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The evolution from Validation to Corporate Compliance - PENSAssure: PENSAssure version 5.0 is now available!

PENSAssure is a Windows-based software program that offers an expert knowledgebase of compliance and regulatory information to assist with every kind of validation/compliance project. Using PENSAssure greatly reduces the cost and complexity of managing projects due to unique features such as the Traceability Matrix, electronic approval and signatures and the preparation of validation/compliance documents.

The Traceability Matrix feature allows links to be established between:

  • Requirements and tests
  • Requirements and design statements
  • Requirements and regulations
  • Employees and training records
  • Requlations and audits
  • any item to any other items

PENSAssure maintains the compliance knowledge necessary to create all validation/complaince documents including:

  • Validation plans
  • User requirement specifications
  • Functional requirements specifications
  • Design specifications
  • Test protocols and reports
  • Final validation reports
  • Audit reports
  • Training records
  • Compliance documents

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

The development of PENSAssure was lleveraged off our experience with The Validation Manager (TVM) and was conducted with Part 11 compliance in mind. Audit trails, electronic signatures, signature routing via e-amil, 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.

PENSAssure version 5.0 is now available! 
This version has updates and improvements including:

Email routing for review and 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.
More intuitive use interface.

There's not a validation or compliance tool like it.

Download the version 5.0 PENSAssure brochure in Adobe pdf. Link to Adobe

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

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

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