AmplifyBio Advances Compliance And Their Digital Strategy: One Step Closer To Realizing Pharma 4.0

AmplifyBio, a drug development and commercialization partner for advanced therapies, provides industry-leading preclinical toxicology, safety, and pharmacology testing, in addition to expert drug discovery, optimization, characterization, and manufacturing services. AmplifyBio wanted to identify areas of its operation where digitalization could yield ROI in a short amount of time. The company focused on optimizing and digitizing routine tasks such as harmonizing regulatory asset management, streamlining calibration and maintenance procedures, and ensuring 21 CFR Part 11 compliance of all spreadsheets with a click of a button. As a result, AmplifyBio's goal was to replace their paper-based systems with a single 21 CFR Part 11 compliant electronic system that would both eliminate manual interventions and mitigate regulatory, quality, compliance, and data integrity risks while improving efficiency.

Due to the complexity of the project, AmplifyBio, Verista, and Blue Mountain collaborated to implement well-established guidelines that aligned with Pharma 4.0. This approach consisted of four key elements: strategy, technology, process, and people, operating seamlessly and synergistically without constraints. Gain insight into the out-of-the-box solution as well as how the interactions between the Blue Mountain RAM and the Veeva QMS environments were identified and streamlined.