Solution Benefits

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If It's Not Documented...It Didn't Happen

ValidationMaster™ has created a validation documentation package comprised of a series of documents and test scripts that allow you to quickly and cost effectively qualify the baseline ValidationMaster™ environment.

 

QualificationMaster™ is the documentation pack for ValidationMaster™. QualificationMaster™ focuses on the technical controls and functions within ValidationMaster™ as well as the quality procedural controls that need to be in place. The QualificationMaster™ Documentation Pack enables you to clearly document the system and test it to ensure that it has been configured correctly.

The QualificationMaster™ Documentation Pack is a Full Set of Validation Deliverables for ValidationMaster™

 

The QualificationMaster™ Documentation Pack is based on ISPE GAMP®5 standards.

  • Validation Master Plan
  • Validation Test Plan
  • User Requirements Specification
  • 21 CFR Part 11 Assessment
  • Risk Assessment
  • Hardware Specification Document
  • Installation Qualification Test Scripts
  • Operational Qualification Test Scripts
  • Specification Traceability Matrix
  • Validation Summary Report
  • Document Master List
           
GAMP® 5 is owned by ISPE, the International Society for Pharmaceutical Engineering - See more at: http://www.ispe.org/gamp5