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Process Optimization

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

Ways to enhance customer experience in pharmaceutical industry banner
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Ways to Enhance Customer Experience in the Pharmaceutical Industry
Ways to Enhance Customer Experience in the Pharmaceutical Industry 700 500 Xcelpros Team

At a Glance

  • The face of the pharmaceutical industry is rapidly changing from R&D to directly interacting with their customers.
  • With changing demand and expectations, technology will be more important than ever to establishing a fortified system that brings together businesses and their customers.
  • The conventional chain of interaction between the pharmaceutical sector and its customers involving healthcare professionals is set to undergo a change to help the pharmaceutical industry better understand and manage customer expectations.

For years the pharmaceutical sector has operated in silos, in terms of understanding and managing their customer base. While there has been considerable change in the technology used for research and development, when it comes to customer experience and engagement in the pharmaceutical industry, there is still a long way to go. There is a growing need for the merging of customer management, meeting demands for particular drugs etc. using complete solutions like Microsoft’s Dynamics 365 line of products.

It’s become obvious that technology will play a critical role at the forefront of customer engagement, sales and marketing departments. In this article, we explore how adopting cutting-edge tools and software pertaining to customer relationship management (CRM) can benefit organizations.

1.Going OnlineDue to the outbreak of coronavirus, there was a sudden and steep decline in financial outcome across multiple industries in the first quarter of 2020. The market slowdown led to slower investments, reduced credit timescales by banks (leading to delay in funding), lack of sufficient security packages, covenant limits, etc. The financial impact has caused significant distress for the chemical industry, and top-level executives had to rethink their business procedures to ride through these distressing times.

2.Leverage Technology for Stakeholder ManagementIn a connected world, it is essential for pharmaceutical companies to understand and cater to the needs of different stakeholders in order to ramp up sales and reach their target customers more effectively, including generic drug manufacturers, biotech firms, physicians, chemists and more. Technology plays a crucial role in this scenario by providing tools like the aforementioned Microsoft Dynamics 365 products that enable sales teams to connect with different users through a centralized system.

Figure 1:Customer Engagement in the Pharma Sector Through Technology

Customer Engagement in the Pharma Sector Through Technology

3.Redefine Customer Engagement Strategy with a Sales-driven ApproachFor years, the pharmaceutical sector has by and large been driven through its approach towards research. While the competition for customer aquisition in the pharmaceutical industry, retention and expansion has always existed, not all pharma companies are known for aggressive sales-driven strategies. With the gap between the customer and pharma sector decreasing over time, the sales executives need to overhaul their strategies to directly engage with their customers and turn things around. Companies will be able to mitigate the costs involved in a conventional hierarchical setup for many of their products, and customers will have direct and easy access to drugs or other healthcare products that don’t require a physician’s supervision. An intelligent digital sales-driven approach can also boost revenue of pharmaceutical companies and keep them in sync with demands and expectations of their customer-base.

Key Takeaways

All said and done companies need to make better use of technology available to their sales and marketing departments in order to create an enhanced pharmaceutical customer experience in the pharmaceutical industry. Today, pharma companies that show agility and precision in adapting newer technologies, tools and software will lead the way in pharma customer engagement and retention. Below are some key takeaways –

  • Pharmaceutical companies need to embrace technology for a better understanding of customer expectations.
  • There is immense competition across the pharmaceutical market for customer acquisition and retention, that is achievable only by adopting a modern, sales-driven digital technology.
  • Use of transformative tools and processes are some of the best ways to manage all customers effectively.

