generated: '2026-07-19'
method: searched
source: https://www.enzyme.com/
standards:
- id: soc2-type-ii
  conforms: true
  evidence: SOC 2 Type II badge published in the enzyme.com site footer
- id: 21-cfr-part-11
  conforms: true
  evidence: Platform advertised as "21 CFR Part 11 compliant, validated out-of-box" on enzyme.com/product
- id: iso-13485
  conforms: false
  evidence: Not published; Enzyme is a QMS for medical-device makers but does not claim its own ISO 13485 certification
notes: >-
  Enzyme is an electronic Quality Management System (eQMS) for life sciences. Its
  published assurance posture is SOC 2 Type II plus FDA 21 CFR Part 11 electronic
  records/signatures compliance. No public API/OpenAPI is available, so no
  API-level (oauth2/oidc/rfc9457) conformance could be derived.