Medicines & Healthcare products Regulatory Agency (MHRA) GXP Data Integrity Guidance and Definitions
1. Background
The way regulatory data is generated has continued to evolve in line with the ongoing development of supporting technologies such as the increasing use of electronic data capture, automation of systems and use of remote technologies; and the increased complexity of supply chains and ways of working, for example, via third party service providers. Systems to support these ways of working can range from manual processes with paper records to the use of fully computerized systems. The main purpose of the regulatory requirements remains the same, i.e. having confidence in the quality and the integrity of the data generated (to ensure patient safety and quality of products) and being able to reconstruct activities.
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Table of contents
3. The principles of data
integrity
4. Establishing data
criticality and inherent integrity risk
5. Designing systems and
processes to assure data integrity; creating the ‘right environment’
6. Definition of terms and
interpretation of requirements
6.2. Raw data (synonymous with
‘source data’ which is defined in ICH GCP)
6.7. Recording and collection
of data
6.8. Data transfer / migration
6.10. Excluding Data (not
applicable to GPvP):
6.11. Original record and true
copy
6.12. Computerized system
transactions:
6.15. Data review and approval
6.16. Computerized system user
access / system administrator roles
6.19. Validation – for intended
purpose (GMP; See also Annex 11, 15)
MHRA GXP Data Integrity Guidance and Definitions
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