T. J. Kuhn | GxP Zone

Good Practice for the Pharmaceutical Industry from the Quality Assurance Perspective

WHO: GOOD DATA AND RECORD MANAGEMENT PRACTICES

Posted by tjkuhn on February 22, 2016

Some good stuff in this guidance….particularly the bit on True copies…..

GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES (SEPTEMBER 2015) DRAFT FOR COMMENT

True copy: A true copy is a copy of an original recording of data that has been certified to confirm it is an exact and complete copy that preserves the entire content and meaning of the original record, including in the case of electronic data, all metadata and the original record format as appropriate.

Full Guidance:  http://www.who.int/medicines/areas/quality_safety/quality_assurance/Guidance-on-good-data-management-practices_QAS15-624_16092015.pdf

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