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Enzyme
Enzyme Employees
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Michelle Avila
Customer Success & Quality Solutions Manager
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Enzyme Company Information
Enzyme, headquartered in San Francisco with a fully remote operational model, specializes in healthcare IT within the healthcare industry. The company, which participated in Y-Combinator’s S17 batch, employs a team of 32 professionals with over 50 years of combined experience in the medical device sector. Enzyme provides a comprehensive online quality management system (QMS) software that is 21 CFR Part 11 compliant, validated out-of-box, and features an industry-leading number of integrations. This QMS supports the entire product lifecycle and automates regulatory approval and compliance processes for life science companies. In addition to its software solutions, Enzyme offers QA/RA consulting services and has various plans to meet different needs. The company also integrates with existing tools to facilitate easy data import and report generation, including a new integration with Microsoft Office 365. Enzyme is ISO 9001:2015 certified and SOC 2 Type II compliant, underscoring its commitment to quality and security. Trusted by major companies such as Pfizer, Roche, and Stryker, Enzyme continues to be a pivotal player in supporting healthcare innovations.
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