On the other hand, not all decisions concerning process validation vs process verification are that straightforward to make. Should you’re considering whether or not you need to validate or validate a process, then start with the IMDRF guidance on process validation.
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Consumer shall execute authorised SAT protocol and may check for all tests described in protocol Along with the QA & maintenance consultant at the location when item/ devices/ system reaches the manufacturing facility premises and documented by the manufacturing and engineer.
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