Product and process compliance are essential for BASF AP. Their global team of R&D and regulatory experts manages complex, data and document intensive processes. In 2017, they reached a limit with their legacy environment: “We had a large number of legacy systems, globally distributed. We needed to store documents multiple times in different systems and could not ensure data was immediately available in all regions globally,“ remembers Armin Sauer, Team Leader Regulatory IT Services. The performance issues were a burden for the team.
BASF AP sought a flexible, future-proof, GLP-compliant solution to break down information silos, continuously improve processes, increase collaboration, enable data-based decisions and streamline compliance.
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:
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.
“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.”
Product Family Manager Europe - Agricultural Solutions, BASF
“For us, it was very important to break down information silos as well as standardize and simplify processes. We wanted everything to be accessible in all regions in real time. We have achieved all that. Veeva has been a great partner,” says Armin Sauer.
By now, BASF’s IT strategy has changed to a cloud first approach. Rainer Becht-Mattern explains: “We have the trust and confidence now that we can handle confidential data in the cloud just as securely or maybe even better than with on-premise solutions. With AWS and Veeva as strategic partners, we have also grown strongly in recent months and years.”
The initial plan was to harmonize 7 legacy IT systems by implementing the Veeva platform. However, by the time the solution went live, 11 systems had been replaced. Today the total number is 15, and BASF won’t stop there. They are evaluating Veeva for additional business units and business functions like production and operations.
“For our Veeva platform in AP, we are looking into connecting other cloud services to our solution - for example, a translation service that automatically translates our documents into all the languages we need”, states Rainer Becht-Mattern. The team is always looking into new ways to increase efficiency even further.
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