After MHRA and WHO have drafted their guidance documents on Data Integrity the US-FDA has published in April 2016 the Guidance for Industry for CGMP compliance (DRAFT Version).
The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practices. The guidance outlines US-FDA’s current thinking regarding the narrow scope and application of part 11 pending FDA’s reexamination of part 11 for 2003 as it applies to all FDA-regulated products.
Further reading / references:
- MHRA data integrity definitions (March 2015)
- WHO Guidance on Good Data and Record Management (Draft – September 2015)
Download at PDA the free code of conduct document for data integrity: Open External Link
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