EU GMP Annex 11 Explained: What You Need to Know About Computerised Systems Compliance Most organisations still think about GMP compliance mainly at go-live. But regulatory risk does not usually sit at go-live anymore. With the proposed revisions to Annex...
FDA Final Guidance on Computer Software Assurance (CSA): What It Means for Life Sciences On September 24, 2025, the U.S. Food and Drug Administration (FDA) issued its long-anticipated final guidance on Computer Software Assurance (CSA) for Production and Quality System...
EU GMP Annex 11 Explained: What You Need to Know About Computerised Systems Compliance Discover how Tech Qualitas helps pharmaceutical, and biotech companies stay ahead of the 2025 EU GMP Annex 11 update. From computerised systems compliance to validation and...
EU Opens Public Consultation on Revised GMP Guidelines The European Commission’s Directorate-General for Health and Food Safety has launched a public consultation on the revision of several Good Manufacturing Practice (GMP) guidelines. The consultation is open from 7 July 2025...
Beyond Functionality: Strategic Communication and Change Management for SaaS Vendors and Customers As more regulated organizations adopt SaaS platforms to manage their quality and compliance processes, one critical area that often gets overlooked is how changes in these platforms are communicated...
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