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Bharat Serum’s Journey with APQR Software

Bharat Serums and Vaccines (BSV) is a leading biopharmaceutical company in India, founded in 1971, focused on developing innovative treatments in critical therapeutic areas such as women’s health and critical care. With a strong commitment to enhancing quality of life, BSV’s extensive product portfolio includes biological, biotech, and pharmaceutical products, serving both domestic and international markets.

Challenges

  • BSV had a major challenge in manual APQR process which involves manual collection and analysis of data and manual APQR report creation.
  • This practice is prone to errors, could lead to data and document loss and could
    result in delays in report submission.

This disadvantages led to delayed Annual product quality review process, lack of proper authentication and verification, issues with regulatory compliances.

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