The PIC/S GMP Guide PE 009 for computerised systems, explained for IT
What the PIC/S GMP Guide asks of computerised systems, documentation, outsourced IT services and qualification, for sites inspected by a PIC/S participating authority.
One guide, many authorities
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) brings together GMP inspectorates from many countries. Its GMP Guide, PE 009, is the common text they inspect against; each authority adopts it in its own way. The version in the package is PE 009-18, in force since 24 September 2026.
What concerns IT
Four parts of the guide decide how computerised systems are run.
- Annex 11, computerised systems: risk management, suppliers, validation, data, audit trails, security, change and configuration management, periodic evaluation, incidents, business continuity and archiving
- Chapter 4, documentation: records in any form, including electronic, controlled, attributable and retained
- Chapter 7, outsourced activities: written agreements and oversight for hosting, software as a service and IT support
- Annex 15, qualification: IT infrastructure and systems qualified for their purpose and kept so through change control
National additions
Some authorities publish their own guides around the PIC/S text, with national terms and requirements. The package carries those it has written from the official source, and uses them only where you have chosen that authority.
With the GxP Validation Assistant
How the assistant covers it
Every rule, in its own words
PE 009's IT-related parts as a rule pack, each rule citing its clause, labelled guidance.
Your authority chosen
Rules limited to an inspecting authority are used only when you choose it, and the documents name it.
The operating records
Change control, incidents and CAPA, periodic and access reviews, backups, restore and DR tests, with reminders when they are due.
Self-assessment
A self-assessment round goes through the rules for your department and shows where evidence is missing.
Rule texts are summaries in the product's own words with their sources; PIC/S publishes the guide itself. Its binding force depends on your inspecting authority.
See it with your own systems.
Watch the webinar, or install the assistant and try it for 14 days.