MHRA GXP Data Integrity Guidance and Definitions

Sathyanarayana M.Sc.

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

1. Background

2. Introduction

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

6.1. Data

6.2. Raw data (synonymous with ‘source data’ which is defined in ICH GCP)

6.3. Metadata

6.4. Data Integrity

6.5. Data Governance

6.6. Data Lifecycle

6.7. Recording and collection of data

6.8. Data transfer / migration

6.9. Data Processing

6.10. Excluding Data (not applicable to GPvP):

6.11. Original record and true copy

6. 11.1. Original record

6.11.2. True copy

6.12. Computerized system transactions:

6.13. Audit Trail

6.14. Electronic signatures

6.15. Data review and approval

6.16. Computerized system user access / system administrator roles 

6.17. Data retention

6.17.1. Archive

6.17.2. Backup

6.18. File structure

6.19. Validation – for intended purpose (GMP; See also Annex 11, 15)

6.20. IT Suppliers and Service Providers (including Cloud providers and virtual service/platforms (also referred to as software as a service SaaS/platform as a service (PaaS) / infrastructure as a service (IaaS))

7. Glossary

8. References

MHRA GXP Data Integrity Guidance and Definitions:


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