GMP Spezial

Keeping computer infrastructure in a compliant state is becoming more of a key issue for both companies and regulatory authorities.

Using a life cycle approach during Infrastructure Qualification Master Planning is vital to success.
By bringing together risk analysis techniques, project management, infrastructure life cycle approaches, and resources management processes, companies can be assured of both a robust and compliant set-up.

This book provides practical information to enable compliance with computer infrastructure requirements including the verification activities related with the design and deployment.
A practical approach is presented to increase efficiency and to ensure that infrastructure development, verification, and maintenance is correctly achieved.

This must-read book, designed for readers on all levels of information management, explains all the factors necessary for success in a clear and concise approach.

Table of Contents:
Click here to download the Table of contents

- Introduction (Click here to download the Introduction)
- Infrastructure Lifecycle Approach
- Infrastructure Qualification Overview
- FDA Enforcement
- Regulatory Requirements
- 21 CFR Part 11
- Procedural Controls
- Computer Infrastructure Security
- Infrastructure Qualification Planning
- Qualification Testing
- Qualification Testing System-level Software
- Qualification Testing Application Servers and Service Components
- Qualification Testing LAN Devices
- Qualification Testing WAN Devices
- Qualification Testing WAN/LAN System
- Qualification Testing the Storage Area Networks
- Qualification Wireless Services
- Qualification Testing Network Centers
- Qualification Testing Database Manager
- Change Management
- Training
- Remediation Project
- Maintaining the State of Qualification

Companies performing regulated operations

Orlando Lopez is now Director of Information Management at Cordis, a Johnson & Johnson Company in Miami Lakes, Florida. He is a member of the PDA Part 11 Core team, ISPE’s Computer System Validation Sub-Committee (Delaware Valley Chapter) and Pharmaceutical Engineering Editorial Review Board. He is the author of seven books including such best-sellers as Qualification of Computer Networks, Retrospective Validation, and Computer Technologies Security Part 1 all published by SHPL Ltd, UK.

PDA/DHI Publication