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QCLYNX partners with life sciences organizations to deliver practical, risk-based solutions across GxP compliance, computerized system validation, quality assurance, and technology.

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QC reviewer pointing at a flagged entry in a computerized system audit trail during a regulatory audit

How to Survive a Regulatory Audit: 5…

Quick answer: Audit trail compliance means more than switching the audit trail on. Under 21 CFR 11.10(e) and EU…
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21 CFR Part 11 Compliance Gaps: 10 Audit Failures & Fixes

21 CFR Part 11 Compliance Gaps: 10…

Navigating FDA Title 21 CFR Part 11 compliance remains a high-stakes priority for pharmaceutical, biotechnology, and medical device organizations.…
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Data Integrity in Pharma: From ALCOA+ to Practical Controls

Data Integrity in Pharma: From ALCOA+ to…

Data integrity remains at the forefront of global regulatory inspections. Health authorities—including the US FDA, EMA, Health Canada, and…
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The U.S. Food and Drug Administration (FDA) updated its Computer Software Assurance (CSA) guidance on February 3, 2026

FDA CSA Guidance 2026: What Changed for…

 The U.S. Food and Drug Administration (FDA) updated its Computer Software Assurance (CSA) guidance on February 3, 2026, to…
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