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Frederic Landry
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Join date: Jul 22, 2020
Posts (15)
Feb 10, 2026 ∙ 2 min
Is it mandatory to classify User Acceptance Tests (UATs) as raw data?
Is it mandatory to classify UAT records as raw data in pharma and biotech? Discover why executed UAT evidence may not be reconstructible and why raw data–like controls improve validation traceability and inspection readiness.
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Aug 11, 2025 ∙ 4 min
A Practical Framework for Risk-Based Procurement of GxP Software and Technology Services
Selecting GxP software isn’t just about features—it’s about trust, compliance, and risk. This practical framework helps life sciences organizations evaluate supplier quality, system risk, and validation needs using a structured, risk-based approach to ensure regulatory alignment and business continuity
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Apr 8, 2025 ∙ 3 min
Right-Sizing GMP Compliance: Balancing Efficiency, Risk-Based Quality, and Regulatory Expectations in Life Sciences
Rethink GMP: Cut complexity, not quality. Focus on efficient systems that truly improve product quality and patient safety.
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