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References: The Importance Of A Great Customer Experience For Pharmaceutical Companies

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6 Challenges in the chemical industry due to COVID-19 and the future ahead
6 Challenges in the chemical industry due to COVID-19 and the future ahead 700 500 Xcelpros Team

At a Glance

  • As the world braces itself from COVID-19 recovery, decision-makers at significant chemical companies are looking for ways to realign their operational and manufacturing strategies to be able to sustain and grow.
  • Liquidity and capital resources impact the business, causing financial pain areas for the chemical industry.
  • The industry has also faced challenges due to disrupted global supply chains, labor shortage, dwindling demands for one industry and growing demands for others, and many more issues.
  • With the strategic overhaul, reinvention of smart factories, investment in automation, and other robust enterprise software, the chemical industry can turn the tide.

Like almost every other industry, the chemical industry encountered unplanned hassles in 2020 due to the Coronavirus global pandemic. Practically every department in chemical companies has experienced the ripple effects of a market slowdown. Things are still uncertain in terms of the supply chain’s stability, workforce capacity, changes in global trade regulations, etc.

Approximately 41% in the chemical industry are concerned about the effects of Covid-19 on workforce and reduction in production.
Approximately 23% are looking at disrupted supplies are a red flag.– Per a survey by PricewaterhouseCoopers

While global supply chain disruption has impacted businesses, the chemical industry can take advantage of certain factors like:

  • Increased demand for raw material required for hygiene products and sanitizers across the globe.
  • The drop in oil prices offering a chance to acquire oil-based raw material at a lower cost.
  • Dependence of many major and minor sectors on the raw material provided by the chemical industry.

There are also various strategic and operational changes that the decision-makers at chemical companies will need to help their companies sail through this crisis with minimal damage. The chemical industry also needs to prepare itself for the post-COVID era. However, before we get into plausible solutions, it is imperative to understand the challenges in chemical industry. Let us look at six major challenges that the chemical industry is dealing with due to the coronavirus crisis.

1.Liquidity and Investor IssuesThere was a sudden and steep decline in financial outcome in the first quarter of 2020 due to COVID-19. The market slowdown led to investment shortage, lower credit, etc. The financial impact has caused significant distress for the chemical industry, and top-level executives rethink their finance allocation policies to ride through these distressing times.

2.Shortage of Workforce and Reduced Production RateMany regions are still not back to normal and need to follow social distancing norms to avoid the coronavirus spread. The additional rules in place limit the ability of chemical production facilities to work at full capacity. Even the workforce that does not operate on the shop floor has to either work from home or stay absent. Current issues in the chemical industry lead to reduced productivity and lesser output from the production plants.

3.The Issue of Disrupted Supply ChainsWith the slowdown of all travel types (especially international air travel), there have been significant supply chain challenges in the chemical industry across the globe. The chemical industry is heavily dependent on different stakeholders working in harmony for seamless functioning. Businesses have taken a massive hit, and there are issues related to delays in obtaining raw material, delays in shipments, blocked consignments, and more.

Figure 1:Benefits of a Connected Ecosystem for Inventory Management

Benefits of a Connected Ecosystem for Inventory Management

4.Discrepancies in the Demand of Raw MaterialChemical companies supply different raw materials to various industries, and they make arrangements for these stocks based on their orders, estimates, and market scenario. However, the lockdowns imposed due to the coronavirus pandemic caused many industries like automobile and consumer goods to cease their production. In contrast, other industries like hygiene goods, pharmaceuticals, and medical equipment manufacturing sectors had to ramp up their production capacity. An imbalance in the market caused discrepancies in the demand for raw materials, and the chemical companies have to realign their inventories to suit the changing needs. The market is recovering however still carries the effects of the pandemic.

5.Facilitating Social Distancing at SitesWorkers who are back to facilities require retooling to expedite work and play catch-up on customer orders that were previously halted. Many chemical companies have made drastic changes to their plants to provide a safe atmosphere for their workforce. This atmosphere involves regular sanitization of the premises, facilitation of social distancing, temperature checks of the staff, interatcion and collaboration through digital tools, etc.

