Veeva : Prevalidation Helps Companies Speed Time to Market

Veeva Vault RIM Essentials is a great way for small companies to get up and running on a full-featured RIM solution in a matter of weeks, as we detailed in an earlier blog post. For those who qualify, Vault RIM Essentials gives companies the ability to leverage the best industry practices and processes learned from our broad base of customers of all sizes, without having to learn it themselves through trial and error. Giving our Essentials customers these best practice configurations allows us to shorten the implementation timeline significantly, and is key to the success of RIM Essentials.

Additionally, there is another component of Essentials that plays a significant role in keeping our implementation timelines short. That is Veeva's prevalidation of the applications, which removes the need for small companies to develop, run, verify, and rerun validation tests during the implementation phase. But Veeva doesn't expect customers to simply trust us blindly; Veeva provides a full set of resources to document and track what exactly was tested, so customers (and regulators) can be assured that the applications are fully validated.

What does Veeva mean by prevalidation?

In traditional implementations, a customer may choose to perform installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) tests all on their own. The process of developing a master validation plan (MVP) through the entire user acceptance testing (UAT) stage can take a significant amount of time to design, test, refine, improve, and apply, especially for a new application and if these tests are being developed from scratch.

With Essentials, Veeva's qualification, testing, and validation approaches are aligned with industry best practices for computer system validation, and Veeva provides the documentation for all of the validation tests performed.

Veeva provides Essentials customers with all of the following documentation during the implementation period:

• Master validation plan (MVP)
• User requirements specification (URS)
• User acceptance testing (UAT) / performance qualification (PQ) test plan
• Executed UAT/PQ test scripts
• Traceability matrix (TM)
• Validation summary report (VSR)

Once a customer goes live with RIM Essentials, they become responsible for validation and may choose to execute their own UATs going forward. However, Veeva offers HyperCare (immediately after go live) as well as Managed Services (longer-term support) if companies would like to continue having Veeva support their validation efforts.

Why is prevalidation important?

By performing prevalidation tests, Veeva is taking a significant burden off of our customers, especially those small companies that do not have a lot technical support in-house.

Accepting Veeva's prevalidated solution not only allows these companies to go live on Veeva Vault RIM more quickly, it also enables them to use an industry-leading RIM solution to support their company growth and development. Since Vault RIM Essentials does not limit any capabilities, customers are able to access and use any feature after they go live. And, if any issues or questions arise afterward, Veeva is always available to help.

Do you still have questions about prevalidation for Vault RIM? If so, reach out to a sales representative, or take a look at our Veeva validation datasheet.