£47.57

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

Software Testing

Price data last checked 67 day(s) ago - refreshing...

View at Amazon

Price History & Forecast

Last 24 days • 24 data points (No recent data available)

Historical

Generating forecast...

Price Distribution

Price distribution over 24 days • 1 price levels

Days at Price

Price Analysis

Most common price: £48 (24 days, 100.0%)

Price range: £48 - £48

Price levels: 1 different prices over 24 days

Description

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

Product Specifications

Format: paperback
ASIN: 1937258254
Category: Books > Subjects > Computing & Internet > Programming > Software Design, Testing & Engineering > Software Testing
Domain: Amazon UK
Release Date: 31 March 2021
Listed Since: 01 October 2021

Barcode

No barcode data available

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

Price History & Forecast

Price Distribution

Price Analysis

Description

Product Specifications

Barcode

Similar Products You Might Like

Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance

Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance

Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies

Practical Guide to 21 CFR Part 11: Your Essential Handbook for Navigating 21 CFR Part 11

Practical Guide to 21 CFR Part 11: Your Essential Handbook for Navigating 21 CFR Part 11

Design Controls, Risk Management & Process Validation for Medical Device Professionals: A Comprehensive Handbook for Interpreting and Implementing Design Control Regulation

21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

FDA Bioequivalence Standards: 13 (AAPS Advances in the Pharmaceutical Sciences Series, 13)

Laboratory Control System Operations in a GMP Environment

Contract Research and Development Organizations-Their History, Selection, and Utilization

Integrated Safety and Risk Assessment for Medical Devices and Combination Products

Integrated Safety and Risk Assessment for Medical Devices and Combination Products

Pharmaceutical Dosage Forms - Parenteral Medications: Volume 3: Regulations, Validation and the Future

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook

FDA Regulatory Affairs: Third Edition

Nonclinical Drug Administration: Formulations, Routes and Regimens for Solving Drug Delivery Problems in Animal Model Systems

CRC Press Planning Quality Project Management of EMR/EHR Software

FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics

Development of Biopharmaceutical Drug-Device Products: 35 (AAPS Advances in the Pharmaceutical Sciences Series, 35)

Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry (Advances in Medical Technologies and Clinical Practice)