Safety, reporting, regulation – Capgemini supports pharma clients with customized and validated solutions


Client: Global pharmaceutical company
Region: Europe
Client challenge: A global pharmaceutical company identified issues in its existing systems such as numerous manual steps and lack of effective interfaces with other applications in the pharmacovigilance ecosystem. Additionally, workflows were not optimized for efficiency and open to errors.
Solution: Capgemini delivered an automated, dynamic, user-friendly, and web-based application that reduces manual effort significantly and enhances process efficiency as well as user experience.
• An efficient and automated solution with regulated user access that is validated according to good practice (GxP) regulations
• Iterative development with multiple touchpoints with the business for continuous alignment
• Capable of being hosted on the client’s cloud infrastructure
• Modular structure, flexible for future expansion

Manual processes addressed by digital technology

Digital technology has increasingly ushered in a new era of business development that has simultaneously put pressure on previous leaders to evolve in order to remain a step ahead while also offering an opportunity to realize massive benefits. The client, like other global pharmaceutical companies, is subject to multiple regulatory authorities with an ever-increasing complexity in required reports. The over-reliance upon manual processes did not support required regulations, leading the client to decide to optimize workflows and ensure their regulatory long-term compliance.

It was decided to build a web-based application that could automate a variety of processes, such as regulatory-compliant access tracking (audit trails), reporting plans and the creation of a central retrieval point for long-term tracking of a product throughout its lifecycle. The organization selected Capgemini as a partner with expertise both within digital technology and application landscape management. Together they launched a collaborative effort to identify the core challenges and design a solution to address them.

A tailored application solution

Via a series of workshops hosted by Capgemini and involving user groups from across the organization key requirements were identified. Through these events the partners determined the exact nature of the pharmaceutical company’s key obstacles as well as the expectations and user-centric requirements .

Utilizing an iterative, incremental developmental plan, the partners designed a fully customized NET-based green-field solution that leveraged tools, hardware, software, and hosting services that were already present in the organization’s architecture. By sharing common interfaces with surrounding IT assets, the resulting application was seamlessly integrated into the existing IT architecture.

Working together – success and benefits for the business

With this software the organization and Capgemini have facilitated access to information, optimized report planning, and provided a validated and auditable environment. This has ensured greater transparency and compliance with regulatory requirements while simultaneously improving the company’s ability to effectively distribute resources

Through this project, the pharmaceutical company has demonstrated its willingness to transform in order to empower its employees and optimize daily workflows. Going forward, the organization and Capgemini will continue to look for further opportunities to develop impactful applications based on digital technology and in doing so pursue an agenda of constant innovation.

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