having dome some work on risk-based-auditing (sharing the audit reports across agencies ); agencies are now preparing the ground for 'quality metrics'.
and that preparation seems to be with focus on 'data quality and data integrity' ; anyways for the metrics to work, the data reliability is crucial.

FDA :- Data Integrity and Compliance With CGMP
WHO :- GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES
MHRA :- MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015
PDA :- Data Integrity
Elements of a Code of Conduct for Data Integrity in the Pharmaceutical Industry
and that preparation seems to be with focus on 'data quality and data integrity' ; anyways for the metrics to work, the data reliability is crucial.


FDA :- Data Integrity and Compliance With CGMP
WHO :- GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES
MHRA :- MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015
PDA :- Data Integrity
Elements of a Code of Conduct for Data Integrity in the Pharmaceutical Industry
Attachments
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Data Integrity and Compliance with cGMPs - US FDA.doc561.7 KB · Views: 201
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Guidance-on-good-data-management-practices_QAS15-624_16092015.pdf924.3 KB · Views: 208
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data-integrity-code-of-conduct.docx50.9 KB · Views: 317
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Data_integrity_definitions_and_expectations_v3_4__ackMHRA-jan 2015.doc1.7 MB · Views: 181
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