Streamlining operations with cross-functional integration was a major theme at this year's Veeva R&D and Quality Summit Connect. Pacira's Marie Murtagh and Joy Piva were among the customer presenters who highlighted the potential efficiencies in sharing data, documents, and processes across domains. The regulatory leaders described how Pacira is improving its promotional material submissions process with a Veeva solution that combines Vault PromoMats and the Vault RIM Suite.
Fully Electronic Ad Promo Submissions Process
Pacira implemented Vault PromoMats four years ago to help medical, legal, and regulatory teams review and approve content faster. Murtagh called the application's digital process "absolutely amazing," especially compared to her previous experience with inefficient paper- and email-based approaches. During the pandemic, when remote workers didn't have access to high-speed printers, Vault PromoMats was a key part of Pacira's transition to a streamlined, all-inclusive electronic OPDP submission process-a full year ahead of the FDA's June 2021 deadline.
Commercial and Regulatory on the Same Platform
As Pacira's regulatory department grew, they needed to replace SharePoint with a secure, part 11 compliant system for collaborative authoring and submissions so they chose Vault Submissions, Vault Submissions Publishing, and Vault Submissions Archive to help them achieve those goals. Murtagh said the Vault RIM Suite was appealing because it shares Vault PromoMats' familiar interface and uses the same process for uploading documents. Pacira also sees advantages in managing promotional submissions together with their other regulatory submissions on the same Vault Platform. With the implementation of Vault RIM, "we're going to have a seamless, end-to-end process. Our systems will be unified," said Piva.
Leveraging a Vault Connection to Further Shorten Submission Timelines
Looking ahead, Pacira sees more opportunities to streamline its more than 650 annual OPDP submissions. Piva believes auto-generation of Form 2253 and the claims linking functionality in Vault PromoMats will be big timesavers. The company also expects to accelerate promotional material submissions with the Vault PromoMats to RIM Connection. This integration will automatically create the xml for the submission, link compliance package generation in Vault PromoMats to Vault Submissions, and will allow the regulatory team to publish directly to OPDP through the Vault Submissions Publishing gateway. "Instead of hitting email and two different systems, we will have an automation that will surely cut down hours and make us more efficient," Piva said.
To view the full Pacira session and other on-demand recordings from the R&D and Quality Summit Connect, visit Veevaconnect.com.
Veeva Systems Inc. published this content on 23 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 23 November 2021 22:09:10 UTC.