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Pharmaceutical

Reducing the Risk of Pharmaceutical Non-Compliance with Technology
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How Technology Can Reduce the Risk of Pharmaceutical Non-compliance
How Technology Can Reduce the Risk of Pharmaceutical Non-compliance 700 500 Xcelpros Team

At a Glance

  • Pharmaceutical manufacturing companies are investing more money and resources to assure adherence to regulatory compliance.
  • Non-compliances need to be managed and tracked through their lifecycle, and using a digital platform eases the end-to-end process and follows it to completion.
  • The first step towards regulatory adherence is to thoroughly understand the compliance requirements and form a dedicated process to comply.

Many pharmaceutical companies have restructured their financial and resource allocation models to invest more in adhering to compliance. Compliance requirements around the globe have grown in past decades. Each country has differences in safety standards, and global companies have to ensure they meet local requirements. Companies need better management and tracking of non-compliance. This article discusses the ways to reduce risks of non-compliance in the pharmaceutical industry. Manufacturers and distributors have dealt with compliance issues in the pharmaceutical industry. Companies have to conform to multiple complex and varying regulatory norms and safety standards. All the stages involve detailed compliance requirements, from procuring raw material to producing finished goods and quality testing of the final product. These complexities have further multiplied in recent years because of:

  • Addition of several more regulations globally in the pharmaceutical and life sciences sector.
  • Differences in the rules and regulations related to pharmaceutical compliance across different geographical regions.
  • Absence of a viable infrastructure to manage and track non-compliance.
  • Unclear SOPs and redundant record maintenance practices often lead to pharmaceutical manufacturing non-compliance.

Apart from these, non-compliance can result from other various smaller factors like faulty equipment, maintenance issues, faulty formula controls/ lab controls, etc. All contribute to quality compliance in the pharmaceutical industry. This is the reason that pharmaceutical and life sciences companies spend a fortune to avoid non-compliance. The costs of non-conformity are very high and thus, companies want to make sure that they adhere to the rules and regulations.

40%

of the pharmaceutical IT budget is spent on regulatory compliance.

Source: Gartner

Figure: 1 Major Factors Affecting Compliance in Pharma

Major Factors Affecting Compliance in Pharma

So how can pharma companies leverage technology to mitigate the consequences of non-compliance? Here are some ways that experts believe newer tools and innovations can help in better pharmaceutical compliance management:

1.Making use of the right tools: Documentation and record maintenance are a big part of the pharmaceutical industry’s compliance processes. Conventionally these documents have been manually maintained, which can lead to both errors and oversights. However, newer pharmaceutical software platforms come with the ability to gather and store data efficiently. It is essential to track user behavior and user audits to ensure compliance. A compliance management system with audit tracking and reporting tools can avoid non-compliance and improve overall product quality.

2.Leveraging integrated labeling: Pharmaceutical companies struggle to manage compliance as they enter newer territories and markets. There are different labeling practices and regulations which are challenging to manage. The labeling practices keep going through changes and updates even in familiar territories, making it essential for pharmaceutical companies to stay on top of these changes. To tackle labeling issues, companies can leverage the automated labeling platforms wherein the data can be auto defaulted from the different processes such as receiving, production and shipments. Inbuilt label printing within business process workflows avoids user errors and enforces process compliance. With integrated labeling within the ERP, users are equipped to manage changes and make the labeling process run smoothly.

3.Standardizing processes across the organization with a common technology platform: Major pharmaceutical manufacturers and distributors are tying up with technologists to deploy a common technology platform and implement it across their locations. Companies that invest in business process uniformity will witness business improvement and growth. Quality issues often arise due to non-compliance of processes, undefined procedures, changing equipment and labels, etc. Many companies find that quality is impaired when processes vary from location to location. With the latest technology platforms, organizations can centrally assure that standardized practices are being followed across all locations.

4.Effective strategies to managing data: Non-compliance in the pharmaceutical industry is often a result of a poorly managed information loop. Systems supporting pharmaceutical manufacturing and distribution generate enormous data. When data is managed systematically, the right information is made available to appropriate users. The right system can notify regulatory changes, changes in formulations, or process variations. Every data point serves as a crucial piece of information that can guide users to be more proactive in conforming to business processes. Data management and analytics platforms are equipped to enable pharmaceutical companies to report anomalies as they occur. Dynamic reporting cumulatively helps in better quality compliance.

The Covid-19 pandemic has added impetus on pharmaceutical companies to adhere to regulations while working on therapeutics and vaccines at an unprecedented speed. Companies that leveraged the latest machine learning, analytics, and other IoT tools/ platforms, perform better.

