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Training


Computer System Validation


Validating computers and software systems used by Medical Device Manufacturers can be a daunting and time consuming task. This workshop can help your organization perform cost-effective Computer System Validation based on the FDA QSR and the General Principles of Software Validation guidance document. In this workshop, you will learn cost-effective techniques that can provide your organization with the skills needed to not only be compliant, but be more efficient.

This workshop can be tailored to the specifics of your current Quality System. As a result, you can immediately identify areas of potential regulatory exposure. By applying the techniques presented in this workshop, you can minimize or eliminate any potential exposure and improve the effectiveness of your process validation activities.

Topics covered in this workshop include:

  • Computer System Validation Overview

    • Regulations and Guidance Documents
    • Terms and Concepts

  • Requirements Overview

    • Third Party Software
    • OTS Software
    • Home-grown Software

  • Validation Overview

    • Test Planning
    • Test Development
    • Test Execution and Regression Testing
    • Test Reporting

  • Summary and Action Plan






Tailoring

tailor This workshop can be tailored to meet your specific needs.

Call for details...




For further information,

call Steve Rakitin at 508.529.4282

or e-mail him at steve@swqual.com


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Copyright ©2008 Software Quality Consulting, Inc. All rights reserved.

Updated January 2008