Computer System Validation in the EU
If you manufacture drugs for sale in the EU, beware. Your own computers may be setting a trap for you.
Computer validation is the issue. Just when you think you’ve got the FDA’s requirements figured out, the EU issues its own. Do you know how they differ? Will you be able to satisfy tough audit trail and personnel requirements? And what about your suppliers’ systems, procedures and networks: are they all compliant
To comply in the EU:
- IT infrastructure must be qualified and verified;
- Supplier and service provider IT systems must be audited and validated; and
- Integrity of system operations and information stored in the system must be validated.
Make no mistake: EU inspectors are watching you. Best to learn the rules before making a false step.
It’s a step-by-step guide to implementing a computer validation program that will satisfy U.S. and EU regulations.
In its pages you’ll discover:
- The tools you need to develop your trans-national validation program
- Step-by-step directions for conducting a computer validation risk assessment
- Practical advice for upgrading legacy computer systems to comply with modern validation requirements
- How to meet requirements for electronic signatures, audit trails, document creation, copying and retention
- And muchmore
Author Markus Roemer, managing director of Comes Compliance Services, is the ideal guide for this task. He specializes in compliance management (GxP), audit service management, computer system validation and quality management systems for a variety of international clients. Mr. Roemer has served as director of compliance management at Systec and Services; senior validation consultant at Invensys Validation Technologies; quality and validation manager at Rockwell Automation Propack Data; and validation coordinator at Vetter Pharma.
The old days of validation simply involved a few key programs. Those days are long over. Computer validation today requires a range of skills, abilities and specialized knowledge – knowledge you must gain if you plan to tap Europe’s rich pharmaceuticals market. Discover what you need to know, and make the profits you deserve to earn. Purchase your copies of Computer System Validation in the EU now.