Pharmaceutical multinational ensures faster,complete adherence to FDA norms through an automated compliance management solution

A US-based pharmaceutical major realized the need for a robust compliance management system to effectively monitor enterprise-wide regulatory issues, and ensure compliance with FDA norms. The company collaborated with TCS to implement a centralized, web-based Governance, Risk, and Compliance (GRC) solution that facilitated 100% adherence to FDA guidelines.
 

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.

Business Challenge

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.

TCS’ 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.

Results

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.

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