ICH Q9(R1)
Quality risk management for pharmaceuticals. Scientific knowledge, patient protection and effort proportionate to risk.
Resources
Standards and guidance
References for risk management and regulated software. Confirm applicability with your quality team.
ISO 14971
Risk management for medical devices. Relevant to device work, not a general pharmaceutical software certification.
Computerised systems and records
Annex 11, 21 CFR Part 11 and GAMP 5 can inform the scope of a software project. They have different purposes and applicability.
How we approach quality requirements →