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:
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:
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.
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