Pharmaceutical companies are always looking for newer methods to balance quality compliance and productivity.

Johnson & Johnson, for instance, has a comprehensive quality management framework in place for continued focus on compliance and quality, amongst other essential parameters. The latest technologies and innovations back this framework.

All in all, reducing the risks pertaining to compliance issues in the pharmaceutical industry requires a well-planned and executed technological strategy. With the latest innovative platforms, companies can ensure adherence to quality compliance regulations in the industry.

Key Takeaways

  • ERP, automation, data analytics, and machine learning are imperative in enabling pharma companies to mitigate the risks of non-compliance.
  • To reduce the consequences of non-compliance, pharmaceutical companies need to strategize their technological moves.

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References: Reducing the Risk of Noncompliance

Rethinking pharmaceutical strategies in the new normal banner
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Rethinking Pharmaceutical Strategies in the New Normal
Rethinking Pharmaceutical Strategies in the New Normal 700 500 Xcelpros Team

At a Glance

  • The year 2020 showed the world that every sector has to be prepared for disruptions of unprecedented scales. This has been especially true for the pharma industry, which already had stagnant operational models and a lack of consumer connection.
  • Working on a new pharmaceutical strategy model is a necessity and top executives at pharma companies concur that there is a need for integration of the latest technologies in pharmaceutical and life sciences operations.
  • Industry leaders have demonstrated that during difficult times they are able to quickly respond to changes and are nimble in adopting newer ways of running operations. This quick-to-adopt way of leading will enable pharmaceutical companies to succeed in the new normal.
  • Agile technologies and tools that streamline processes will be indispensable in the latest roadmap of pharmaceutical strategy.

The pharmaceutical sector has been traditionally apprehensive towards adopting newer technologies and methodologies. Compared to other industries, operations management within the pharmaceutical industry has not been quickly modified or completely transformed. C-suite executives are now looking to overhaul their pharmaceutical strategies ensuring growth in the new normal.

During the pandemic pharma supply chains were adversely impacted and witnessed supply-demand discrepancies. Companies that could quickly adapt rose to the challenge. The spirits have changed since the onset of the pandemic and so has the market. Thanks to visionary leaders, pharmaceutical companies began work on something that the world had never witnessed before – to develop and test drugs/ vaccines for a novel pathogen in mere months’ time since the gene identification.

70%

of leading pharmaceutical executives (respondents of the survey) were optimistic that the industry will continue to grow over the next 12 months.

Source: GlobalData Survey

This optimism calls for a strategy that enables companies to –

  • get their supply chains back on track
  • optimize operations
  • effectively handle the shortage of workforce
  • leverage the latest technologies for accelerated production and overall better
  • create more personalized patient connections.

However, the path ahead is not without its set of challenges. After all, the pharmaceutical sector has been conventional in its outlook when it comes to newer technology adoption. There are also challenges related to budget, upskilling of employees, technological glitches and more. Companies need to gauge the path ahead and handle the challenges faced by pharmaceutical industry in 2020 and beyond.

Steps towards Transforming Pharmaceutical Strategies

1.Recognize Best Practices and Retain Them:The path to recovery is a tough one as it involves undergoing quite a metamorphosis. However, this does not entail letting go of all the practices. Pharma executives would need to analyze their operations and chalk down the practices, tools and technologies that have worked the best for them and also have the potential of harnessing benefits in the future. Continuing these practices will make restructuring in other facets of pharma operations a relatively smoother task.

2.Restructuring Assets for Process Streamlining: Be it the shop floor operations or inventory management or handling the entire supply chain– a new pharmaceutical strategy would be truly beneficial when pharma companies reassess and restructure their assets. This would fortify individual practices resulting in overall process optimization. It would also help to let go of stagnant and redundant technologies or practices to make way for more agile tools.

Figure: 1Pharmaceutical Strategies Breakdown: Towards the New Normal

Pharmaceutical Strategies Breakdown: Towards the New Normal

3.Adopting Digital Drivers of Change: The new normal is eventually going to be the only normal and thus pharmaceutical companies need to harness potential through digital tools and technologies. After retaining the best and letting go of the redundant, pharma operations would benefit greatly by using tools for Enterprise Resource Planning (ERP), Supply Chain Management (SCM), Customer Relationship Management (CRM), Artificial Intelligence (AI), Machine Learning, Big Data, Advanced Analytics etc. These tools and technologies would help in process automation, centralized data access, real-time supply chain monitoring and a lot more. Many pharma companies are looking at the digital revolution as their segue to pharma 2.0.

