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Validation

 

Experience to save your time and secure your operations. 

 

You are new to computer systems validation? 

Validation is an additional burden which keeps you from your core tasks?

We are specialized in the validation of computerized systems in regulated environments (GxP, 21 CFR part 11). Our validation services are based on many years of experience with leading industrial customers in Europe and the USA as well as numerous successful audits.

 

 

 

Core areas of our validation services are:

  • Stand-alone systems
  • server, clients, networks
  • Standard software
  • Custom configured software
  • Bespoke software systems
  • Excel forms and worksheets
  • Computer-operated (Lab-)equipment

 

Scope of validation services:

  • Definition and review of
    • User Requirements Specifications
    • Functional Specifications
    • Technical Specifications
  • Validation plans
  • Test specifications
    • We are especially experienced with this critical step in a validation process
  • System tests (IQ, OQ, PQ)
  • Documentation
    • In many cases, use of our templates can simplify this step

 

Download Fact Sheet

Compact facts about our validation services

© BioMedion GmbH • Neuendorfstrasse 20B • 16761 Hennigsdorf • Telefon: 03302 202 3401 • info@biomedion.de • www.biomedion.de