Content focuses on the financial impact of data management systems on drug development, manufacturing, and distribution; the basic computer system life cycle model and the activities and software quality assurance practices in each phase; and the controls and methods necessary to maintain data integrity and security.
iSpeak Blog
Innovation Meets Talent: 2024 ISPE Annual Meeting & Expo Tackles the Future of Pharmaceutical Workforce
The unstoppable progress in technology and scientific knowledge is reshaping our industry. It is…
iSpeak Blog
Navigating the Latest US FDA Draft Guidelines on Use of Decentralized Clinical Trial Designs
The landscape of clinical trials has evolved significantly with the pandemic and interest in…
iSpeak Blog
The Pharmaceutical Industry’s Mission to Advance the Next Generation of Medicines in Collaboration with Regulators
The ongoing evolution of the pharmaceutical industry, aimed at propelling the next generation of…
Video
AI/ML in Regulated (GxP) Life Sciences Sectors - Project Phase: Iterative training and fine-tuning
AI/ML in Regulated (GxP) Life Sciences Sectors - Project Phase: Iterative training and fine-tuning…
Video
Attend the 2024 ISPE Annual Meeting & Expo
Attend the 2024 ISPE Annual Meeting & Expo Our comprehensive education program offers cutting-edge…
Video
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma…
iSpeak Blog
Unlock New Insights and Innovations: Explore the 2024 ISPE Annual Meeting & Expo Education Tracks
The 2024 ISPE Annual Meeting & Expo is the pharmaceutical industry’s gateway to discovering the…
PE Articles
Finding the Assurance in Computer Software Assurance
Computer software assurance (CSA) has been discussed widely in industry over the past five years…
iSpeak Blog
Pharma 4.0™ and Annex 1 – The Perfect Fit
What do the EU GMP Annex 1 and the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition) have to…
iSpeak Blog
Unleash Your Potential at the 2024 ISPE Annual Meeting & Expo: Dive into Cutting-Edge Expertise and Unrivaled Networking Opportunities
As the global pharmaceutical industry continues to evolve, staying ahead of the curve is more…
iSpeak Blog
Elevate Your Career and Stay Ahead: Join Industry Leaders at the 2024 ISPE Annual Meeting & Expo
As the pharmaceutical landscape rapidly evolves, staying informed and connected with industry…
iSpeak Blog
Message From the Chair: Why Attend the 2025 ISPE Facilities of the Future Conference
The 2025 Facilities of the Future Conference will explore innovations in facility design and…
iSpeak Blog
Innovation Meets Talent: 2024 ISPE Annual Meeting & Expo Tackles the Future of Pharmaceutical Workforce
The unstoppable progress in technology and scientific knowledge is reshaping our industry. It is…
iSpeak Blog
Navigating the Latest US FDA Draft Guidelines on Use of Decentralized Clinical Trial Designs
The landscape of clinical trials has evolved significantly with the pandemic and interest in…
iSpeak Blog
The Pharmaceutical Industry’s Mission to Advance the Next Generation of Medicines in Collaboration with Regulators
The ongoing evolution of the pharmaceutical industry, aimed at propelling the next generation of…
Video
AI/ML in Regulated (GxP) Life Sciences Sectors - Project Phase: Iterative training and fine-tuning
AI/ML in Regulated (GxP) Life Sciences Sectors - Project Phase: Iterative training and fine-tuning…
Video
Attend the 2024 ISPE Annual Meeting & Expo
Attend the 2024 ISPE Annual Meeting & Expo Our comprehensive education program offers cutting-edge…
Video
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma…
iSpeak Blog
Unlock New Insights and Innovations: Explore the 2024 ISPE Annual Meeting & Expo Education Tracks
The 2024 ISPE Annual Meeting & Expo is the pharmaceutical industry’s gateway to discovering the…
PE Articles
Finding the Assurance in Computer Software Assurance
Computer software assurance (CSA) has been discussed widely in industry over the past five years…
iSpeak Blog
Pharma 4.0™ and Annex 1 – The Perfect Fit
What do the EU GMP Annex 1 and the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition) have to…
iSpeak Blog
Unleash Your Potential at the 2024 ISPE Annual Meeting & Expo: Dive into Cutting-Edge Expertise and Unrivaled Networking Opportunities
As the global pharmaceutical industry continues to evolve, staying ahead of the curve is more…
Guidance Documents
Advanced Manufacturing (1)
+Commissioning & Qualification (1)
+Data Integrity (15)
+GAMP® (14)
+Knowledge Management (1)
+Pharma 4.0™ (1)
+Regulatory (1)
+Validation (11)
+Community Discussions
Community Discussions
Apr 02, 2025
Data Integrity
Mar 28, 2025
Information Systems
Regulatory
Advanced Manufacturing
Active Pharmaceutical Ingredients
Mar 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Mar 20, 2025
Mar 20, 2025
Mar 20, 2025
Data Integrity
Pharmaceutical Engineering Magazine Articles
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…
Hands-on Innovation Management with the ISPE Hackathon
Innovation is an integral part of corporate strategy. Initiatives to facilitate innovation are…
Finding the Assurance in Computer Software Assurance
Computer software assurance (CSA) has been discussed widely in industry over the past five years…
Artificial Intelligence Governance in GxP Environments
Artificial intelligence (AI) is used by pharmaceutical and biotech companies, providing support from…
Pharma Facilities, Composable Tools, and Validation 4.0
The pharmaceutical industry stands at the precipice of a revolution as emerging digital technologies…
2024 ISPE Facilities of the Future Conference: Keynote Presentations
The 2024 ISPE Facilities of the Future Conference opened on 29 January in San Francisco, California…
2024 ISPE Biotechnology Conference Q&A
The 2024 ISPE Biotechnology Conference will be held 17–18 June in Boston, Massachusetts, and…
