to turn to technology as-required but a long-term roadmap is required that justifies the investment. By investing in high-end tools and systems, chemical manufacturers can ensure that their processes are automated, the data is collated and leveraged to generate insights for better business decisions, and the operations are optimized. Going for comprehensive enterprise resource planning (ERP) tools with embedded BI tools can transform how chemical companies approach their operational requirement.
BASF, the global leader in chemical manufacturing, made use of the Microsoft 365 to improve the transparency and efficiency of virtual teamwork within our global family. This choice was a direct result of the company’s move towards agility.

2.Supply Chain Optimization:Another area where chemical companies can turn a corner and embrace the ongoing changes is to optimize their supply chain. Bettering stakeholder communication, facilitating real-time inventory monitoring, and avoiding stock-outs or bottlenecks by proper warehouse management are some of the steps that manufacturers need to take for a well-functioning supply chain.

Figure 1:Areas getting benefitted with ERP in chemical manufacturing

Areas getting benefitted with ERP in chemical manufacturing

3.Prioritizing Innovation:The highly disruptive digital landscape will multiply the challenges in the chemical industry. However, organizations can resolve these challenges by encouraging innovation. Chemical companies should invest in better market research, newer and more efficient production processes, and out-of-the-box customer response management initiatives. These would enhance overall productivity and also help companies in cementing their position in the volatile market.

In conclusion, disruptions are excellent catalysts to improve processes within a chemical company. Businesses can equip themselves with the latest technologies on a path to digitization.

Key Takeaways:

  • Chemical companies need to look at disruptions as opportunities to overcome challenging times.
  • Latest technologies play an imperative role in chemical manufacturing and aftermarket services as well.

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GHS compliance guide for chemical industry
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Managing GHS compliance in a chemical company
Managing GHS compliance in a chemical company 700 500 Xcelpros Team

At a Glance

  • The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) offers a blueprint for handling hazard information through labels and safety data sheets.
  • OSHA raised its penalties related to occupational hazards almost by 1.8% on 15th January 2020. Any violation of the recognized safety standards would cost a chemical manufacturer a whopping fine ranging from $9,639 to $134,937.
  • GHS compliance effectively minimizes labor costs owing to fewer accidents and health problems.

For any drug or chemical manufacturing company, GHS compliance guide rests on four central pillars: Hazard classification, Chemical Labels, Safety Data Sheets and Employee Training. For chemical companies across the globe, it’s an ongoing challenge to remain compliant with GHS standards in the face of ever-changing regulations. For just about any chemical manufacturer, the task of collating and reporting on every available data point through safety data sheets and chemical labels can be almost impossible. This necessitates the need to adopt chemical industry-specific software solutions that help generate and manage safety data sheets and labels according to GHS guidelines. These software solutions enable companies to:

  • Create a safer work environment for all employees across multiple manufacturing units.
  • Automate critical chemical management processes like GHS labeling and generating Safety Data Sheets.
  • Boost process efficiency and reduce fines incurred from breaches in compliance.
  • Leverage employee training mechanisms, expert resources and applications that focus on the handling and disposal of hazardous chemicals.
  • Converge multiple operational functions in a single dashboard for smart analysis.
  • Conduct training programs on employee safety.
  • Build credibility and brand recognition in the market.

Figure 1:Key Operational Principles of a Chemical Management System

Key Operational Principles of a Chemical Management System

The image above makes it very clear that for GHS compliance, the two most critical working processes in a chemical management system include GHS Labeling and Safety Data Sheets. Let’s focus on how a Chemical Management ERP system lends itself to GHS labeling and SDS chemical management automation.

Chemical Labeling and GHS

Chemical labeling is all about conveying critical hazard information related to a particular chemical at a rudimentary level. Six key elements make up the chemical labels, including.

