Validation Management System - Good or Bad idea?

We are considering developing a Validation Management System.

This system will allow anyone working on a validation project to track every stage of the validation process from URS sign off, to Summary Report approval.

We have three questions:

  1. Do you think this is a good idea?

  2. Would you use an application like this, in your company?

  3. What features would you like to see?

All feedback is most welcome.



I guess the immediate questions that jump to mind are:

  1. How is this different from the other document management systems? The 2 features you mention really only address document management. If that’s the driver, then you’d only be addressing a part of the clients’ needs (likely they would want to do electronic document management for ALL their systems).

  2. I presume the controls would be in place to support Part 11?

  3. Would this be able to be integrated with other electronic document management systems? I don’t recall hearing of any ‘standards’ for such systems so integration seems unlikely.

I would need to see a more detailed feature list to determine if we could use it. As a company that provides validation services, I can see potential utility. For companies that do ‘cradle to grave’ development, it might be too niche-oriented.

Good discussion, I would like to hear more.

Hi Yodon.

To answer your questions, first of all it wouldn’t be a document management system as such, it would function more as a tracking system that would be used to track each document involved in the validation process.

For example, you log into your project and see what status your OQ is at, if you see its being approved then a big green light will appear which means that your allowed to go into PQ.

I don’t envisage too much integration into a document management system, its more a space where you can drill down into each validation project to figure out what the bottle necks are etc and what stage each projects is at.

My vision is to replace Excel sheets and white boards with this application so you have one location for everything.

Absolutely Part 11 controls would be in place with this, this would be a cloud based web application hosted on fully qualified servers with the validation documentation in place. We would manage all changes to the software and use change control for everything so are customers know we are always in compliance.

Document Management Systems’s are fine for housing each document, but as far as I can see I have not come across a good way to track each stage of the validation process, i.e a Validation Management System.

We realize that there would be a huge amount of work involved in developing such an application, and a high degree of cost so we would like to be pretty sure that people would use it on their projects.

Any more questions are most welcome.


I have seen some companies start to use Microsoft Sharepoint 2010 with some addons from Qumas or other companies for this. Sort of a doc mngt on steroids. So will another third party software get used? I do not know as the companies are trying to use what is already on the corporate network.

Yeah all valid points, need to do more research before I decide how to move forward with a software application for the validation world.