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ala26 replied to the topic a successful validation process in the forum Introduction to Design Controls 6 years, 5 months ago
I recently finished an internship with a medical device company and two of my projects involved drafting a validation. I have a few advices to successfully complete a validation.
1. Try to draft it asap and e-mail all the people you need approval from. This process takes so long since people can take awhile to get back to you.
2. Check for previous validations. For the most part another location may have the machine you are validating. Ask to see their validation so you can use it as a template.
3. Draft the protocol. Start to collect the amount of parts needed for the protocol.