Data Integrity (DI) is part of the mission to ensure the safety, efficacy, and quality of products produced by the pharmaceutical industry, the global regulators (e.g., the US FDA, EMA, etc.) expect that all data submitted by manufacturers to obtain market approval is both reliable and accurate. Regulators consider the integrity of data, from the moment it is generated to the end of its life cycle, to be a critical component of ensuring that only high-quality and safe drugs are manufactured. Data integrity requires that all data be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
PE Articles
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Video
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iSpeak Blog
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iSpeak Blog
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iSpeak Blog
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Product
GAMP Guide: Artificial Intelligence
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Video
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Video
Introduction to the 2nd Edition of the GAMP GPG on GCP Systems
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iSpeak Blog
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PE Articles
Integrating Environmental Monitoring System Data Into Your Quality Management System
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Video
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Automation Isn’t Automatic: Strategy for Designing and Building a Fully Autonomous Laboratory…
iSpeak Blog
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iSpeak Blog
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iSpeak Blog
Data Management Requirements for Sterile Manufacturing
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Product
GAMP Guide: Artificial Intelligence
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Video
Real Life Case Studies featuring ML/AI including Predictive Maintenance, Defect Detection, Environment
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Video
Introduction to the 2nd Edition of the GAMP GPG on GCP Systems
Introduction to the 2nd Edition of the GAMP GPG on GCP Systems Complimentary Learning Level…
Video
Audit and Oversight Challenges in GCP Systems, with a Focus on Clinical Site Systems
Audit and Oversight Challenges in GCP Systems, with a Focus on Clinical Site Systems Complimentary…
iSpeak Blog
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iSpeak Blog Posts
Pharmaceutical Engineering Magazine Articles
Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact
The Asia Pacific region (APAC), like any large territory, encompasses a blend of well-established…
Leveraging GAMP® 5 Second Edition for Medical Devices
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The Use of Infrastructure as Code in Regulated Companies
IT infrastructure has traditionally been provisioned using a combination of scripts and manual…
Quality Considerations in Disaster Recovery: A Case Study
Due to the growing digitalization of the industry, we are highly dependent on information technology…
Machine Learning Risk and Control Framework
Stakeholders across industries are becoming accustomed to using information technology (IT) systems…
AI/ML Technology: Harnessing AI/ML Technology for the CQV Life Cycle
Technology is advancing at an extraordinary rate. Industries are benefiting from automation and AI…
A GAMP® Approach to Computerized System Life Cycle and IT Process Records
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Digital Display Labeling in Clinical Supplies for Clinical Trials
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Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact
The Asia Pacific region (APAC), like any large territory, encompasses a blend of well-established…
Leveraging GAMP® 5 Second Edition for Medical Devices
This article provides a brief introduction into the standards and regulations for medical devices…
The Use of Infrastructure as Code in Regulated Companies
IT infrastructure has traditionally been provisioned using a combination of scripts and manual…
Quality Considerations in Disaster Recovery: A Case Study
Due to the growing digitalization of the industry, we are highly dependent on information technology…
Machine Learning Risk and Control Framework
Stakeholders across industries are becoming accustomed to using information technology (IT) systems…
AI/ML Technology: Harnessing AI/ML Technology for the CQV Life Cycle
Technology is advancing at an extraordinary rate. Industries are benefiting from automation and AI…
A GAMP® Approach to Computerized System Life Cycle and IT Process Records
This article describes a practical and pragmatic approach to the management of computerized system…
Updated GAMP® GPG Incorporates AI and Open-Source Software
The landscape of clinical trials has been transformed in a post-pandemic world. In July, ISPE…
ISPE Releases New GAMP® Good Practice Guide
This summer ISPE released the ISPE GAMP® Good Practice Guide: Validation and Compliance of…
Global Convergence Opportunities
The regulation of drug shortage prevention has rapidly changed over the past several years due to…
Videos
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January / February 2025
GAMP® is indispensable for safeguarding the safety, quality, and compliance of pharmaceutical…
January / February 2024
Stakeholders across industries are becoming accustomed to using information technology (IT) systems…
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A GAMP® Guide to Computerized Systems Compliance
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