6.Changes in Strategy for the Post-pandemic EraThe strategists and top executives at chemical companies have a robust and demanding job at their hands to realign their game plan for the post-pandemic era. Replanning involves gauging the market’s pulse at a granular level, understanding the varying needs for different chemical compounds, and providing investors and business partners with the plan’s visibility. Higher visibility drives the requirement to onboard agile analytical tools in conjunction with their manufacturing execution and warehouse management systems.

While there are many challenges in the chemical industry, they can get these issues addressed with comprehensive, all-inclusive technology. Companies need to evaluate a business solution that provides end-to-end Supply Chain Management, Financial Management functions plus embedded analytics to realign their processes and gain in depth visibility of the operations.

2020 has seen a massive shift in the overall functioning of chemical companies, which has enabled the need for proper planning, extensive use of robust integrated tools, and timely actions. By retooling to make themselves more agile, chemical companies can ride this storm out and progress forward. Ability to adapt to rapid changes in business is now one of the major OKRs within a Chemical company. Enterprises that wish to differentiate themselves in the Chemical industry need to transform from traditional to becoming new-age companies.

Key Takeaways

  • The chemical industry needs to be agile and flexible to gauge the changing needs and serve their best during these trying times.
  • The right digital tools help chemical companies to not just strategize but also effectively execute to grow.

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Modern Methods to Best Manage Pharmaceutical Quality Control
Modern Methods to Best Manage Pharmaceutical Quality Control 700 500 Xcelpros Team

At a Glance

  • Quality control processes in the pharmaceutical industry are known for their rigorous and meticulous nature. It is of utmost importance to maintain the highest safety standards during drug manufacturing and managing pharmaceutical products.
  • With Industry 4.0, automation, Big Data, Machine Learning, Artificial Intelligence and systematic operations management, different Enterprise Resource Management (ERP) tools have become integral in the pharmaceutical quality control processes.
  • Advanced technology is undoubtedly becoming the backbone of futuristic quality assurance in the pharma and biotech industry.

The pharmaceutical industry stands at a pivotal conjunction point of technology and subject matter expertise. With times changing fast, the pharma sector’s processes and operations evolve to enhance accuracy and reduce efforts and time consumption. However, quality control is a highly complex field where the slightest of errors can lead to severe health consequences. At pharmaceutical companies, scientists and top executives look at the latest technologies like complete digitization of operations, automation at manufacturing units, and Big Data and Machine Learning to maintain records.

The (pharmaceutical) industry increasingly wants more out of their data, and the focus in manufacturing data analysis is about quality, not quantity.– Joe Haugh in an article for the European Pharmaceutical Review

The ongoing Covid-19 pandemic and the ensuing search for a vaccine has shown the world that with the help of technology, it is possible to witness a never-seen-before feat of producing a potential vaccine candidate in mere months for a novel virus. Even the numerous clinical trials and related reporting are performed unprecedentedly with the latest tools. Manufacturing and supply of potential drugs to even the remotest parts of various countries are plausible with robust ERP models and streamlined supply chains.

Figure: 1Pain Points: Quality Control in the Pharmaceutical Industry

Pain Points: Quality Control in the Pharmaceutical Industry

Let us take a deep dive into understanding the different ways technology helps reshape methods of quality control in the pharma sector.

01.The Automation Effect: Mitigating Errors, Reducing Process Time and Saving Efforts

Businesses have discussed automation in pharmaceutical manufacturing for a long time, but this technological advancement is a boon in quality control. Pharmaceutical companies can leverage automation within quality assessment by reducing manual documentation efforts to cut margin errors and automatically carry out a quality check for batches or samples.

02.A Robust ERP System: The Way Ahead for Comprehensive Quality Control Process Optimization

Quality control happens at various stages throughout a drug’s lifecycle. This involves different stakeholders spread across multiple departments and most probably other locations. Conventional methods or legacy systems involved manual record maintenance, report generation and communication, leaving scope for errors. The traditional approach also was highly time-consuming. Companies can effectively address the issues with a robust ERP system. A system that provides a centralized database visible to all stakeholders in real-time helps drive better business decisions. The system should leave no scope for communication gaps and help align business objectives with workforce activities. Through report generation and data analysis within the ERP system, companies can make adjustments to operations and subsequently improve productivity.

