Client Profile:
AmplifyBio is a drug development and commercialization partner for advanced therapies. They provide industry-leading preclinical toxicology, safety, and pharmacology testing, along with expert drug discovery, optimization, characterization, and manufacturing services.
Challenge:
AmplifyBio sought to identify areas of their operation where digitalization of their processes would deliver an ROI in a short amount of time. Digitizing everyday activities like harmonizing regulatory asset management, streamlining calibration and maintenance, and making every spreadsheet 21 CFR Part 11 compliant with a click of a button were attractive areas to optimize. As a result, AmplifyBio wanted to replace their paper-based systems with a single 21 CFR Part 11 compliant electronic system that would eliminate manual touches, and thereby mitigate regulatory, quality, compliance and data integrity risks while improving efficiency.
Solution:
The Verista team partnered with AmplifyBio SMEs to identify and streamline the interactions between the Blue Mountain RAM and the Veeva QMS environments. This provided clarity on what system would serve what purpose and when it would be needed in the workflows.
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