Graphic: PENSA Technology Solutions Inc.

Graphic: PENSA Technology Solutions Inc.
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The Validation Manager (TVM): TVM version 4.6 is now available!

The Validation Manager (TVM) is a Windows-based software program that offers an expert knowledgebase of compliance and regulatory information to assist with every kind of validation project. Using TVM greatly reduces the cost and complexity of managing validation projects due to unique features such as the Traceability Matrix and the preparation of validation documents.

The Traceability Matrix feature allows links to be established between:

  • Requirements and tests
  • Requirements and design statements
  • Requirements and regulations

TVM maintains the compliance knowledge necessary to create all validation documents including:

  • Validation plans
  • User requirement specifications
  • Functional requirements specifications
  • Design specifications
  • Test protocols and reports
  • Final validation reports

TVM is also adaptable.
It can be configured by the user to create the validation deliverables needed for any methodology.

The development of TVM was conducted with Part 11 compliance in mind. Audit trails, electronic signatures, digital signatures and other features are designed and built in as part of the application. This forethought of compliance will simplify the validation of the tool.

TVM version 4.6 is now available! 
This version has updates and improvements including:

Email routing for approval.
Embedded object capability; i.e. corporate policies and procedures, image files, web links.
Reporting capability: select a date range and report on a number of query options.
Object variables: populate all objects with the same variable at once, for example site location.

There's not a validation tool like it.

Download the version 4.6 TVM brochure in Adobe pdf. Link to Adobe

Would you like more details about the TVM product? E-mail

Artificial knee joint image Zimmer Inc. Used by permission only.

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