Technology Category
- Application Infrastructure & Middleware - Data Exchange & Integration
- Platform as a Service (PaaS) - Application Development Platforms
Applicable Industries
- Electronics
- Life Sciences
Applicable Functions
- Quality Assurance
Use Cases
- Leasing Finance Automation
- Regulatory Compliance Monitoring
Services
- System Integration
About The Customer
Pacira is a pharmaceutical company that is committed to driving innovations to provide better ways to safely and effectively manage pain. The company is focused on the development and commercialization of novel products that address important unmet medical needs in acute care settings. Pacira's regulatory department is responsible for ensuring that the company's products meet all necessary regulatory standards and requirements. The department was looking for a solution that could streamline their promotional material submissions process and provide a secure, part 11 compliant system for collaborative authoring and submissions.
The Challenge
Pacira, a pharmaceutical company, was facing challenges in streamlining its promotional material submissions process. The company was using inefficient paper- and email-based approaches that were not only time-consuming but also lacked the necessary speed and efficiency. The situation was further exacerbated during the pandemic when remote workers did not have access to high-speed printers. Additionally, as Pacira's regulatory department grew, they needed to replace SharePoint with a secure, part 11 compliant system for collaborative authoring and submissions. The company was also looking for a solution that could manage promotional submissions together with their other regulatory submissions on the same platform.
The Solution
Pacira implemented Veeva's Vault PromoMats four years ago to help medical, legal, and regulatory teams review and approve content faster. The digital process provided by Vault PromoMats was a significant improvement over the previous paper- and email-based approaches. The solution was instrumental in Pacira's transition to a streamlined, all-inclusive electronic OPDP submission process, a full year ahead of the FDA’s June 2021 deadline. To further enhance their regulatory processes, Pacira replaced SharePoint with Vault Submissions, Vault Submissions Publishing, and Vault Submissions Archive. These solutions provided a secure, part 11 compliant system for collaborative authoring and submissions. The Vault RIM Suite was particularly appealing as it shared Vault PromoMats’ familiar interface and used the same process for uploading documents.
Operational Impact
Quantitative Benefit
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