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

by Bill Burke | Nov 26, 2025

EU GMP Annex 22 establishes the first comprehensive AI regulatory framework for pharmaceutical manufacturing. Learn the critical compliance requirements and how to prepare for 2027-2028 enforcement.

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

by Bill Burke | 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...

Is Your Data Estate Maximizing its Property Value?

by Bill Burke | May 18, 2021

When I hear biotech and pharma executives talk about their company’s “data estate,” I know the Microsoft and Amazon people have been meeting with them. I also think of the little British man who ran the estate on Magnum PI. His shtick was to be intimidating because...

Cloud computing: A smart move for FDA-regulated businesses?

by Bill Burke | May 11, 2021

As recent as five years ago, biotech and pharmaceutical companies were apprehensive about operating FDA-regulated business applications - like finance and operations - in the cloud. The concept of SAAS ERP or cloud computing was not only daunting, but it also raised a...

5 Considerations for Getting to a Validated, Cloud-based ERP Solution

by Merit Solutions | Mar 30, 2021

If you produce products in pharmaceuticals, nutraceuticals, or biotechnology, your organization must maintain system validation. The FDA defines this as: “establishing documented evidence that provides a high degree of assurance that a specific will consistently...