For instance, pharma giant Sanofi has already rebooted it’s digital strategy and is now ramping up operations in marketing, research and even e-commerce.

4.Moving from a Product-centric to a more Patient-centric Model:The healthcare sector is transforming and is becoming more personalized. With access to information and medical assistance becoming quite easy through smart devices, the consumers are highly aware of what they want. This is the pharmaceutical sector’s chance to connect with their end-users and know their requirements. The overall shift to become a patient-centric industry would take time and effort, but it is the right step. In fact, patient-centricity is already one of the key goals for many pharmaceutical companies, contract research organizations (CRO’s) and contract development and manufacturing organizations (CDMO’s). For example, the contract research organization, Parexel has hired its first-ever chief patient officer, with a focus on boosting clinical trial diversity for better results and ensuring that their drug is scalable to multiple demographics.

These points of considerations serve as the platform for companies to work on their renewed pharmaceutical strategies. Of course, every company has its unique set of operations, models and unique challenges. However, optimizing operations and leveraging digital technology to expedite growth are common must-haves for a pharmaceutical company’s renewed business approach. After all, the new normal will bring as many opportunities in the form of challenges and a well-equipped pharmaceutical company can harness the most out of its investments and talent-pool.

Key Takeaways

  • Even though the pharma sector has been slow to adapt to newer technologies, the dynamic changes in the past decade seemed to have enabled the industry to step up to the challenges posed by the Covid-19 pandemic.
  • A change in perspective is essential for success in the new normal and to rethink pharmaceutical strategies. Equally important is the communication of the perspective of this change from top management to employees.
  • Pharmaceutical companies would need to make use of the data being collected to generate insights and know exactly what their end-users need. Transforming to a more patient-centric business with the help of the right digital platform is the need of the hour.

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Importance of Data in Pharma Product Development
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Importance of Data & Analytics in Pharmaceutical Product Development
Importance of Data & Analytics in Pharmaceutical Product Development 700 500 Xcelpros Team

Introduction

Research and development (R&D) has always been the backbone of the pharmaceutical industry. In 2001, there were 1,198 pharmaceutical companies with active R&D pipelines. And in 2020, this figure spiked to 4,800. Due to the COVID-19 pandemic, companies have doubled their efforts in creating new products. In fact, more than 17,700 drugs were recorded in the global R&D pipeline in 2020—and a lot of them made headlines.

The world got a glimpse of how complex and costly it is to create new drugs. Moreover, that also sparked an unprecedented wave of data sharing and access not just in the healthcare and pharmaceutical industries. But in the IT sector as well. In fact, 96% of all companies will have hired a data specialist by 2022, according to “The Future of Jobs Report” by the World Economic Forum. This is why there has already been a huge uptick in the number of professionals pursuing data analytics careers, with worldwide big data revenue already predicted to have passed $203 billion.

In the pharmaceutical industry, multiple organizations came together to share and exchange data: Google Cloud provided researchers free access to critical information through its COVID-19 Public Dataset Program, and Rensselaer Polytechnic Institute offered government entities. And researchers access to innovative AI tools and experts in data and public health.

Figure: 1Role of Data in Pharmaceutical Product Development

Never before has data been so readily accessible and this has helped speed up the R&D efforts of many companies. In addition, data also helps the pharmaceutical products development in many other ways:

Improves research efficiency

Several companies were able to develop a COVID-19 vaccine in under a year—a record time—currently making it the fastest vaccine to ever be developed. It helped that pertinent data and information were exchanged freely between pharmaceutical companies, government agencies, and data analytics organizations.

Free-flowing data sharing, as seen during the pandemic response, makes the development of drugs easier as it cuts down several steps in the R&D process. And with the available information, researchers have a better understanding of the recipients of the product. This makes it possible for trials to acquire smaller sample sizes with higher accuracy, lower expenses, and in less time.

Creates precision medicine

Precision medicine is an approach to patient care that allows doctors to create diagnoses and treatments based on data on genetic make-up, environmental factors, and behavioral patterns. This approach allows companies to create personalized medicine for individuals’ genes and lifestyles. This data-driven approach also helps drug makers identify patients’ susceptibility to certain disorders, enhancing disorder detection. Since precision medicine has a higher probability of success compared to more conventional approaches, it also reduces trial costs.

One such example is Pfizer’s Xalkori (crizotinib), which they produced after combing through data from electronic medical records, clinical trials, and genomic data. They found that a small subset of lung cancer patients had a mutation in their ALK gene. And using this insight, they developed a personalized drug. “Had this compound been tested against a broad spectrum of lung cancer patients, it likely would not have been found to be effective. With this analytics-based approach, it was found to be very effective,” says Pfizer CIO Jeff Keisling.

