About the Client
One of the world's largest pharmaceutical businesses by revenue, the US-based company has a diversified portfolio of prominent brands across products such as medicines, vaccines, and consumer health care.
The company has to comply with the FDA’s Good ‘X’ Practices (GXP), as well as to cyber security norms. Non-compliance can result in not just large fines, but also a weakened brand image.
However, the company currently used disparate IT tools to automate various compliance processes, which precluded an enterprise-wide view of compliance. What’s more, these applications were not scalable, and resulted in higher compliance costs as well as a bigger risk of regulatory breaches.
Therefore, the drug major decided to leverage TCS’ extensive expertise in GRC to implement an effective solution.
Following an analysis of the pharma company’s existing IT landscape, TCS developed a blueprint for an integrated, on-demand compliance management system. Algorithms built into the solution, based on the RSA Archer eGRC suite, identified the full range of norms applicable to any given situation. Through robust process orchestration, TCS integrated the compliance management system with all other dependent applications. In conjunction, smooth data migration was carried out to ensure business continuity.
With the new holistic compliance management system, the pharmaceutical giant can anticipate potential lapses concerning regulatory compliance and take mitigating measures in time.
The drug major also reduced the processing time associated with compliance by 50%, as the web-based, user-friendly system automatically identifies requirements and self-compiles related data from enterprise applications.
The new solution facilitates enhanced control over regulatory assessments by issuing on-demand alerts about compliance-related tasks. Moreover, the firm’s management team has gained greater visibility into organization-wide compliance processes with the help of business reports generated by the system.