Introduction If you work in Quality, you’ve felt the tug-of-war between fixing something fast and fixing it for good. A mislabeled bottle is easy to reprint (correction), but the pattern of mislabels is a different beast that requires root-cause work (CAPA). Mixing these up clogs your system with either too many CAPAs or too many…
Introduction “Audit trail” and “audit log” are used interchangeably, but they’re not the same in regulated contexts. System logs are useful for admins; audit trails must stand up in quality and regulatory inspections. Here’s how to tell them apart and make yours review‑ready. What is an audit trail? A secure, immutable, time‑stamped record of who…
Introduction Teams often confuse electronic signatures (e‑sign) with digital signatures. In Part 11 contexts, you need to prove identity, intent, and linkage to the record. Cryptography can help—but it’s not always mandatory. Here’s the clear view. E‑sign in regulated environments An e‑sign is data in electronic form that a person adopts as their signature. In…
Introduction Calling everything a “deviation” or everything an “NCR” leads to noise, rework, and audit risk. Here’s how to choose the right path quickly and defensibly. Definitions Decision tree Examples Documentation essentials Typical pitfalls Metrics How an eQMS helps Conclusion Use deviation for process departures, NCR for out‑of‑spec results, and connect them via CAPA/change when…
Introduction Not every strange result is a failure. OOS needs containment and investigation; OOT needs statistical thinking and trend awareness. Overreacting either way burns time and credibility. Definitions Handling OOS (simplified) Handling OOT (simplified) Pitfalls Documentation How an eQMS helps AI Assist: compresses long analytical narratives into a clean executive summary Attachment control and versioned…
Introduction CAPA responds to a problem; Change Control manages planned change. Confusing the two doubles work and hides risk. Here’s how to route correctly. Core concepts When to raise which Linking them cleanly Good practice fields How an eQMS helps Conclusion Use CAPA to fix causes; use Change Control to manage intentional change. Link them,…
