computer system validation snags - FDA.COMs Community Forums

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Post: computer system validation snags

Anonymous

04-22-05 09:03 AM - Post#1702
In response to Anonymous

It all depends on the snags. If they are not life threatening as I am assuming from your description, you can continue with validation by doing two things:

1. Document all snags in the issues log including its disposition and or resolution. Attach the issues log with final compliance report.

2. Create the Modification requests and provide their dispositions along with any solution if there is any. Attach all modification request numbers with the final compliance report.

I hope it helps.

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