PIC/S PI 011-3: Good Practices for Computerised Systems in Regulated GxP Environments

Context and history

PI 011-3 is PIC/S guidance on computerised systems, written for inspectors. PIC/S adopted it in June 2003, and it entered into force on 1 September 2003. This version is dated 25 September 2007. It has aged, but it remains the most detailed PIC/S document on the subject, and many companies read it to see what inspectors are trained to look for.

The PIC/S GMP Guide and its Annex 11 remain the basis for inspections. This document gives recommendations and background to support them.

Who and what it applies to

Good practice inspectors, for training and for inspecting computerised systems in the regulated pharmaceutical sector. PIC/S notes it may help companies under other frameworks, and that national legislation decides how far it applies.

This site treats PIC/S as link-only, so this profile describes the document's scope and structure and does not reproduce its text.

What it contains

Part one: Preamble

Document history, purpose, scope and introduction.

Part two: Implementation of system

Implementing systems, their structure and functions, planning and life-cycle management, management and responsibilities, user requirements, functional specifications, suppliers and developers, QMS and software standards, testing, validation strategies, a software category approach, and retrospective validation.

Part three: System operation, inspection and references

Change management, change control and error reporting, security and back-up, data changes and audit trails, electronic records and signatures, personnel, inspection considerations, checklists and aide memoires, references, reading, a glossary and abbreviations.

Key points

• It supports Annex 11 inspections, and does not replace the GMP Guide.
• It covers a system's whole life, from planning to operation.
• It contains inspection considerations and checklists.
• Read the official document for its detail. We do not reproduce it.

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 its structure as a checklist when preparing for an inspection.
• Remember its age: check whether newer guidance has moved on.

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.