#2 Who's afraid of Annex 11?

The Annex 11 document defines the #GMP requirements for computerized systems and forms part of the European quality-management regulations for the pharmaceutical industry. These are mandatory regulatory requirements that every EU-based manufacturer must comply with.

Although the document is relatively short, it’s divided into three key sections:

1️⃣ General – Right from the start, the regulator emphasizes the obligation to understand the risks associated with managing a computerized system throughout its entire lifecycle, to ensure proper team management, and — in my view — to nurture a strong organizational culture. There’s also an explicit focus on supplier management. In other words, the connection between lifecycle management, internal culture, and external partnerships forms the first cornerstone of Annex 11 compliance.

2️⃣ Validation Project – Validation isn’t just documentation or a checklist — it’s a project with a defined beginning, middle, and end, requiring proper planning, evidence, and traceability.

3️⃣ Operation – And then comes the reminder: completing the validation is just the beginning. Do you know how to operate, control, and maintain the system throughout its lifecycle? This section addresses exactly those long-term control mechanisms — such as access management, change control, backups, and yes, that sometimes-missing audit trail.

So next time someone asks you:

“Is the system validated?”

remember — the answer isn’t just about the project. And if they ask:

“Does it comply with Annex 11?”

you should be able to confidently say: Yes — because we manage it properly, not just validate it.