Network server validation - Record Retention

I am looking to move away from keeping hard copy files of policies, procedures, and forms by using a network server. My plan is to store documents within a folder in the the server. My question is does this need to be validated? Thanks.

 

Part 11 just says:

(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

So you do need to ensure whatever you set up does still meet the requirements.

While there may not be an application to validate, it would at least be a good idea to walk through the requirements and describe how each is met. There may be some validation work in there to properly demonstrate. For example, how would you show:

(e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.

 

I think it 'll be good if you do an FMEA and describe how do you control who has access to change and edit files inside this folder, use strong passoword in your server and document the procedures of backup and the visibility that you have if someone changes something....