Provides real-time analysis

It’s now possible to access real-time information—a feature that greatly benefits trials. With this, it’s easier to respond to issues in a timely manner, and create more accurate safety measures for trial participants, all leading to higher success rates from the R&D standpoint. Additionally, data can now be collected from real-world information such as health records, insurance claims, and even social media. This provides drug makers with evidence on how medicines work in an uncontrolled setting and across a wider demographic. This lets them make adjustments and improvements to the drugs.

Major pharmaceutical companies now have dedicated teams collecting data from studies and trials across different diseases. Their analysis of this information helps them formulate their drugs to be more potent and effective while combating the rising costs of traditional clinical trials and parallel development programs.

30%

of life science organizations will have achieved data excellence, or the concept of effectively using the right data at the right time, by 2022.

Source: IDC Health Insights prediction

Simplify production plans

After developing a product, it needs to be mass-produced and distributed. You need to know the appropriate targets for the best ROI. With the right data, companies are able to create a more solid production plan, reduce labor costs, eliminate waste, decrease the need for excessive inventories, and optimize equipment usage. This ease of production will only increase in the future both within the healthcare industry and companies connected to it. And with the pharmaceutical industry predicted to grow to $1.57 trillion in value, the role of data in streaming lining production processes will only increase.

Smoother supply chains

50%

of pharmaceutical and biotech companies will be using prescriptive data analytics with IoT data to optimize their supply chain.

Source: Worldwide Health Industry 2020 Predictions report

Today’s pharma companies are breaking away from traditional practices and are embracing digital transformation and pharmaceutical data analysis on a much bigger scale. This move allows them to understand and cater to the needs of both their customers and stakeholders. As we mentioned in our previous write-up on the ways to enhance customer experience. Using data analytics, you can improve your supply chain efficiency by easily validating data, detecting anomalies, benchmarking operations, and accessing mobile and logistic reports.

Moreover, data analytics for pharma development offers real-time route optimization and improved inventory management, freeing up man-hours which otherwise would’ve been spent tracking and monitoring business operations.

The use of data in developing pharmaceutical products is very beneficial. It helps prevent health issues and strengthen the patient care sector.

Article specially written for xcelpros.com By Nina Ross

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Role of electronic signatures in pharmaceutical quality control banner
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The Role of Electronic Signatures in Pharmaceutical Quality Control
The Role of Electronic Signatures in Pharmaceutical Quality Control 700 500 Xcelpros Team

Introduction

Many life-sciences companies struggle to ensure stakeholders’ revenue growth due to low performing, paper based systems. Furthermore, they deal with challenges related to operational efficiency, productivity, product quality, return on investments, and compliance-related issues. Another key challenge is managing humongous data in paper systems or disintegrated systems that are hard to access, analyze, and report. If any of these challenges ring a bell, your primary focus should be on redefining your current business proesses and standard operating procedures. Rapidly growing companies are quickly revisiting their business process and procedures as the industry is evolving. They are moving towards simple, agile and powerful electronic business management systems to stay ahead of competition. Your ability to grow the business is directly related to your openness to change.

A cross-functional pharmaceutical organization has departments such as Procurement, Receiving, Quality, Inventory, and Shipping that may be disjointed. Business processes tend to be more reactive when visibility of operations is low. Rapidly growing companies embrace a paperless environment to improve operational efficiency, cut down costs, meet regulatory standards, and, most importantly, maintain complete visibility. Switching to a system with electronic signatures can help cope up with evolving quality conditions, and make your company more relevant in the current market conditions.

Life sciences companies need digital systems to support their core business procedures and follow the right implementation practices to pass all computer systems validation requirements. Having electronic signatures embedded in their ERP system will be a major benefit to pharmaceutical companies. It provides the additional validation and visibility of authorized personnel who approve the movement or release of inventory after passing quality control.

Most modern pharmaceutical companies are moving towards electronic signatures to track their business activities. This eliminates manual circumvention of any activities or violation of procedures.

The global e-signature market is expected to grow at a CAGR of 34.7% during the forecast period, to reach $9,073.1 million by 2023.

The following are a few processes considered for computer systems validation:

  1. 1.Purchasing – Raw materials and packaging materials purchased from approved suppliers.
  2. 2.Receiving – Incoming inventory received with the right paperwork requires validation by a supervisor of the receiving department or a Quality manager.
  3. 3.Batch Production – While verification of raw materials consumption, operations, and yields.
  4. 4.Quality – This is an absolute requirement for inventory on hold, waiting for batch quality testing before releasing material for consumption or shipments.

