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PAS-X SERVICES


 Overview


Validation Support
In any regulated environment, validation is absolutely indispensable when implementing a new computerized system. Werum lays the foundation for a fast and successful validation of its PAS-X system.
Advantages through long Experience and well-established Product
As a mature product, PAS-X offers advanced features and high-quality functionality and its business processes already reflect and represent all the specifications and requirements laid out for regulatory compliance in the pharmaceutical industry. PAS-X, a pretested product software, closely follows the interpretation of a risk-based approach as specified in GAMP 5 and thereby minimizes the validating efforts involved in a project.

Looking back on many years of experience managing and executing projects in the highly regulated pharmaceutical industry, Werum built up a most comprehensive knowledge and expertise and came up with project-supporting tools for validating computerized systems. This is a strong foundation you can trust. Since we are involved in many important committees, we have our finger on the pulse of the latest developments in the pharmaceutical world and play an active role in these committees, drawing on our practical experience and expertise.

The most important regulatory laws and regulations in Europe and the United States are listed below:
  • FDA 21 CFR Part 11
  • FDA 21 CFR Part 210
  • FDA 21 CFR Part 211
  • EU-GMP Guidelines
  • EU-GMP Annex 11
  • EU-GMP Annex 15
  • AMWHV (Arzneimittel- und Wirkstoffherstellungsverordnung - German Regulation for Manufacturing Pharmaceutical Drugs and Active Ingredients)
and related guidelines
  • PIC/S PI 011
  • GAMP 5 and corresponding Good Practice Guides (GPG)
Our Validation Services
We offer support for the following tasks:
  • We review the customer's QM system with respect to the validation needs for computerized systems
  • We identify the documents needed and define the procedures to be used for creating these documents
  • We prepare a validation plan
  • We create an IT-related risk analysis and describe the computerized business processes
  • We write test specifications and run tests:
    • Using specific tools to accomplish complete transparency and traceability
    • IQ based on an installation plan and system manual
    • OQ based on business process description and risk analysis
    • PQ based on user requirements specification
SDLC Approach based on GAMP5

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