Digital Transformation

Why true Cloud ERPs beat traditional ERP for Biopharma Compliance

by | Feb 19, 2026 | ,

Private cloud ERP might feel safer, but SaaS ERP offers a better compliance model for biopharma by reducing validation overhead, cutting costs, and enabling continuous compliance and innovation. SaaS ERP vs Private Cloud: A Better Compliance Model for Biopharma Life sciences companies use enterprise resource planning (ERP) systems to manage complex business processes and optimize operations for growth and efficiency. Governed by stringent regulations, life science manufacturers must maintain tight control over the entire manufacturing process from raw materials through distribution to ensure quality control across the product lifecycle. They must also be able to track product...

read more

AI in Regulated Manufacturing: Beyond the Hype to Real-World Implementation 

by | Feb 10, 2026 | , , , , , , , ,

The artificial intelligence conversation has reached a fever pitch across industries, and life science manufacturing is no exception. For GMP-regulated manufacturers operating under FDA, EMA, and MHRA oversight, however, the path to AI adoption looks fundamentally different than what you're reading about in mainstream tech headlines.  The work ahead is clear: helping our customers leverage this new capability in ways that improve product quality, enhance customer experience, and drive operational efficiency across their organizations.  The Reality Check: Not All AI Models Are Created Equal  The ability to leverage AI will likely prove more impactful than even most people realize. The capability to transform...

read more

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...

read more

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...

read more

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...

read more

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...

read more