Industry Challenges
In the biopharma industry, change control is a critical but complex process that involves multiple stakeholders. Each year, numerous changes are made to approved products, with many of these changes having regulatory implications. Regulatory teams are tasked with assessing these impacts through a separate variation management process and then seeking approval from health authorities worldwide. Traditionally, quality and regulatory teams manage these processes using disjointed methods such as emails and phone calls, which can lead to transparency issues, compliance challenges, and delays in product distribution.
The Solution
To address these challenges, Veeva has introduced the Vault Quality to RIM Connection. This innovative solution aims to streamline change control and variation management processes by providing users with real-time visibility into health authority approvals. The bidirectional process flow facilitates a seamless transition from change request creation in Vault QMS, through impact assessments, to authorization and execution. Affiliates can then initiate health authority filings and track their progress within the system, ensuring that all stakeholders are aligned throughout the process.
Benefits
The Vault Quality to RIM Connection represents Veeva"s commitment to driving efficiency and innovation in quality and regulatory processes. By offering complete impact intelligence and enhanced visibility, teams can make more informed decisions and significantly reduce the timeline from change control initiation to implementation. This increased transparency also enables teams to mitigate regulatory risks, manage inventory effectively, and prevent delays in product distribution. Ultimately, Veeva"s solution empowers organizations to operate more efficiently and compliantly in today"s fast-paced regulatory environment.
Conclusion
Veeva"s Vault Quality to RIM Connection is a game-changer for biopharma companies looking to enhance their change control and variation management processes. By centralizing these critical functions and providing real-time visibility, Veeva empowers teams to collaborate effectively, make informed decisions, and streamline operations. With a focus on innovation and efficiency, Veeva continues to set new standards in the industry, helping organizations navigate complex regulatory landscapes with confidence and compliance.