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.
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ISPE Pharma 4.0 Baseline Guide – Enabling Digital Business Transformation
ISPE Pharma 4.0 Baseline Guide – Enabling Digital Business Transformation Complimentary Learning…
Video
Digital Display Labeling in Clinical Trial Supply Chains
Digital Display Labeling in Clinical Trial Supply Chains Complimentary Learning Level: Basic Session…
iSpeak Blog
European Initiatives to Advance Manufacturing Digitalization
One of the keynote sessions of the 2024 ISPE Europe Annual Conference held 16-18 April in Lisbon…
Video
Unlocking the Power of Unified Capital Project Management for Pharma Companies
Unlocking the Power of Unified Capital Project Management for Pharma Companies Complimentary…
PE Articles
Validation & Data Integrity in eClinical Platforms
To address the trial specific setups, eClinical solutions have to be built from various integrated…
PE Articles
Considerations for a Corporate Data Integrity Program
This Concept Paper focuses on electronic records and computerized systems – a key area of emphasis…
PE Articles
Using SaaS in a Regulated Environment – A Life Cycle Approach to Risk Management
In the evolving regulated IT environment there are many things to consider when thinking of turning…
PE Articles
Data Privacy: A Compliance Blind Spot
This Concept Paper aims to highlight where Data Privacy regulations could apply, and the…
PE Articles
Pharma 4.0 – Towards IT/OT Architectures for Prescriptive Maintenance
Faced with global competition and shrinking margins, (bio)pharmaceutical manufacturers worldwide are…
Video
Fireside Chat on Transfers According to Annex 1
Fireside Chat on Transfers According to Annex 1 Complimentary Learning Level: Intermediate Session…
PE Articles
Process Events for the Life Science Industry - Information Model Concept on OPC UA for Alarms and Audit Trails
This Concept Paper proves that a standard model within OPC UA Alarms and Conditions (OPC UA Part 9)…
iSpeak Blog
Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization
The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech…
Guidance Documents
Advanced Manufacturing (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 (11)
- 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 5 Guide 2nd Edition
- 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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Webinars
iSpeak Blog Posts
Pharmaceutical Engineering Magazine Articles
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…
Pharma 4.0™ Is Gaining Momentum and Driving Innovation
The fifth Pharma 4.0™ conference was held December 2022 in Vienna, Austria, in combination with the…
SPuMoNI: Enhancing Pharma Data Quality through Smart Technologies
Funded by the European Commission from 2019, the Smart Pharmaceutical Manufacturing Project (SPuMoNI…
From Data to Knowledge Management: What to Consider
Although data and knowledge are both stand-alone disciplines that need to be systematically managed…
A Beginner’s Guide to IT System Inspection Readiness
This article provides a beginner’s overview of how organizations can achieve a state of preparedness…
ISPE Briefs: New Guidance Document Available on Data Integrity by Design
Data Integrity by Design is the concept that data integrity must be incorporated from the initial…
Videos
White Papers
January / February 2024
Stakeholders across industries are becoming accustomed to using information technology (IT) systems…
Pharmaceutical Job Board
Professional Development Training
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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