The importance of ensuring data integrity is reflected in guidance, citations, and public comments of Regulators and Health Agencies. A number of companies have suffered serious regulatory and financial consequences as a result of unacceptable pharmaceutical data integrity practices. The current global regulatory focus and increased interest on data integrity has resulted in the need to develop industry guidance on this topic. A holistic approach to records and data integrity is required.
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 approach is intended to encourage innovation and technological advancement while avoiding unacceptable risk to product quality, patient safety, and public health.
The ISPE GAMP Guide: Records and Date Integrity 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 the GAMP Community of Practice (CoP) of ISPE; a world-wide community of practitioners and subject matter experts who over twenty-five years have been developing internationally accepted guidance on risk-based approaches to safeguard patient safety, product quality, and data integrity.
This Guide has been produced with significant input and review from regulators worldwide, including key specialists from leading regulatory authorities working (MHRA and WHO) in this area.
The ISPE GAMP® Guide: Records and Data Integrity 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, gaining an in-depth understanding of the key requirements and principles, and gain an awareness of practical approaches and techniques to effectively address data integrity challenges. The ISPE GAMP Guide: Records and Data Integrity will assist 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
– Publicación en inglés –
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Fecha de Publicación: 15/03/2017
# Páginas: 152