Digital Transformation

Lessons from 483 Inspections: CFR 21 Part 211

by | Mar 15, 2024 | , , , , , ,

In the highly regulated world of drug and biotechnology manufacturing, adhering to FDA regulations is essential not just legally, but also for protecting patient health, ensuring quality and building market trust. This blog highlights a critical trend: over 50% of the compliance issues noted during FDA Inspections (as documented in 483 Letters) for drug manufacturers (including some biotechnology firms) have focused on specific sections of FDA CFR 21 Part 211. This indicates a crucial area for compliance improvement to maintain operational integrity and uphold industry standards.  Understanding CFR 21 Part 211 and Recent Observations:  FDA CFR 21 part 211 outlines the regulations for the manufacturing, processing, packing, or holding of drug...

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Lessons from 483 Inspections: Navigating FDA Compliance for Drug and Biotech Manufacturers

by | Mar 14, 2024 | , , , , ,

In the biopharmaceutical industry, ensuring public health and product safety is paramount. Regular inspections by the Food and Drug Administration (FDA) are crucial to this mission. Even for established companies, the prospect of receiving a Form 483 (a document outlining potential compliance issues) following an inspection can be nerve-wracking.  Common Areas of Non-Compliance The FDA's Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) publish annual data on the number of 483s issued and aggregated data on the particular types of issues cited in the 483 letters. While each individual 483 letter is unique, looking at the data in aggregate reveals recurring themes, such as:  Quality systems: Deficiencies in quality...

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Enhancing Collaboration in Regulated Industries: The Cloud Advantage

by | Feb 8, 2024 | , , , , , ,

Collaboration is the cornerstone of success in today's fast-paced business world. This holds particularly true for regulated industries like medical devices and biopharma, where efficiency, compliance, and quality control are paramount. Cloud platforms, such as Microsoft Azure with Merit Life Science for Dynamics 365 have revolutionized collaboration by providing secure and compliant environments for data sharing and real-time decision-making. The ability to streamline approvals, enhance transparency, and reduce operational uncertainties not only benefits the organizations but also elevates the customer experience. Streamlined Approvals and Compliance Consider a scenario where a contract manufacturer (CDMO) needs customer approval to proceed with a critical production batch. The data...

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How Life Science CDMOs are Using Cloud Computing to Create Differentiation

by | Jan 25, 2024 | , , , , , , ,

Contract development and manufacturing organizations (CDMOs) are experiencing new entrants and capacity expansion, leading to the need to create and maintain differentiation in service offerings to stay competitive. With change comes opportunity, and the strategic implementation of digital infrastructure is crucial for staying competitive. In this blog, we'll explore four reasons why CDMOs are increasingly moving to cloud applications to run their enterprise business and the benefits of cloud applications.  Capacity Expansion Differentiation and Competition  People and Collaboration  Quality, Speed, and Confidence Capacity Expansion  Until recently, biopharma contract development and manufacturing faced a significant capacity shortage. Procuring contract development...

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Is Your ERP Holding You Back? Unleash Your Organization’s Innovation

by | Jan 11, 2024 | , , ,

You rely on your ERP system to support your life science business, but lately, you’re starting to question if it’s supporting you as effectively as it could. And you suspect that your ERP won’t be able support you in hypergrowth mode.   What are the warning signs that you’ve outgrown your current ERP system? As we’ve worked with biotech, pharma, and medical device manufacturing customers who are considering moving to a new ERP system, we've seen some familiar signals that affected their ability to reach the levels of growth and leadership they were seeking. Here are four signals that might be spotted in your organization, too. Four Warning Signs Your ERP is Holding You Back: Lack of flexibility Ineffective collaboration Lack of decision-making information Inaccurate data Get...

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Why ERP Implementations Fail (and How to Ensure Success)

by | Aug 8, 2023 | ,

Many of the biotech or pharma companies we work with start the relationship by asking why there is so much information out there on the high failure rate of ERP implementations? Why do we believe ERP implementation success rates are so low? Typically, the root cause of an ERP implementation failure falls into one of these categories: Point. Shoot. Aim. IT-driven Waiting room Enigma Point. Shoot. Aim. Refers to an approach in which the project charter is soft, or where the resource allocation is fluid, or where the ability to make the big decisions in a timely fashion is lacking. IT-driven. IT is a critical component of every ERP implementation, and often the IT leaders may have designed the first business solution the company used. Sometimes they’ve done so much work that the software...

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