Glossary
Annex 11
The EU GMP annex governing computerised systems. The European counterpart and complement to FDA's Part 11, broader in lifecycle scope.
Where Part 11 concentrates on electronic records and signatures, Annex 11 covers the whole life of a computerised system: supplier assessment, validation, data, accuracy checks, audit trails, security, incident management and periodic evaluation. It reads less like a records rule and more like a condensed validation handbook.
Companies operating globally usually build to both at once, since a system satisfying Annex 11's lifecycle expectations rarely struggles with Part 11's record controls. The reverse is not true, which is why Annex 11 tends to set the bar in multinational quality systems.
Related terms