Figure: 1 Electronic signature in Microsoft Dynamics 365 Finance and Operations – Production order release function

Electronic signature in Microsoft Dynamics 365 Finance and Operations

One of the primary FDA regulations called ‘Title 21 Code of Federal Regulations (CFR) Part 11’ states that “Persons may use electronic records instead of paper records or electronic signatures in place of traditional signatures, in whole or in part, provided that the requirements of this part met, and that a docket stating a company’s intent submitted to the FDA.

The transition from a paper-based quality management documentation to a comprehensive digital record system is not simple; it involves an array of challenges. Below are a few:

1.Poor Data Management: Data is a key component of a CFR 21 part 11 compliant system. Poorly managed and stored data can cause havoc when an auditor comes to your doorstep. How intuitive you want the Digital systems ultimately depends on how well the data is stored in the system. Information that is all over the place without a proper structure will only increase more audit and compliance issues. It is a good practice to conduct a periodic data review to ensure that all of the necessary steps are executed within different departments or when interacting with 3rd party systems.

2.Managing Digital Signatures With companies’ transitioning to digital systems, regulatory agencies have formulated several policies to safeguard electronic signatures. Poor document control is a significant reason for companies’ failure of regulatory audits. A ‘hard to audit’ digital system opens it up to more manual documentation changes by end-users. Companies need to have robust security control with hierarchical approval procedures to preserve electronic information and avoid regulatory penalties. It is hence imperative that your ERP system has the necessary infrastructure to manage electronic signatures at different steps. These acceptable electronic signatures can then easily be audited and reported.

3.Mitigating Quality Management Issues The purpose of implementing an electronic signature software is to grow collaboration across departments in your company, and not just in quality control. How your end users adapt to quality management processes plays a crucial role in realizing a software’s true potential. The digital system helps generate faster resolutions to pending requests by auto-reminding end users. Adopting good documentation practices in the pharmaceutical industry is essential to drive away quality management issues to make your company more stable, reliable and growth-oriented.

4.Changing Complacent Corporate Culture electing an intuitive, easy-to-use system and overall organizational change management are two critical parameters to ensure a swift transition to a digital system. It is essential to make end-users understand the workflow benefits of digital document management systems. If issues get ignored before the transition to a more compliant system, the legacy system’s inefficiencies will transfer over to the new system. Even though there could be initial resistance to switch to such a controlled system, the long-term benefits will outweigh the short-term user adaption issue. Being prepared and setting an expectation of what the change will be like and the type of issues to expect will be the first step to help users understand that the changeover may feel difficult at first but ultimately will help them be more successful.

Companies, therefore, require a digital system that demonstrates both regulatory and functional electronic signature compliance. A system that

  • helps in customizing levels of authentication
  • provides scalability and flexibility to customize workflows
  • supports bulk approval of all artifacts which are duly reviewed and signed off from a regulatory perspective
  • supports test management processes such as test plan, test lab, etc.
  • provides detailed audit trails for stakeholders and regulatory organizations.

Figure: 2Microsoft Dynamics 365 Finance and Operations – Quality control transaction with digital signatures

Microsoft Dynamics 365 Finance and Operations

Below are some common requirements for electronic signature within a Pharmaceutical ERP system:

  1. 1.The employee should have the appropriate security role in the system to create an electronic signature.
  2. 2.The employee has to be individually recognized by the system with their signature.
  3. 3.The employee should have a certificate on the system that is used to generate the electronic signature.
  4. 4.The signature should be able to detect if there were any susceptible violations.
  5. 5.If a signature violation occurs, it should be easily audited.

Electronic signatures can be possible with different levels of security, which allows you to verify a user, data and attest a signature on certain set processes. Only those individuals with access to view the transactions and have the ability to sign off electronically will be able to create the signature. The system will have a log to track the individual, the associated transaction event, date and time of the signature.

Microsoft Dynamics 365 Finance and Operations (F&O) is a CFR 21 Part 11 compliant system that gives you the ability to record an electronic signature on different Quality-driven transactions. F&O maintains the necessary audits of approvers authorized with a secure certificate from the system. The certificate provides you with an encrypted key using a password only accessible to the user. The system allows users only with the appropriate security credentials to access the transactions and once all the verification is done, lets the authorized personnel create a signature on the transaction.

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For more information on Prebuilt Electronic Signatures for your industry, contact us at contact@xcelpros.com.

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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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.
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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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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

Modern methods to best manage pharmaceutical quality control banner
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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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