PIC/S · Life Science & Pharma: GxP - CSV & Data Integrity
PIC/S PI 041-1: Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
Final Data Integrity · Guidance Last verified: not yet · Source last checked 3 Nov 2026
- Issued by
- PIC/S
- Category
- Data Integrity
- Sub Category
- Guidance
- Legal weight
- Guidance & Q&A
- Reuse
- Link only
Guidance written for inspectors on keeping data reliable in GMP and GDP work. Companies read it to see what inspectors look for.
How to read this page
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- Status comes from the latest dated event below, and each event links to its source.
- Lifecycle shows the steps so far, then any expected target. Targets are not facts.
- In plain English is our own summary, not the official text. Where we have read the document in detail, a fuller profile follows, with its context, scope, contents and key points.
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Lifecycle
Solid steps have happened. A dashed step is expected, and it is not a fact. Only dated steps in our record appear here.
- Final version published
In plain English
Inspectorate guidance on data management and integrity for paper, hybrid and electronic systems, including data governance, ALCOA+ and computerised system controls. No revision announced as of October 2026.
Summary drafted with AI assistance. Not yet reviewed by the SME Reviewer. Read the official text before acting.
Context and history
PI 041-1 is the PIC/S guidance on data management and integrity in GMP and GDP environments, published on 1 July 2021. It is one of the main international references on data integrity, and it is written for inspectors.
Who and what it applies to
Inspectors, and the GMP and GDP regulated companies they inspect. This site treats PIC/S as link-only.
What it contains
- Structure
- Covers data governance, risk, the data lifecycle, and specific controls for paper and computerised systems.
Key points
- It covers both GMP and GDP.
- Data governance sits at its centre.
- Read it with the MHRA, EMA and FDA documents on data integrity.
In practice
General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.
- Use it to test your data governance, since it shows what inspectors are trained to check.
Read from the source document on 1 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.
Change log
Key dated events only, not a complete history. Status after is the status once that event happened. Event kinds explained
| Date | Event | Status after | Source |
|---|---|---|---|
| 1 Jul 2021 | Final version published | Final | Source for Final version published |
Related
How other documents connect to this one. Links explained
- Related to MHRA GxP data integrity· Compare with MHRA GxP data integrity Unverified link
Official source
The official text always prevails over anything on this site.
Summary in our own words. See the official text from PIC/S.
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