7. Documentation

"What isn't written down doesn't exist": equipment qualification and the validation of associated IT systems must therefore be formally documented. Static and dynamic qualification documents specific to each piece of equipment are kept in logbooks, binders and electronic notebooks close to the equipment. They provide a basis for internal and external audits. Any change made to the equipment or software must be documented in an additional document, without removing the previous one.

Qualification documentation must include :

• uniquely identify the device and its modules;

• provide detailed protocols for qualification tests, acceptance criteria, standards and reference materials;

• indicate the frequency of testing, and the level of operator responsibility...