Hi,
Do we have to revalidate a software (eg. Waters Empower) after adding additional disk space such as an external hard drive?
Are there any guidelines for revalidation in such a case?
Thank you
You’re expected to take a risk-based approach to your decision as to whether to re-validate (and if so, how much). You’ve made a change so you NEED to assess the state of validation as a result. Will the change likely have any adverse effects on the system? In your case, likely not so you may be able to just write a “memo to the validation file” explaining your rationale and concluding that no additional re-validation effort is warranted. (Conversely, if you conclude that there is some risk with adding the additional disk space then you would determine what of the existing validation needs to be re-done / new testing to be done).
Of course, you SHOULD do all this assessment BEFORE you deploy the additional disk space.