Published: March 2017
Pages: 152
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:
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:
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 |
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1 |
Introduction
|
Section 1 Introduction
|
2 |
Risk Management Process
|
Section 5 Quality Risk Management
|
3 |
Applying the Risk Management Process
|
Section 5 Quality Risk Management Appendix M1: Corporate Data Integrity Program |
4 |
Controls
|
|
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Appendix 1 – Validation |
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Appendix 2 – Audit Trail and Data Security |
|
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Appendix 3 – Record Retention, Archiving, and Migration |
Appendix O1: Retention, Archiving, And Migration |
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Appendix 4 – Copies of Records |
|
|
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Appendix 5 – 21 CFR Part 11 Legacy Systems |
Appendix M1: Corporate Data Integrity Program |
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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 |
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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]. |
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Appendix 10 – Form for Previously Assessed 21 CFR Part 11 Systems |
Appendix M1: Corporate Data Integrity Program [Guide does not include template forms]. |
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Appendix 11 – Current Regulatory Situation |
Section 2 Regulatory Focus. |
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Appendix 12 – Glossary |
Glossary |
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Appendix 13 – References |
References |
Available in German |
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ISPE GAMP Leitfaden zur Aufzeichnungs- und Datenintegrität | |
Individual Download Member Price Non-member Price |
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