Configuration changes of s/w and Part 11 compliance

[v9991]

need quick guidance on the following issue!

background :
1. we have an workflow application, which is configurable.
eg., we can configure the requirement of e-sign for any given step just by setting the toggle key Y/N

2.we maintain the audit trail of the changes carried out in the configuration module.

3. and the above setup is validated during initial installation/implementation.[IQ-OQ-PQ]

query :
Now during the life cycle of the application, if i change the e-sign requirements for any specific step in the workflow using the configuration module;
1. will it be adequate to process it through "change control" along with appropriate revision of SOP/Training ?
or
2. do we need to re-validate the system?

my approach is that, since, the OQ & PQ covers the application, inclusive of configuration aspects; change control would be adequate.

thanks
valiveti.

[raghu_1968]

Dear Valiveti,

The following are my suggestions:

Suggestion -1: (Only change control)

If there are little changes, Go through ‘Change control’ procedure. Attach the evidence for the changes performed.

Apart from change control, write a memo for the changes,
Attach the photocopy of the change control and screen shots for the changes done;
Keep this as addendum of the qualification document.

Suggestion -2: (Fractional validation)

If it will affect the security settings,

• Raise the change control,
• Put a validation plan to address the deliverables
• perform the changes done, validate the security configuration and do the minimum performance check in the validation;
• Finaly write a summary report.

Regards / Raghu