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.
iSpeak Blog
Limitations of Current Digital Validation Tools
The pharmaceutical industry is undergoing a significant transformation, moving away from traditional…
iSpeak Blog
Data Management Requirements for Sterile Manufacturing
Ronald Bauer, PhD and Christina Meissner, PhD from the Austrian Agency for Health and Food Safety…
Video
Secrets in the Digital Transformation Vibe
Secrets in the Digital Transformation Vibe Powered and Led by Women in Pharma ® This session…
Video
Improved Data Integrity via Digitization of Environmental Monitoring
Improved Data Integrity via Digitization of Environmental Monitoring Complimentary Learning Level…
PE Articles
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…
PE Articles
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…
PE Articles
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…
PE Articles
Pharma 4.0 – Plug & Produce Architectural Principles
A set of principles to be considered in the journey to adopting and deploying an architecture…
PE Articles
ISPE Releases New GAMP® Good Practice Guide
This summer ISPE released the ISPE GAMP® Good Practice Guide: Validation and Compliance of…
Video
Bridging the Gap: Leveraging Capital Project Data to Enhance the Pharma Manufacturing Operations Lifecycle
Bridging the Gap: Leveraging Capital Project Data to Enhance the Pharma Manufacturing Operations…
Video
ALCOA++: Leveling Up Data Integrity
ALCOA++: Leveling Up Data Integrity Complimentary Session Length: 1 hour ALCOA has been the hallmark…
iSpeak Blog
Data Integrity and Large-Scale Systems
This blog post will discuss the relationship between large systems that manage records at the multi…
Guidance Documents
Advanced Manufacturing (1)
Artificial Intelligence (1)
Commissioning & Qualification (1)
Data Integrity (16)
- Baseline Guide Vol 8: Pharma 4.0 1st Edition
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition
- GAMP Good Practice Guide: Manufacturing Execution Systems
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- GAMP RDI Good Practice Guide: Data Integrity by Design
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP 5 Guide 2nd Edition
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Testing GxP Systems 2nd Edition
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
GAMP® (15)
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition
- GAMP Good Practice Guide: Manufacturing Execution Systems
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- GAMP RDI Good Practice Guide: Data Integrity by Design
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP 5 Guide 2nd Edition
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Testing GxP Systems 2nd Edition
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
Knowledge Management (1)
Manufacturing Operations (1)
Pharma 4.0™ (1)
Validation (10)
- GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
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iSpeak Blog Posts
Pharmaceutical Engineering Magazine Articles
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…
In-Silico Data-Driven Mechanistic Model–Assisted Process Validation
The US Food and Drug Administration (FDA) advocates for the integration of quality by design (QbD)…
Digital Display Labeling in Clinical Supplies for Clinical Trials
Digital display labels (DDLs) offer an alternative solution to eliminate manual relabeling in the…
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…
Videos
White Papers
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…
Pharmaceutical Job Board
Professional Development Training
A GAMP® Guide to Computerized Systems Compliance
Fundamental Principles of Compliance for Computerized Systems: Implementing the GAMP® 5 Guide This fundamental online course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP ® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner. Course Modules…
GAMP® Data Integrity 21 CFR Part 11, 2-Day Training Course
The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical, biotech, and medical device business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This…
GAMP® Data Integrity 21 CFR Part 11, 3-Day Training Course
This GAMP Data Integrity 21 CFR Part 11 Training Course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data.
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