  1. 1.The Signal Word
  2. 2.GHS Symbols or Hazard Pictograms
  3. 3.Manufacturer Information
  4. 4.Precautionary Statements
  5. 5.Hazard Statements, and
  6. 6.Identifiers

Figure 2:GHS Compliant Chemical Label

GHS Compliant Chemical Label

With regulations constantly changing, chemical manufacturers are persistently working towards adopting technologies that seamlessly work with their existing systems to deliver process efficiency and compliance at the same time. Before understanding how the chemical industry has worked towards mitigating challenges, it’s important to understand the most harrowing challenges plaguing the labeling process of the chemical industry, including

  • Identifying relevant, compliant data to be put on container labels.
  • Finding labels that are durable and can withstand the impacts of harsh chemicals.
  • Finding the correct size for GHS labels for containers of different size.

When it comes to chemical management, labeling is one of the most critical tasks. It’s only through proper labeling that companies can track chemicals from manufacturing to delivery. Most chemical industry software solutions based on the ERP framework deliver the following solutions to the problems mentioned above, including.

  • An infrastructure to house hazard information such as pictograms, hazard statements, provisions for inserting supplier information, etc.
  • Provision for customization of GHS chemical labels for different sizes used on various containers.

These benefits are very tangible and apparent, but technical intervention in labeling can be much greater, encompassing the entire business.

Business Benefits of GHS Labeling

  • Boost Supply Chain
    • Track chemicals with all the requisite details.
    • Minimize re-labeling, incorrect shipments, inventory problems.
  • Change Management
    • Implement change real time.
    • offer standard templates and system for change Management.
  • Cost Efficiency
    • Minimize shipping delays, unnecessary operational steps.
    • Error proofing and data management.
  • Compliance
    • Integrate third parties in labelling systems.
    • Minimize manual shipments.
  • Process Efficiency
    • Integrate marketing and branding information.
    • Manage multiple languages, color printing, regulatory standards.
  • Business Expansion
    • Retrieve data from multiple systems.
    • Minimize duplication for a single product.

OSHA has raised its penalties related to occupational hazards almost by 1.8% at the start of 2020. Any violations of these recognized safety standards would cost a chemical manufacturer any number of fines ranging from $9,639 to $134,937.

It’s not just GHS labeling requirements, but complete SDS chemical management solutions that would best help chemical manufacturers minimize their chances for huge financial penalties, driving process efficiency along with compliance at the same time.

Safety Data Sheets and GHS

Safety Data Sheets (SDS) are used to capture all hazardous chemicals’ information. SDS is not only the first point of hazard information collection and reporting. The safety data sheet form the basis of GHS labeling. With the business ecosystem becoming extraordinarily dynamic and constantly changing, becoming more stringent, there can be absolutely no room for error in safety data sheets. Chemical companies opt for SDS authoring and generation software that work in tandem with their existing ERP system. These SDS tools bring a lot to the table for these organizations, including:

  • Real-time safety data sheet updating features
  • Seamless integration with existing ERP systems
  • Automatic generation of SDS sheets
  • Storage capacity for individual product data
  • Applications to update multiple sheets at the same time
  • Options for multiple language translations
  • Ability to create standardized data for every chemical formulation
  • Repository for multiple GHS versions, Canadian WHMIS, and OSHA Hazcom

Integrated Chemical Management (iCM) is a solution designed to offer both GHS labeling and SDS chemical management services simultaneously. This solution pairs with Microsoft’s Dynamic 365 ERP to deliver:

  • Real-time SDS authoring and label creation at the same time in compliance with GHS.
  • Deliver process automation and operational efficiency.
  • Minimize the cost of customization and third-party integration cost.
  • Minimize the time and resources required to manage data sheets and labels.

Key Takeaways:

  • Managing multiple third parties for SDS management and GHS labeling can be a challenge. Implementing a powerful, integrated solution that does both can make a huge impact on efficiency and performance.
  • Process and compliance in a chemical company go hand in hand, and the more the integration is facilitated, the better it is for optimizing operations within the plant.
  • Being Agile through integrated technologies is a crucial need in chemical manufacturing and the ability to respond quickly to changes in compliance makes a chemical company potent as a business.

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References:  GHS Label Compliance

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