Enzyme
Quality management system software for life science companies covering document control, e
Enzyme is an electronic quality management system for life sciences companies, covering the key components of cGMP, the QSR, and ISO standards across the full product development lifecycle. It centralizes quality workflows that would otherwise be spread across multiple tools, from premarket design and risk activities through postmarket surveillance and compliance documentation. The platform is described as validated out-of-box and compliant with 21 CFR Part 11, and it is designed to support companies from startups through IPO.
The eQMS includes modules for document control, change control, training, design control, risk management, suppliers, audits, complaints, nonconformance, and CAPA, along with eTMF and eSignatures. It integrates with existing tools, supports data import, and generates reports directly from the system. A document library offers more than 80 SOPs, work instructions, quality manuals, and forms tailored to product types ranging from small molecule to digital therapeutic. The platform is available on Microsoft Office 365.
Enzyme is built for medical device, digital health, and biopharma companies, and is positioned for both startups and complex enterprises. Pricing is based on a selected plan — Core, Premarket, or Postmarket — and on the number and types of users, with Full and Lite user tiers available. The company was founded in 2017, is headquartered in South San Francisco, and has been acquired by Greenlight Guru.
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