ISPE Guidance Documents and Publications
ISPE GAMP® Guide: Records and Data Integrity
 
The ISPE GAMP® Guide: Records and Data Integrity provides you with 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.
 
 
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ISPE D/A/CH Affiliate: Containment Manual (English Translation)
Member Price: $200/€185
Nonmember Price: $395/€360
Available in book and
PDF format
This guide addresses the integrity of GxP records and data used within the regulated life science industries including pharmaceutical, biological, and medical devices. The guidance is intended for regulated companies and suppliers of systems, products, or services in this area, as well as providing a useful reference for regulators.
 
Key Concepts that you can take away from this guide include:
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Risk Management Approach
grey-roundbullet.jpg Data Governance
grey-roundbullet.jpg Data Life Cycle
grey-roundbullet.jpg Key Concepts Summarized by ALCOA and ALCOA+
grey-roundbullet.jpg GxP Computerized System Life Cycle
 
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