PIC/S PI 041
PIC/S PI 041 — Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments · pic/s data integrity · pi 041 guidance
PIC/S inspectorate guidance harmonising data-integrity expectations for GMP and GDP across more than 50 participating authorities.
PIC/S PI 041 is the inspectors' field guide for data integrity in GMP and GDP. It expands ALCOA+, defines computerised-system DI risk categories, and gives detailed expectations for audit trail review, blank-form control, user access management, and outsourced/contracted DI responsibilities.
V5 maps each PI 041 risk category to concrete controls — segregated duties, periodic audit-trail review, automated DI alerts — so inspections from any PIC/S member find the same enforced model.
- PIC/S PI 041-1 (Jul 2021)
Try V5 free for 7 days with no card needed, or talk to our team about what applies to your operation.