Blog
Laboratory QMS: ISO 17025 vs ISO 13485 — Which Standard Applies and When
Quality managers in regulated industries eventually hit the same question: the laboratory runs tests that feed into device submissions, pharmaceutical
Compounding Pharmacy QMS: USP Chapter 797, 795, and FDA Requirements
TLDR Compounding pharmacies operate under a quality framework that spans USP Chapter 797 (sterile compounding), USP Chapter 795 (nonsterile compounding),
Cell and Gene Therapy Quality System: FDA’s Framework for Advanced Therapy Manufacturing
TLDR Cell and gene therapy (CGT) manufacturers face one of the most complex quality system environments in regulated industry. FDA
Serialization and Track-and-Trace: Drug Supply Chain Security Act (DSCSA) and QMS Requirements
TLDR The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical manufacturers, repackagers, wholesalers, and dispensers to serialize prescription drug products
Real World Evidence (RWE) and Data Quality: What FDA’s Guidance Means for Your QMS
TLDR Real world evidence (RWE) is increasingly accepted by FDA to support regulatory decisions, including new indications, post-market surveillance, and
AI-Assisted Compliance: How Quality Teams Are Using Automation Without Triggering FDA Scrutiny
TLDR Quality teams in pharma, medical device, and biotech are adopting AI tools to automate deviation trending, document review, CAPA