Requirements management - Is it necessary?

In the life sciences industry one basic starting point are requirements. Therefore, user requirements are collected and documented accordingly. This can be done by a list, with specific tools or a document like the URS (user requirements specification).

The first challenge is to focus on the functional, non-functional and technical requirements. The second challenge is to bring together the ?right specialists like SMEs (subject matter experts). The third challenge is to align all those collected requirements i.e. to identify duplicates even if the wording of the separate departments seems to be different. The fourth challenge is to track the requirements of the specification branch throughout the functional specification, design specification and so on. The fifth challenge is to ensure the full and correct coverage throughout the verification branch with tests and checks like developer tests, unit or module tests, installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) as acceptance testing. And accordingly, verifying back to the corresponding specification documentation.

For this reason, the requirements run like a common thread through whole project phase of the computerized system validation (CSV). For that a traceability matrix is beneficial. Not only for the specific project phase but for the whole life cycle of the computerized system. Because with the use of the computerized system and its related processes, requirements can change, become obsolete or added as new one. And this all need to be documented accordingly, especially within the regulated context.

A good requirements management is needed and it includes the traceability as well.

Heaven can wait.

But: Validation can’t wait!?

Do you have further questions to requirement management do not hesitate to contact us!