The Goal

BASF AP has chosen Veeva as their strategic technology partner for digitizing data, documents as well as GLP and other controlled processes across some of their Regulatory and Quality functions. More than 1,650 R&D and regulatory experts can now access information in real time with highest performance. They rely on Veeva to simplify and automate their most demanding compliance and other processes, mainly in two areas:

• Creation and management of registration dossiers in crop protection and seeds – This includes creating and compiling dossiers as well as publishing them in accordance with the authorities’ requirements.
• GLP quality assurance – This involves everything from GLP document management and archiving, inspections of any kind and data management, to training documentation and handling of standard operating procedures (SOPs).

The need to comply with GLP is essential for BASF. Dr. Frank Schieweck, Head Global GLP Management at BASF explains: “Only studies conducted under GLP will be accepted by the registration authorities to get approval for a new crop protection product. They must meet certain quality criteria.” The decision to leverage a cloud-based solution like Veeva Vault wasn’t made easily. Rainer Becht-Mattern, Product Family Manager Europe - Agricultural Solutions, states: “In 2017, it was a brave decision to use a cloud-based Software as a Service (SaaS) offer, especially as we needed to ensure GLP compliance. Back in the days, inspectors were used to see servers onsite and we had our own on-premise data center for GLP studies. Going to the cloud was a courageous step.”

Courageous, yet necessary. The biggest advantages for the BASF team are the system’s availability, performance and continuous development alongside all benefits that come with a single source of truth. However, leveraging a cloud solution to manage controlled processes also required a change in mindset from the GLP monitoring authority. Government inspectors had to find new ways to inspect BASF’s solution, both on-site and remotely. To achieve this the inspectors worked closely with BASF, Veeva and data center operator Amazon Web Services (AWS) to validate the solution’s GLP compliance. As a result, BASF’s Veeva solution complies with GLP requirements - in terms of archiving as well as regarding inspectability, which is given throughout the process from user to server level. This was a huge milestone for the solution team.

By end of 2022, BASF AP has consolidated 15 legacy systems with their Veeva solution. It enables the IT team to support new business processes and ideas from their business teams. “Veeva was different from the start. Their industry and technical expertise impressed us. The Veeva platform does not only enable managing data and documents, but also lets us cover regulatory and quality processes in one fully integrated solution at a level that I haven’t seen elsewhere. The performance and user-friendliness as well as the continuous development were additional benefits,” states Rainer Becht-Mattern.