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Qualification / Validation

Computer System Validation in the EU
€ 345.00
€ 410.55
Der MwSt.-Satz richtet sich nach der Produktart, auf Print-Produkte werden 7% und auf digitale Produkte 19% berechnet. Bei Bundle-Produkten werden beide Steuersätze berücksichtigt. Vor dem endgültigen Auslösen der Bestellung wird die MwSt. bestellspezifisch angezeigt.
pdf download
A step-by-step guide to implementing a computer validation program that will satisfy U.S. and EU regulations
Edition: 1st edition 2013
71 Pages
ISBN: 978-3-943267-78-5
Delivery: immediately after receipt of payment
Excerpt from the GMP Compliance Adviser

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.

This ebook is 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 much more
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.

Reading Sample

Computer System Validation in the EU - Reading Sample

Technical Requirements

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Please note the following procedure guidelines:

If you choose payment by bank transfer:

  • You will receive an advance invoice.
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  • The invoice will be sent by postal mail as soon as possible.
Roemer, Markus

Markus Roemer works as an independent consultant at comes compliance in Ravensburg. He is involved in a wide range of areas including the validation of computerised systems, auditing, quality management, project management and compliance management. Since 2008, he has been working as an ISPE ambassador for the DACH affiliate.

Questionnaire for preparing GMP-inspections