Bharat Biotech Transforms Quality Management with AmpleLogic eQMS

Customer Story

Bharat Biotech Transforms Quality Management with AmpleLogic eQMS

Bharat Biotech, established in 1996 and headquartered in Hyderabad, India, is a global leader in biotechnology and vaccine innovation. Renowned for its pioneering contributions, such as the development of Covaxin, Bharat Biotech has earned a reputation for excellence in research, manufacturing, and distribution. With over 20 vaccines in its portfolio and operations spanning 125 countries, the company is vital in enhancing global healthcare standards.

Bharat Biotech is committed to innovation and compliance. It operates state-of-the-art manufacturing facilities and is backed by a team of more than 3,000 professionals. These facilities produce billions of vaccine doses annually and adhere to stringent international regulatory standards, including WHO prequalification and GMP certification.

Challenges

As Bharat Biotech scaled its operations and expanded into global markets, its existing quality management processes struggled to keep pace. The challenges included:

Process delays: Manual document control and CAPA processes created bottlenecks in approvals and escalations, impacting turnaround times.
Dispersed data management: Lack of an integrated system resulted in fragmented quality data across departments, reducing transparency and operational efficiency.
Compliance risks: Managing a wide range of regulatory requirements across geographies, including FDA, WHO, and GMP guidelines, was labor-intensive and prone to errors.
Limited audit readiness: Manual tracking systems made ensuring complete and accurate data availability during audits challenging, increasing the risk of non-compliance.

To learn how Bharat Biotech leveraged AmpleLogic eQMS to enhance quality, streamline compliance, and achieve operational excellence, fill out the form below to download the entire case study!