Enzyme QMS

Enzyme QMS is a validated Quality Management System for life sciences companies, priced via custom sales quotes typically starting around $50,000 per year for small teams and scaling into six figures for larger organizations. The platform is purpose-built for medical device manufacturers, biotechnology firms, diagnostic developers, and pharmaceutical companies that need 21 CFR Part 11 compliance without months of internal validation effort. Unlike traditional QMS platforms like MasterControl or Veeva Vault that commonly require multi-quarter implementation and separate validation services, Enzyme delivers a pre-validated environment with electronic signatures, audit trails, and access controls ready on day one. Customers receive validation documentation suitable for FDA inspections and notified body audits, significantly reducing IQ/OQ/PQ burden. The platform covers the full product lifecycle in a single system: design controls, risk management, document control with automated approval workflows, training management, CAPA, complaints handling, and supplier qualification. Enzyme also bundles hands-on regulatory and quality consulting during onboarding, pairing customers with domain experts to build templates, SOPs, and processes tailored to their regulatory pathway — whether 510(k), De Novo, PMA, or ISO 13485 certification. AI-assisted capabilities support document drafting, compliance gap detection, and routine quality workflow acceleration. Native integrations with platforms like Benchling, Jama Connect, LabVantage LIMS, and Salesforce connect quality processes to existing R&D and commercial tooling, with a REST API available for custom integrations.