Business Challenge
A global pharmaceutical company sought to reduce contractor spend on their global product quality complaints system. The system processes and documentation were not sufficient to transition support to another supplier. The complaints system needed to be modified to support timely reporting for product quality complaints to health authorities for future regulations. The client struggled to elicit and document the processes and requirements to support a future-stand complaint system with new regulations from current contractors.
Solutions
Experis leveraged our knowledge of best practices for Agile development and documentation to align internal SDLC processes. We facilitated business process and business requirements gathering sessions with disparate group of stakeholders representing multiple business units, geographies and user roles. Afterwards, our team utilized and updated a process baseline framework to organize requirements. Throughout the process, our team acted as the liaison between the business owners, IT team members, project approvers, and external system vendors to ensure consistency of requirements across the project work streams.
Results
Our team developed and documented over 200 comprehensive user requirements validated by the project approvers under aggressive time frame. Additionally, we reduced the risk of late reporting to the FDA and eliminated risk of incomplete or missed product quality complaints by properly documenting process and functional requirements for regulatory compliance. Working with Experis, enabled an anticipated reduction of $5M/year in spend for staff augmentation and contractor spending for our client.
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