All the documents that are created under an organisation’s validation program have to be authored, reviewed, approved and authorised before they can be used.
The responsibilities of the individuals who perform these tasks, together with the meanings of their signatures when they sign a document, should be established in the master validation plan.
In addition, the MVP should establish who may perform these roles.
Generally, any member of staff who has the appropriate combination of knowledge, skills, education, training and experience can author a document.
The reviewer of a document should have at least been qualified to an equivalent level. Documents should be approved by the head of all operational units affected.
Senior Signature
It should be noted that the approval signature is the most senior technical signature on a document, and it will be these individuals who will be interviewed, (e.g. by auditors) should clarification be needed in the future.
The authorisation of a document is performed by the Quality Assurance department, and this should be the final signature added to a document. The master validation plan should also establish when a document should be signed.
Related: Want to learn more about Master Validation Plans (MVP’s)
Test Documents (Validation Protocols, User Acceptance Testing, FAT, SAT’s etc)
A document such as a protocol, which provides instructions on how to perform certain tasks, or what tasks are to be performed such as testing, would normally be signed by the author, be reviewed, approved and authorised for use prior to execution; and after all the tasks in the protocol have been completed the document should be carefully reviewed, approved and authorised.
Design Documents (URS, FSD, SRS, RTM, Reports etc.)
A document that only captures information to demonstrate compliance such as a report will only need to go through the review, approval and authorisation process once, after completion.
Wet Signatures
Wet signature is the term that is used to describe when a document gets approved using a handwritten signatures with a pen (usually blue or black). In this scenario the paper document is sent or walked around to the responsibility individuals to seek their approval before the document can be approved.
It is a good idea in this scenario to ensure that the document is fully reviewed by all parties beforehand or else you could end up back at your desk printing new versions of the documents with minor changes.
Electronic Signatures
If your organisation uses a computerized signature that applies 21 CFR Part 11 signatures such as Kneat’s Electronic Validation Solution then the process of approving the validation documents becomes much easier and removes all of the inefficiencies surrounding this process.
