For the life sciences industry, collaboration between different functional areas such as the regulatory and clinical teams is essential to ensuring the successful launch of a new product. Yet, too often each functional area has its own set of different systems which cause them to operate in silos. Seamless integration of these heterogeneous systems demands a complex middleware which often becomes a costly affair in terms of time, effort, and financial commitment. What if an enterprise platform was built to integrate applications across quality, clinical, regulatory, commercial, training and safety? We performed a case study with Veeva Vault applications and found the following.
Veeva Vault Connections are integrations that enable different functional areas of your organization to transfer data and documents between the following applications: Vault Clinical Operations, Vault CDMS, Vault Quality, Vault RIM, Vault Safety and Vault PromoMats. These connections enhance collaboration, provide functional areas with visibility into each other’s work and enable automation of manual tasks.
The Vault Clinical Operations to RIM integration enables the sharing of product, study and site data between clinical and regulatory teams. This ensures clinical teams are using the most recent version of documents for eTMF inspections. Regulatory teams can reduce the compliance risk from human error through this integration as it decreases the need for duplicate data entry and document uploads.
The Vault Quality to RIM Connection integrates data for the quality and regulatory functional areas, decreasing the time needed for change control. Through this integration there is greater transparency into both sides of this process, reducing compliance issues and helping to avoid product distribution delays.
The Vault CDMS to Clinical Operations connection enables the clinical data management and clinical operations teams to automate the transfer of their data, reducing human error and eliminating duplicate data entry.
The Vault PromoMats to RIM integration enables commercial and regulatory teams to share information within Vault, reducing the time needed to submit promotional materials to regulatory authorities.
Through the Vault Connections, process redundancies are eliminated, and collaboration is increased. These Connections have great potential for breaking down silos between the quality, clinical, regulatory, commercial, training and safety functional areas of a life sciences organization. If you would like to learn more about our case study, please contact the Prana Life Sciences team to speak with one of our Veeva Vault experts who has a background in this area.
Reference:
