Validation Documents Revision


I have a query regarding revision of validation documents. We have a very well established IT SOPs in our organization, but I feel sometime that it needs some updates. I required your help and recommendation in understanding the documents revision.

Whenever there is a change control raised for making some configuration changes in the existing state of the application/software, do we really require to update the Configuration Specification or design specification every time when there is a update in the configuration to document it? E.g, Updating the CS document even for a group creation in the user roles, we need to update the CS document. Again after few months, if it is required to change the privilege of certain user group roles, CS will be revised. This means multiple times the same document is being revised with the revision history in the document.

Can’t we keep the initial document (Which was created during the first time implementation of the application) as a baseline document and don’t update it for further CC. Will it be a good idea to document all further changes in the CCR (Trackwise or manual) and a script based verification is performed to have the documented evidence of the change? Actually authors get annoyed of revising the same document again and again and I really have don’t a satisfactory answer for them.

Kindly suggest, which one is the acceptable practice and which one can be best suitable to the agencies/auditors to have a look on it. Or in other way, how they look into this.

Warm Regards,

Probably need more information to help.

What, specifically, is in your Configuration Specification document?

Why does the configuration change? Can you list some examples?

Your statement about changing the privileges of certain user group roles is a bit unsettling. That doesn’t sound like a good practice irrespective of the documentation aspect.