Customer

This US-based pharmaceutical company was recently acquired by one of the largest pharmaceutical companies in the world by revenue.

Background

Facing an acquisition by one of the largest pharmaceutical companies in the world, a US-based pharmaceutical company needed a formal, enterprise-class records management system, not only to handle the higher volume of records, but to also meet all FDA and GLP (Good Laboratory Practices) regulations. Previously, the company relied on Excel spreadsheets and shared drives to manage its records and information. This created critical process and compliance challenges.

With the help of Gimmal’s Physical Records, this client can maintain compliance with FDA regulations and GLP.


Challenges

  • The lack of an automated records management solution resulted in inability to handle high volumes of new records from new sources

  • There were inconsistent processes between users and an inability to search all available records in a timely manner

  • The client had difficulty locating the most up-to-date records due to lack of unified version control between users

  • There was a backlog of inherited records due to rapid mergers, acquisitions, and divestitures (MAD)

  • There was a time-consuming and costly validation process

Results

  • Compliance with FDA regulations and Good Laboratory Practices (GLP)

  • Greater visibility and control over all records, even during mergers, acquisitions, and divestitures

  • Improved inventory workflow with bulk import and export functionality

  • Tracked record status throughout the entire Quality Control process

Want to learn more ?

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