Technology

EU GMP Annex 22: The New AI Regulatory Standard for Biopharma & Medical Device Manufacturing

by | Nov 26, 2025 | , , , , , , ,

As AI transforms biopharmaceutical and medical device manufacturing, regulatory bodies are establishing clear guardrails. EU GMP Annex 22 represents the most significant development in AI regulation for our industry to date. Merit Solutions CEO Bill Burke breaks down the critical requirements, validation expectations, and preparation steps manufacturers should take now. This article was originally shared on LinkedIn and is republished here for our community. EU GMP Annex 22: The New AI Regulatory Standard for Biopharma and Medical Device Manufacturing The European Commission has taken a decisive step in defining the regulatory future of AI in biopharmaceutical and medical device manufacturing. On July 7, 2025, it released the draft EU GMP Annex 22: Artificial Intelligence—a six-page...

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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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Merit Solutions helps growing life science companies make the Right Start 

by | May 2, 2022 | , , , ,

Pre-configured ERP offering provides customers an affordable point of entry without compromising on the long-term requirements of cloud, security, compliance, scalability, and industry-leading functionality.   “Ensuring customers can start with their last ERP solution first, means not having to handcuff growth because their system doesn’t keep up with their scientific success.”  Tanja Pajic, VP of Services, Merit Solutions Merit Solutions Right Start is Microsoft Dynamics 365, Merit for Life Science, and Microsoft Azure in a single deployment, natively integrated within a secure cloud platform. Merit Solutions announced today the availability of Merit for Life Science Right Start. Designed as an embed solution to Microsoft Dynamics 365, the solution includes the financial...

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The Microsoft Cloud for Biotech and Pharma Manufacturers Just Got Better

by | Jul 16, 2021 | , , , , ,

Merit for Life Science just became more powerful because Microsoft today announced a new level of integration coming between Dynamics 365 (D365) and Teams. This includes Teams integration with Dynamics 365 sales, marketing, customer service, and field service workloads with operations to follow. Microsoft is essentially saying, “Use Teams as your front-end app for work, with everything else operating as a context-intelligent side pane within Teams.”  Merit for Life Science advances Microsoft's base business and productivity apps to fit the unique needs of pharma and biotech, so this announcement is especially powerful for our industry and our customers.  Multi-step Processes Get Mainstreamed Why?  In biotech, our customer acquisition process tends to be multi-step,...

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Low Code/No Code: In Life Sciences, Extend Carefully

by | May 25, 2021 | , , , ,

The old joke is that you can do anything with software if you have enough money. With an army of programmers, it was basically true. But now there is a new way to develop software quickly and with much lower investment: low code/no code programming, a.k.a. codeless app development. Essentially, modern digital platforms have created visual building blocks that can be assembled according to user experiences designed by “citizen developers,” a term coined to describe these non-traditional programmers. Imagine building applications or extending functionality without ever writing a line of code!    Microsoft Azure and Power Platform Tools Microsoft has a deep execution of this development approach in Azure with their Power Platform tools. Canvas apps are "no code," and model-driven...

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