Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
The PIC/S data integrity guidance (adopted 1 July 2021), written for inspectorates — which makes it the closest public view of how data integrity is actually inspected. Covers data governance, paper-based and computerised systems, hybrid situations, outsourced activities, and how deficiencies should be classified and remediated.
GMP and GDP environments inspected by PIC/S participating authorities. Structured as inspection guidance, so each section pairs expectations with the way an inspector should probe them.
The nine attributes PIC/S PI 041-1 expects of GMP/GDP data, whether paper or electronic.
- ✓Attributable — who recorded the data or performed the action, and when
- ✓Legible — readable and permanent for the record’s entire lifecycle
- ✓Contemporaneous — recorded at the time the work is performed
- ✓Original — the first capture, or a verified true copy of it
- ✓Accurate — correct, truthful, complete, valid and reliable
- ✓Complete — all data, including any repeats, reanalyses or reprocessing
- ✓Consistent — sequenced and date/time-stamped in the expected order
- ✓Enduring — recorded on controlled, durable media — not scrap paper
- ✓Available — retrievable for review and inspection throughout the retention period
PI 041-1 is written for inspectors, so it also expects data-integrity risk to be governed proportionately to data criticality, and deficiencies to be classified and remediated.
Source: PIC/S PI 041-1, Good Practices for Data Management and Integrity. Verify against the current text before relying on it for a submission.
- 01Implement a documented data governance system with clear management ownership
- 02Apply risk-based controls across paper, electronic, and hybrid records
- 03Control user access, privileges, and audit trails in computerised systems
- 04Extend data integrity expectations to outsourced activities and suppliers
- 05Classify and remediate data integrity deficiencies with a risk-based methodology
PI 041-1 was adopted 1 July 2021 after several draft rounds. It consolidates the PIC/S position alongside the MHRA (2018) and WHO data integrity guidances and is referenced by many national inspectorates.
PIC/S PI 041-1: frequently asked questions
Quick answers to common questions about PIC/S PI 041-1.
What is PIC/S PI 041-1?
PIC/S PI 041-1 — Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments — is a guidance issued by the Pharmaceutical Inspection Co-operation Scheme. The PIC/S data integrity guidance (adopted 1 July 2021), written for inspectorates — which makes it the closest public view of how data integrity is actually inspected. Covers data governance, paper-based and computerised systems, hybrid situations, outsourced activities, and how deficiencies should be classified and remediated.
Who does PIC/S PI 041-1 apply to?
GMP and GDP environments inspected by PIC/S participating authorities. Structured as inspection guidance, so each section pairs expectations with the way an inspector should probe them.
What are the key requirements of PIC/S PI 041-1?
PIC/S PI 041-1 requires, among other things: Implement a documented data governance system with clear management ownership; Apply risk-based controls across paper, electronic, and hybrid records; Control user access, privileges, and audit trails in computerised systems; Extend data integrity expectations to outsourced activities and suppliers.
When was PIC/S PI 041-1 last updated?
The current version of PIC/S PI 041-1 dates from July 2021. PI 041-1 was adopted 1 July 2021 after several draft rounds. It consolidates the PIC/S position alongside the MHRA (2018) and WHO data integrity guidances and is referenced by many national inspectorates.
Ready-to-use templates designed to help you comply with PIC/S PI 041-1.
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