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GMP, GCP and GDP Data Governance and Data Integrity – Version 3.0

The GMP, GCP and GDP Data Governance and Data Integrity Guide was developed by the experts of the ECA Analytical Quality Control and the Data Integrity & IT Compliance Working Group in close collaboration. Now, version 3.0 is available for download.

In addition to highlighting the “what”, the document also comprises about 40 pages of practical examples on “how” to implement the complicated data integrity requirements. It further includes an overview of the DI guidance documents available from other organisations and health regulatory bodies.

Version 3.0, which now comprises 96 pages, covers the critical area of the pharmaceutical laboratory and provides help for the implementation of

  • the control of blank forms,
  • manual integration of chromatography peaks,
  • hybrid systems,
  • spreadsheets,
  • management of contract laboratories
as well as for many other issues. Process Management and Manufacturing issues are described in a specific section with emphasis on the ISA 95 levels of MES applications, also stressing the review of audit trails in this area. The specific problems arising in GDP (Good Distribution Practice) – rarely covered in any DI guide – are highlighted as well. Finally, as regulators increasingly pay attention to the identification of CRO records in the Good Clinical Practice (GCP) section, it is also mentioned in various parts of the new version.

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