Blog
Audit Trail Review Procedures: What FDA Expects and How to Build a Compliant Process
Why audit trail review is a recurring FDA inspection finding FDA inspectors consistently cite audit trail deficiencies as some of
Risk-Based Approach to Computer System Validation: Applying FDA’s CSA Framework in Practice
For decades, pharmaceutical and medical device companies validated computer systems using a documentation-heavy approach rooted in traditional IQ/OQ/PQ protocols. For
21 CFR Part 11 Compliance Checklist: Electronic Records and Electronic Signatures
21 CFR Part 11 is the FDA regulation that defines the conditions under which electronic records and electronic signatures are
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
Continuous Manufacturing QMS: FDA Guidance and Quality System Considerations
TLDR Continuous manufacturing (CM) produces pharmaceutical product in an uninterrupted stream rather than in discrete batches. FDA has issued guidance