03.Internet of Things (IoT): Creating a Centralized Database for Enhanced Visibility in QC Labs

Most traditional quality control departments in pharmaceutical companies involve manual work where Quality Control and Quality Assurance work in tandem. However, the cumbersome nature of the job at hand- manual documentation, record maintenance for individual drug components, random testing records, call-back records, etc. creates caveats and increases error margin. IoT helps create a blueprint for various processes through device integration to feed in respective data and insights. This helps in maintaining transparency across all levels of quality control and pharmaceutical quality assurance processes.

04.Digitized Change Control Management: Fast-tracking Quality Assessments in Case of Any Changes

Drug manufacturing is subject to changes throughout its lifecycle. In a conventional QC lab, these changes are recorded and communicated manually to various stakeholders, who then carry out respective tests and derive insights. These insights also drive changes required on a work in process batch. With the help of a digitized ERP system, changes can be communicated in a central system and all the stakeholders can evaluate real-time quality data. This expedites the quality assessment process and helps record maintenance quickly refer to relevant documents during quality inspections.

05.Automated Data Analytics: Applying Machine Learning to Derive Insights

Quality control techniques in pharmaceuticals involve working with precise data. With machine learning and automated analytics, pharma companies can leverage the same amount of data to generate maximum insights.

What does Quality Control in Pharmaceutical Look like in Microsoft Dynamics 365 ERP?

The evolution of Dynamics 365 to a customized, purpose-based system makes it a comprehensive solution for a quality control pharmaceutical lab. It creates a central database, alerts all stakeholders of defects, helps in record maintenance and instant report generation. With Microsoft Dynamics 365 Finance and Operations, life sciences companies can manage in-coming/ in-process inspections for batch and continuous manufacturing. Track and trace functions enable pharma companies a base for better inventory management and can be especially helpful during drug call-backs, in case such a situation arises. On top of the Integrated quality management that includes SOP, CAPA, Deviation functions will help Pharmaceutical companies manage Quality compliance.

Key Takeaways

  • The pharmaceutical industry is cautiously yet steadily adapting to technological advancements. With advanced quality control, pharma companies can make great strides in assurance, uniformity and transparency.
  • Advanced technological applications are must-haves to address the pain points in pharmaceutical quality control.
  • The fast-paced, demanding world of drug manufacturing requires a fast-track yet highly stringent quality control mechanism, which is made possible through cutting-edge technologies and tools.

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inventory management strategies
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Top 4 Efficient Inventory Management Strategies
Top 4 Efficient Inventory Management Strategies 700 500 Xcelpros Team

At a Glance

  • Challenges of an inventory can be both daunting and persistently confusing for shippers/ suppliers; however, a strategic re-evaluation can do wonders to your inventory management.
  • Accuracy, agility, and quality seem to be the main driving factors in today’s inventory management scenario.
  • Companies need to make the necessary changes to their approach to inventory management strategies today to have a seamless supply chain and, eventually, a satisfied customer base.

As technologies and the latest strategic trends bring on a blanket change across various industries and their related subsets of functions, organizations need to adapt to these trends. Such adaptations can at first sound overwhelming, but proper planning and execution can help you in the long run. Inventory management has come a long way from being just a function related to buying, stocking, and selling. In today’s digital era, managing an inventory entails predicting stock-outs and preventing them, enhancing workflow efficiency, providing real-time information to various stakeholders, and supporting large scale productions. The unprecedented growth of the e-commerce sector has given rise to customer expectations that can be daunting to the sellers and suppliers. Today’s supply chain culture is all about being the fastest and the most accurate. Thus, both B2B and B2C markets continually look for ways to efficiently manage their inventories’ challenges.

