Computer System Validation: Pharmaceutical, Biologics, and Medical Device Regulations, Concise Reference

Computer System Validation: Pharmaceutical, Biologics, and Medical Device Regulations, Concise Reference is a unified reference combining the U.S. Food and Drug Administration’s (FDA) and the European Medicines Agency’s (EMA) regulations, guidance, and associated documents pertaining to the validation of computer systems in the regulated life sciences industries.

This reference book compiles the pertinent regulations from of 21CFR (Code of Federal Regulations, Title 21) and Eudralex Volume 4. A selection of related guidance documents is included with a combined glossary of defined terms and a detailed index.

Included Documents and Features:

• -FDA Overview and Orientation
• -Introduction to Computer System Validations
• -Part 11: Electronic Records; Electronic Signatures (21 CFR 11)
• -Part 820: Quality Systems Regulation (21 CFR 820)
• -Annex 11: Computerised Systems
• -Annex 15: Qualification and Validation
• -GMP Medicinal Products for Human and Veterinary Use: Chapter 4
• -Software as a Medical Device: Key Definitions
• -Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations
• -Software as a Medical Device: Application of Quality Management System
• -Software as a Medical Device: Clinical Evaluation
• -Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
• -Computerized Systems Used in Clinical Investigations
• -Computerized Systems Used in Clinical Trials
• -Deciding When to Submit a 510(k) for a Software Change to an Existing Device
• -Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
• -Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software
• -Policy for Device Software Functions and Mobile Medical Applications
• -General Wellness: Policy for Low Risk Devices
• -Blood Establishment Computer System Validation in the User’s Facility
• -Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
• -Off-The-Shelf Software Use in Medical Devices
• -Data Integrity and Compliance with Drug CGMP
• -Qualification and Classification of Stand Alone Software
• -Combined Glossary and Index