Insights
Perspectives on compliance
Practical thinking on Computer System Validation, Data Integrity, and Regulatory Compliance — from practitioners who work in the field every day.
Latest
GAMP 5 Second Edition: What's changed and what it means for your validation programme
The second edition of GAMP 5 brings a sharper focus on risk-based thinking, critical thinking, and the role of supplier assurance. We break down the key changes and their practical implications for validation teams.
Read moreALCOA+ in practice: Moving beyond the acronym to a genuine data governance culture
Most organisations can recite ALCOA+. Far fewer have embedded it into their day-to-day operations. This article explores what genuine Data Integrity culture looks like — and how to build it.
Validating cloud and SaaS systems: Navigating shared responsibility in a GxP environment
Cloud-hosted systems present unique validation challenges. Understanding where supplier responsibility ends and your own begins is critical — and regulators are paying close attention.
MHRA inspection readiness: The five areas inspectors focus on most
Drawing on recent inspection experience, we outline the five areas where MHRA inspectors consistently find gaps — and what you can do to address them before they arrive.
Periodic Review: Compliance obligation or genuine quality tool?
Too many organisations treat Periodic Review as a tick-box exercise. Done well, it's one of the most valuable tools for maintaining validated status and identifying emerging risks.
Data Integrity remediation: Why quick fixes rarely stick
When Data Integrity issues are identified — whether internally or by a regulator — the temptation is to move fast. We explain why sustainable remediation requires a more considered approach.
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