Published: March 2017

Pages: 152

• Table of Contents​

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:

1. Data integrity requirements, critical areas of regulatory focus and concern, and key concepts
2. Framework for data governance and the importance of human factors
3. Complete data life cycle approach as part of a Quality Management System (QMS), from creation to destruction
4. Further information on how to apply the Quality Risk Management (QRM) approach from ISPE GAMP® 5 to record and data integrity
5. 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

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