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E-mail from non-validated or unsecured devices really should not be utilized as the primary document exactly where a hardcopy is needed.Primary documents (Excellent Documentation Techniques) shall be saved Using the batch documentation and archived because of the respective documentation cell.The necessities of the tests shall be covered by a speci

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Reviewers/Approvers may well delegate authority to a different suitably skilled person to evaluate/approve information, as applicable.It's important to tell apart between the concepts of documents and information. Documents, in the GMP setting, seek advice from the how-to Guidelines that define what should be performed to produce the item or functi

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