Vitrana’s TransformPVTM, the preferred solution for meeting R3 requirements recently went live at biggest Pharma organization in the world. Despite the significant complexities the implementation went very smoothly and implementation was achieved within a timeframe of 10 months. In current scenario with a defined FDA Guidelines and no major updates expected, the TransformPVTM implementation can be managed through an accelerated approach and can be accomplished between 3-5 months based on the chosen validation methodology.
TransformPVTM is the only solution in the market to have successfully gone live with both Vaccine R3 and Device HL7 reporting.
Since the go-live there have been hundreds of successful submission to FDA VAERS and eMDR.
During the course of the project there were significant updates introduced in the guidance, but due to design of TransformPVTM platform there was minimal impact of these updates and we were to able turnaround with updated solution within weeks instead of months.
As we look back at this significant milestone, there are few critical success factors we would like to share for organizations who are planning or in process of implementing an R3 capable solution:
Detailed requirements Assessment
Close coordination with regulatory agency
Here’s some interesting details from the last implementation:
TransformPVTM platform allows organization to manage their R3 compliance needs without significant investments and allows them to focus on more pressing needs. The platform is scalable to meet future requirements and comes with features like R3 only viewer, R2-R3 view for transmissions, Integration with LDAP and Documentum.