GAMP Guide: Records & Data Integrity

GAMP

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Published: March 2017
Pages: 152

Table of Contents
Special Pricing for Emerging Economies

The ISPE GAMP^® Guide: Records and Data Integrity provides principles and practical guidance on meeting current expectations for the management of GxP regulated records and data, ensuring that they are complete, consistent, secure, accurate, and available throughout their life cycle.

This Guide is intended as a stand-alone ISPE GAMP^® Guide aligned with the ISPE GAMP^® 5: A Risk-Based Approach to Compliant GxP Computerized Systems. It has been designed so that it may be used in parallel with guidance provided in ISPE GAMP^® 5 and other ISPE GAMP^® Good Practice Guides. Although the scope of this document is wider, it replaces the previous ISPE GAMP^® Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures.

This Guide has been developed by ISPE's GAMP^® Community of Practice (CoP), a world-wide community of practitioners and subject matter experts who have been developing internationally accepted guidance on risk-based approaches to safeguard patient safety, product quality, and data integrity for more than twenty-five years.

This Guide has been produced with significant input and review from regulators worldwide, including key specialists from leading regulatory authorities such as MHRA and WHO, that work in this area.

The Guide is intended to be a complete and comprehensive single point of reference covering the requirements, expectations, and principles of pharmaceutical data integrity. Topics covered include regulatory focus areas, the data governance framework, the data life cycle, culture and human factors, and the application of Quality Risk Management (QRM) to data integrity. As such, it is of great interest to anyone with a responsibility for ensuring data integrity, including:

Executives and managers
Process and data owners and data stewards
Technical system owners
System developers, maintainers, and users
Quality Assurance and Quality Control
Clinical, manufacturing, and laboratory personnel
Validation and compliance specialists
Suppliers of systems and services
IT and engineering professionals

Readers will gain an invaluable insight into the pressing hot topic of pharmaceutical data integrity, an in-depth understanding of the key requirements and principles, and an awareness of practical approaches and techniques to effectively address data integrity challenges. The Guide will help regulated companies and their suppliers to achieve the high level of data integrity expected by regulatory authorities worldwide.

Key benefits of the ISPE GAMP® Guide: Records and Data Integrity:

Data integrity requirements, critical areas of regulatory focus and concern, and key concepts
Framework for data governance and the importance of human factors
Complete data life cycle approach as part of a Quality Management System (QMS), from creation to destruction
Further information on how to apply the Quality Risk Management (QRM) approach from ISPE GAMP® 5 to record and data integrity
More detailed information, including “how to” guidance for specific topics, in a series of management, development, and operation appendices

Below is a detailed comparison of the content in the ISPE GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures compared to the new replacement guide, ISPE GAMP Guide: Records and Data Integrity:

	Electronic Records and Signatures Good Practice Guide Section/Topics	Records and Data Integrity GAMP Guide Mapping
1	Introduction Overview Purpose Scope Benefits Objectives Structure of this Guide Key Concepts Current Regulatory Situation	Section 1 Introduction Background Purpose Scope Structure of this Guide Key Concepts Regulatory Focus
2	Risk Management Process Overview Process Steps Points to Consider	Section 5 Quality Risk Management Introduction Process Risk Assessment Quality Risk Management Approach Product and Process Context
3	Applying the Risk Management Process Corporate level Activities Applying the process to New/Existing Systems Previously assessed Systems	Section 5 Quality Risk Management Appendix M1: Corporate Data Integrity Program
4	Controls Electronic Record Controls Electronic Signature Controls Hybrid Records User/Supplier Responsibilities Technical and procedural controls and requirements	Section 5 Quality Risk Management Appendix D3: Risk Control Measures for Records, Data, and Electronic Signatures Appendix O2: Paper Records and Hybrid Situations Appendix D1: User Requirements
	Appendix 1 – Validation	Validation of GxP Computerized Systems is covered in GAMP 5. The need for validation of systems for intended use related to Data Integrity is covered in RDI Section 2 Regulatory Focus.
	Appendix 2 – Audit Trail and Data Security	Appendix M4: Data Audit Trail and Audit Trail Review Appendix D1: User Requirements Appendix D3: Risk Control Measures for Records, Data, And Electronic Signatures
	Appendix 3 – Record Retention, Archiving, and Migration	Appendix O1: Retention, Archiving, And Migration
	Appendix 4 – Copies of Records	Section 4 Data Life Cycle Appendix M6: Inspection Readiness
	Appendix 5 – 21 CFR Part 11 Legacy Systems	Appendix M1: Corporate Data Integrity Program
	Appendix 6 – Examples of Records and Signatures Required by GxP Regulations	Excerpts of regulations no longer included in Guidance. Refer to primary regulatory sources
	Appendix 7 – Case Studies	Case study information to be published separately or as input to proposed future Guidance and Practical Approaches to Records and Data Integrity document
	Appendix 8 – Copy of GAMP 4, Appendix M3 Guideline for Risk Assessment	Section 5 Quality Risk Management
	Appendix 9 – Example Template Form for Risk Assessment and Identification of Controls	Appendix D3: Risk Control Measures for Records, Data, And Electronic Signatures [Guide does not include template forms].
	Appendix 10 – Form for Previously Assessed 21 CFR Part 11 Systems	Appendix M1: Corporate Data Integrity Program [Guide does not include template forms].
	Appendix 11 – Current Regulatory Situation	Section 2 Regulatory Focus.
	Appendix 12 – Glossary	Glossary
	Appendix 13 – References	References