I am doing Market Research into the use of Validation Management Software for managing all types of Validation in the Life Science industries. Such a software solution would be used to schedule and track validation projects and manage the validation records. Can you see the Life Science industries using such a solution?
Absolutely I would. If a software house could provide a solution that helps with decreasing the time spend undergoing a validation lifecycle then I imagine alot of life science companies being interested.
For such a solution to be successful it would have to highly configuarable and also user friendly.
The last thing people want is yet another software solution that adds complexity to the task of validation.
I would love to see how such a solution would handle the traceability matrix issue.
Another great feature would be providing the capability to link all of these docs through the MVP thus providing maximum visibility.
Just a few thoughts will be interested to hear more views.
I’ll put this thread on the homepage, seems like a good one for debate
We have a software solution that does the following:
- It manages all compliance content for a compliance project such as validation, by treating things like requirements and tests as data objects.
- Links can be created between any data object to create relationships and generate traceability matrices (reqs to design, reqs to tests, regs to reqs etc)
- Any type of document can be assembled from the data objects such as a validation plan, risk management document, protocol, report, list of regulations, requirements etc.
- Documents can be managed and tracked in a project for version control, electronic approval, routing.
- Any change to any data object forces the creation of another revision in any linked object and its parent document.
- Full electronic signatures and electronic records compliance with Part 11 (complex passwords, active directory, audit trails, forced sign off, role based security etc.)
- Automated testing including attachment of any supporting evidence (video, graphics, documents, other objects etc).
The software is currently in use at the largest medical device manufacutrer in the world and is also installed at other companies within the Life Sciences sector.
From analysis of this software application used on many validation projects over the last few years, it offers significant savings during a regular validation project for traceability matrix generation and document management and also during test execeution. Its benefits increase exponentially though with managing the ongoing maintenance of a validated system as it is able to generate very specific protocols for change control basically at the click of a mouse.
I would rather get permission from Graham before revealing any contact information, however I would be delighted to discuss the software, its capabilities and its benefits generically if that is preferred by forummers.
Thats not a problem, perhaps you could send me information in the form of a case study or more details on it’s capability along with screen shots, white papers, etc and I will generate a case study and highlight it on our homepage.
I could also send it out as part of our May eletter aswell.
This forum is all about information sharing so if you want to put your contact details in this thread aswell thats fine.
I’ve recently been looking at a couple of options for just such a system. What I have found is that for the most part they were developed for computerized systems/software validation projects at larger companys that may have many of these projects going on at a given time.
I am currently at a site where our validation group is small and I don’t have the luxury of being a full time project administrator. In addition, CSV is a very small part of our work load. The bulk of our work is with equipment and processes.
I would definitely be interested in a validation management system IF it were geared toward a more flexible use of both in-house and vendor generated documents, and was really designed to handle equipment, cleaning and process vaildation.
Yes, I believe the company I work for might consider using an electronic validation system. However, I believe the company I work for might consider a lot of things (and reject them for whatever reason).
I think a better question to ask is; why doesn’t your company use an electronic validation system?
They don’t exist… (From what I have read, it seems like they do.)
They are not proven in the marketplace…
They cost too much…
Validation is too low a priority…
They don’t save any time or money…
It is easier to hire a consultant…
I think a lightweight and low-cost solution might be manageable, but the problem, as I see it, is that every company has their own philosophy and solution to the question of compliance. Can an electronic solution be flexible enough to adapt to every possible method of validation, and remain stable and reliable?