Hello Deirdre, Graham and all.
I was looking at Graham’s discussion board (askaboutValidation.com) and noticed Deirdre’s questions about Validation software.
PENSA has a software application called “The Validation Manager (TVM)” that was created about 6 years ago. TVM is used to manage all data related to validation including the Requirements, Design Specifications, Tests, Policies, Procedure and Regulations. TVM acts as a data repository holding all of this information, then it allows the validation consultant (or employee) the opportunity to select the relevant data from the repository to create the complete Validation Document Set. The trace matrix for these documents is automatically generated by TVM and can be view or exported for printing.
TVM manages the complete validation process from document creation through to test execution and review.
TVM uses electronic signatures and e-mail routing and is Part 11 compliant. More information about TVM can be found on our website at
We are currently working on a replacement (upgrade) for TVM called PENSAssure. This enhancement takes TVM beyond validation and into the Regulatory Compliance territory. PENSAssure is currently being tested and should be release to clients in January 2007.
Please feel free to contact me if you have any questions or if you would like a live (web) demo of our software.
Technical Services Manager
PENSA Technology Solutions Inc.