Learnaboutgmp Community

Validation Management Software

Hi

Does any one in the forum have any experience of working with a Validation Management System e.g. Valgenesis.? Do you find these systems useful? What is the cost of such a system (per user licence)? What systems are available? Are there agents for these systems in Ireland/UK?

Thanks for your help

Regards
Deirdre Matthews
Matthews Consulting

www.matthewsconsulting.biz

Hi Deirdre,

I haven’t come across that company before, have you ever used it.

Does it provide a complete electronic validation record for all the

documentation assocaited with a Val Plan. It sounds like a useful tool

but in my experience would this slow down the validation time even

further compared to a paper based system.

Don’t get me wrong I am all for an electronic Validation system, but

getting buy in from the powers that be might be difficult as the whole

validation lifecycle is a slow process anyway.

Just a few thoughts, would like to open a discussion about this topic if anyone else

would like to chip in.

Regards

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
www.GMPs.com
.

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.

David Smith
Technical Services Manager
PENSA Technology Solutions Inc.
1-613-345-7925 x109

www.GMPs.com

Hi Deirdre

Are you looking for Validation Project Management, with tasks, reporting, status, document workflow etc.

OR

Are you looking for managing Engineering Data through to automatically generating C&Q documentation and enabling all disciplines to work on the same dataset?

OR

Pre-defined templates, protocol tests and standard specification data for typical plants?

OR

all of the above

regards
Donagh Kiernan
Campbell Informatics

www.campbellinformatics.com