Pharma 4.0™ Plug and Produce Working Group Publishes Concept Papers
One of the primary technical objectives of the ISPE Pharma 4.0™ Plug and Produce Working Group is to…
ISPE Briefs: Introducing New ISPE Baseline® Guides
The newly released third edition of the ISPE Baseline® Guide: Volume 6 – Biopharmaceutical…
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…
Hands-on Innovation Management with the ISPE Hackathon
Innovation is an integral part of corporate strategy. Initiatives to facilitate innovation are…
Finding the Assurance in Computer Software Assurance
Computer software assurance (CSA) has been discussed widely in industry over the past five years…
Artificial Intelligence Governance in GxP Environments
Artificial intelligence (AI) is used by pharmaceutical and biotech companies, providing support from…
Pharma Facilities, Composable Tools, and Validation 4.0
The pharmaceutical industry stands at the precipice of a revolution as emerging digital technologies…
2024 ISPE Facilities of the Future Conference: Keynote Presentations
The 2024 ISPE Facilities of the Future Conference opened on 29 January in San Francisco, California…
2024 ISPE Biotechnology Conference Q&A
The 2024 ISPE Biotechnology Conference will be held 17–18 June in Boston, Massachusetts, and…
White Papers
January / February 2024
Stakeholders across industries are becoming accustomed to using information technology (IT) systems…
March / April 2022
This article aims to refresh information on open-source software (OSS) within regulated computerized…
Webinars
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ISPE in the News
Latest
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ISPE Training: Process Validation Training Course, 8 - 10 April
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Discover Exciting Career Opportunities on ISPE's Job Board
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Steele Appointed Acting Director of US FDA's CBER
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US FDA to Cut Back on Routine Inspections
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Tariff Threats Create Uncertainty in Pharma Market
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Expecting the Unexpected Ensures Continuity in Biopharma Manufacturing
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Digital Twin may Streamline Gene Therapy Production
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AMT Designation Granted to Cellares' Cell Shuttle
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Innovative Culture Media Support Intensified Processes
- Navigating Category 3 Compounding Challenges
Pharmaceutical Job Board
iSpeak Blog Posts
Special Initiatives
Videos
Video
Agile Pharma Manufacturing With Real-Time Scheduling & MES Integration
Agile Pharma Manufacturing With Real-Time Scheduling & MES Integration Complimentary Learning Level…
Video
AI/ML in Regulated (GxP) Life Sciences Sectors - Concept/Project Phase: Representative Data Sets
AI/ML in Regulated (GxP) Life Sciences Sectors - Concept/Project Phase: Representative Data Sets…
Video
Demystifying Machine Learning: Regression Models, Classification Models, and the AI Landscape
Demystifying Machine Learning: Regression Models, Classification Models, and the AI Landscape…
Video
AI/ML in Regulated (GxP) Life Sciences Sectors - Concept Phase: Business Need & Risk Assessment
AI/ML in Regulated (GxP) Life Sciences Sectors - Concept Phase: Business Need & Risk Assessment…
Video
ISPE Expert Xchange GAMP®: Implementing Data Integrity by Design
ISPE Expert Xchange GAMP®: Implementing Data Integrity by Design Next-Generation Virtual…
Video
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma…
Video
AI/ML in Regulated (GxP) Life Sciences Sectors - Project Phase: Iterative training and fine-tuning
AI/ML in Regulated (GxP) Life Sciences Sectors - Project Phase: Iterative training and fine-tuning…
Video
Attend the 2024 ISPE Annual Meeting & Expo
Attend the 2024 ISPE Annual Meeting & Expo Our comprehensive education program offers cutting-edge…
Video
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…
Video
Unlocking the Power of Unified Capital Project Management for Pharma Companies
Unlocking the Power of Unified Capital Project Management for Pharma Companies Complimentary…
Video
Register Now for the 2024 ISPE Annual Meeting & Expo
This signature gathering is not just an opportunity to learn but also to connect. From emerging…
Video
Agile Pharma Manufacturing With Real-Time Scheduling & MES Integration
Agile Pharma Manufacturing With Real-Time Scheduling & MES Integration Complimentary Learning Level…
Video
AI/ML in Regulated (GxP) Life Sciences Sectors - Concept/Project Phase: Representative Data Sets
AI/ML in Regulated (GxP) Life Sciences Sectors - Concept/Project Phase: Representative Data Sets…
Video
Demystifying Machine Learning: Regression Models, Classification Models, and the AI Landscape
Demystifying Machine Learning: Regression Models, Classification Models, and the AI Landscape…
Video
AI/ML in Regulated (GxP) Life Sciences Sectors - Concept Phase: Business Need & Risk Assessment
AI/ML in Regulated (GxP) Life Sciences Sectors - Concept Phase: Business Need & Risk Assessment…
Video
ISPE Expert Xchange GAMP®: Implementing Data Integrity by Design
ISPE Expert Xchange GAMP®: Implementing Data Integrity by Design Next-Generation Virtual…
Video
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma…
Video
AI/ML in Regulated (GxP) Life Sciences Sectors - Project Phase: Iterative training and fine-tuning
AI/ML in Regulated (GxP) Life Sciences Sectors - Project Phase: Iterative training and fine-tuning…
Video
Attend the 2024 ISPE Annual Meeting & Expo
Attend the 2024 ISPE Annual Meeting & Expo Our comprehensive education program offers cutting-edge…
Video
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…