6-Tips for composing Better Validation Documents: Protocols
- Have detailed Specifications.
In validation documents, documents related Specifications are most technical hence it should be written in sufficiently clear and logical manner
- Drafting clear protocols.
We know that protocols, is the very first step for execution of validation, hence great importance and time should be dedicated in drafting a clear protocol. However, if we expect a particular protocol to be executed numerously, consequently greater amount of time is spent to make them more efficient and effective.
- Reduce grammatical errors and avoid ambiguous language in drafting protocols.
While drafting protocols proper attention should be given to grammar and style. Grammatical errors should be avoided, before published the document should be thoroughly reviewed.
- Reduce cumbersome and complex procedures.
Ideally, every procedures should be less than 5 sentences. Smaller sentences increases readability and hence increases comprehensibility of written procedures.
- Open comments policy
Organization should have open comments policy, so that staff members can ask questions and provide their feedback which can improve the efficiency of protocols used.
- Objective of Protocols
The prime objectives of protocols should be clear. Any layman especially invigilators/auditors reading the protocol document should be able to understand the purpose and objectives.(updated on 5.10.2020)