EU GMP Annex 11: Computerised Systems in Cannabis QMS

Electronic batch records and validated software are now inspection targets. What Annex 11 expects from cannabis manufacturers.

Context and Why It Matters

The regulatory environment for medical cannabis moves faster than most commercial cycles. Staying current is an operating condition.

Evidence and Current Practice

National authorities slowly converge toward common frameworks, but practical differences between jurisdictions remain significant.

Operational Considerations

Local interpretation of international standards (EU GMP, ICH, WHO) varies. Anticipating the regulator's reading reduces surprises during inspections and filings.

Bottom Line

Documentary traceability is the common answer to nearly every regulatory requirement.