Technical articles and regulatory perspectives on computer system validation, equipment qualification, and GxP compliance — written for practitioners who need to get it right.
ISPE released the second edition of GAMP 5 in 2022, introducing a more explicit risk-based framework and updated guidance on agile and cloud-based systems. This article outlines the key changes and their practical implications for validation programs in regulated pharmaceutical environments.
FDA's 2003 guidance narrowed the scope of Part 11 enforcement, but inspectors still cite electronic records and e-signature deficiencies regularly. This article covers the most common findings — audit trail gaps, access control weaknesses, and system validation deficiencies — and how to address them before an inspection.
Qualification protocols are only as strong as their acceptance criteria. Vague or untestable criteria are among the most common deficiencies cited in FDA 483 observations. This article covers the structural requirements for defensible IQ, OQ, and PQ protocols — including how to scope testing appropriately using risk assessment.
The Validation Master Plan is the foundational document for any validation program, yet it is frequently written too broadly to be useful or too narrowly to satisfy regulators. This article covers what a VMP must contain, how to scope it appropriately, and the most common structural errors that create compliance risk.
Cloud and SaaS systems present unique validation challenges: the vendor controls the infrastructure, updates happen outside your change control process, and traditional installation qualification may not apply. This article addresses how to scope and execute CSV for cloud-based GxP systems under current regulatory expectations.
When an FDA investigator arrives, your validation documentation needs to tell a coherent, complete story. This checklist covers the documents most commonly requested during GxP inspections — from the VMP and qualification protocols to change control records and periodic review documentation.
Note: Articles on this site reflect the professional perspective of Lee W Page Validation Associates LLC based on current regulatory guidance and industry practice. They are provided for informational purposes and do not constitute legal or regulatory advice. Regulatory requirements vary by jurisdiction, product type, and facility — consult qualified counsel for your specific situation.
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