BASF + Veeva: Digital Change Control at BASF Personal Care

The video details the successful digital transformation of the Change Control process at BASF Personal Care Europe through the implementation of Veeva QualityOne. Iris Scheepers, Senior Manager for Quality Management Systems (QMS) and Audits, shares the company's journey, emphasizing the critical importance of managing changes efficiently and compliantly within a business adhering to GMP standards. The transformation was initiated specifically with change control due to its central role in the business, requiring meticulous documentation, risk management assessment, and tracking of change criticality.

Prior to the implementation, BASF struggled with manual change control processes, relying heavily on disparate systems like files and emails, which made follow-up difficult and obscured the overall status of changes. The core motivation for the shift was to centralize these processes. By moving to Veeva QualityOne, the team gained a "perfect overview" of all changes, including their current status (in work, closed), significantly enhancing transparency and control. This centralization not only improved efficiency but also boosted team morale and motivation, as employees could easily visualize the collective impact of their work over time.

The implementation methodology involved comparing BASF's existing, clear workflow against the standard change control workflow provided by Veeva. This comparison allowed the team to adapt the standard solution to their specific needs, resulting in a reduction of procedural steps. This streamlining made the entire process simpler to overview and ultimately led to greater overall efficiency. A key outcome of the digital system was the ability to easily retrieve historical data and demonstrate compliance by simply pressing a button, a significant advantage for audit readiness.

Scheepers concludes by offering valuable advice for organizations embarking on similar digital transformations. She stresses the importance of clarity regarding initial objectives but cautions against striving for immediate perfection, advocating instead for adaptability and continuous learning from the organization's experience. Crucially, the digital platform facilitated organic integration of related QMS functions; employees quickly recognized the potential to connect risk management and audit reports directly to the change control process, making the system more comprehensive and driven by user needs.

Key Takeaways: • Change Control as a Foundational Transformation Pillar: BASF strategically chose change control as the starting point for their digital transformation due to its absolute importance in a regulated business, its linkage to risk management, and the need to document compliance with GMP standards. • Overcoming Manual Process Deficiencies: The shift addressed the inherent difficulties of manual change control, which involved tracking changes across decentralized files and emails, leading to poor follow-up and lack of visibility into the current status of changes. • Achieving Centralized Visibility and Control: Implementing a unified system like Veeva QualityOne provides a "perfect overview" of all changes, allowing users to instantly see the status (closed, in work) and track the history of changes executed over time, significantly aiding management and audit preparedness. • Boosting Employee Motivation and Adoption: The improved user-friendliness and clear visibility offered by the digital system led to high enthusiasm and adoption among the team, demonstrating that efficiency gains can directly contribute to increased employee motivation. • Workflow Optimization through Comparison: The implementation strategy involved comparing the company's existing workflow against the standard workflow offered by the solution provider (Veeva). This comparative analysis allowed BASF to adapt the system and successfully reduce the number of procedural steps, saving time and simplifying the overall process. • Prioritize Clarity over Perfection: A key recommendation for starting a digital transformation is to be very clear about the initial goals, but not to expect immediate perfection. Organizations should embrace adaptability and plan to learn and evolve the system based on organizational feedback and practical application. • User-Driven System Integration: The digital platform fostered organic connections between critical QMS functions. Employees who worked directly with the tool recognized and implemented connections between change control, risk management, and audit reporting, making the system more robust and integrated based on real-world needs. • Focus on Efficiency and Simplicity: The ultimate goal of the transformation was to increase efficiency and simplify the overview of the entire change control process, ensuring that the system saves time while maintaining regulatory rigor.

Tools/Resources Mentioned:

• Veeva QualityOne: The specific software platform used by BASF Personal Care for implementing digital change control.

Key Concepts:

• Change Control: A formal process used to manage all changes to systems, processes, or products in a regulated environment (like pharmaceuticals or personal care) to ensure that changes are necessary, documented, risk-assessed, and approved before implementation.
• GMP Standard (Good Manufacturing Practice): A system for ensuring that products are consistently produced and controlled according to quality standards. Adherence to GMP requires rigorous documentation and management of quality systems, including change control.
• Quality Management System (QMS): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives, often encompassing audits, risk management, and change control.