48%

of supply chain and transportation executives say they are experiencing the need to reevaluate warehouse locations due to shifting trade patterns resulting from changes in the U.S. economy.

Source: A Report by Forbes Insight

Whether you are a manufacturer, supplier, or retailer, the road ahead to managing your inventory effectively is full of complexities as well as opportunities. Let us look at various good inventory management practices that will help you unravel these problems while tapping many efficient inventory management options.

01.Be Efficient When You Go Omnichannel

These days, the customers/consumers are empowered by various online applications, e-stores, and even physical shopping options to complete their order. As a retailer who wants to tap into these different distribution options, one needs to dive into omnichannel retailing. But this requires accurate and highly efficient management of stocks and their distribution across various channels. A complex omnichannel inventory requires a central data management system, effective track and trace mechanism, and sustainable storage options to operate seamlessly. An omnichannel store that operates both physically and online needs to purchase data and patterns for predictive analysis to preempt customer demands and stock their inventories accordingly.

Figure 1:An Omnichannel Retailer’s Inventory

An Omnichannel Retailers Inventory

02.Create an Efficient Connected Ecosystem

Long gone are the days when inventories were simply warehouses located close to the supplier base and managed as a separate function. With advanced, cutting-edge technologies, everything is connected today. Thus, to overcome the inventory management problems, you need to create an efficiently connected ecosystem where different functions work in tandem while sharing data, exchanging real-time developments, and being governed in an optimized way.

To help you manage your inventory’s problems with ease, speed, and accuracy:

  • Moving your data from legacy platforms to Cloud.
  • Implement process automation to simplify laborious manual tasks.
  • Use Artificial Intelligence and Machine Learning to preempt stock-outs.
  • Apply Advanced Analytics for accurate inventory reporting.

Figure 2:Benefits of a Connected Ecosystem for Inventory Management

Benefits of a Connected Ecosystem for Inventory Management

03.Revisit Your Warehouse Location design

In the past, inventory locations were not always well-managed and streamlined based on supply, consumption, and demand. With cumbersome planning and different modes of transportation, warehouses would ship goods to the desired locations. However, in today’s times, inventories cater to multiple channels and changing consumers’ demand patterns. This has made companies rethink their logistics strategy. Companies are setting up distribution centers closer to the customer-base to help streamline order fulfillment. Also, these distribution centers, when integrated through a common and efficient warehouse management software, can share data and prevent stock-outs.

04.Balancing the Influx of Inventory

There has always been discord between stocking up on inventory and the actual space available in shippers/suppliers’ warehouses to store the inventory. Sometimes, shippers miscalculate the future demand, while other times, they fear the increase in the price of goods. Whatever may be the scenario, this influx of inventory and the lack of actual physical space can lead to a menace for distribution centers. This can also lead to damage of goods, loss of perishable items, and a mismanaged inventory. To avoid this kind of influx, suppliers can get supply chain experts on board to use technology to their advantage. Tools and applications like MRP with AI and Advanced Analytics can accurately forecast customer demands. A good and robust software system to track the inventory items will prevent excessive purchases and stock-ups.

Inventory problems have always been the peril of supply chain management. You can be better prepared using the latest technologies with features like track and trace through LPN, a mobile supply chain, use of barcode, labeling, etc. By rethinking and replanning your supply chain process, you can proactively streamline inventory. A smooth supply chain needs to have a well-managed inventory, and taking the right steps in this direction will help you build a higher business value.

Key Takeaways

  • No two companies can have similar inventory requirements and structures; so, you need to assess your needs to optimize and manage inventory challenges.
  • A complex inventory requires stringent workforce management, change management, skill force updating, latest technologies, and application of intelligent tools to be managed seamlessly.
  • Contingency plans need to be in place for disruptions in inventory management, giving your company the ability to plan for unexpected situations.

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