Articles tagged with “eqms-software”

Pharma Complaint Management: FDA 21 CFR, EU GVP & CAPA

Review pharma product complaint management regulations, including FDA 21 CFR 211.198 and EU GVP. Analyze CAPA linkage, reporting requirements, and eQMS tools.

40 min read

5/17/2026

pharma complaint management 21 cfr 211.198 21 cfr 820.198 eu gvp capa process pharmacovigilance post-market surveillance eqms software quality assurance

Biotech QMS Strategy: Transitioning from Excel to eQMS

Examine the risks of DIY quality systems in biotech. Learn about FDA Part 11 compliance, data integrity, and when to transition from Excel to eQMS software.

45 min read

2/10/2026

biotech qms eqms software data integrity 21 cfr part 11 quality assurance regulatory compliance iso 13485 life sciences