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Yes. Enzyme ships as a pre-validated platform with electronic signatures, audit trails, and access controls aligned to 21 CFR Part 11. Customers receive validation documentation they can present during FDA inspections or notified body audits, which significantly reduces the internal IQ/OQ/PQ effort typically required when deploying a new QMS.
Enzyme is built to support FDA 21 CFR Part 820 (QSR), ISO 13485 for medical devices, ISO 14971 for risk management, EU MDR and IVDR, and ISO 9001. It is suitable for medical device, IVD, biotech, and pharmaceutical organizations operating under these frameworks.
Enzyme primarily serves life sciences companies — medical device manufacturers, diagnostic developers, biotech firms, and pharmaceutical organizations — ranging from early-stage startups preparing for their first regulatory submission to established manufacturers scaling postmarket quality operations.
Because the platform is pre-validated and ships with life-sciences-ready templates, implementations are generally measured in weeks rather than the multi-quarter rollouts associated with traditional enterprise QMS systems. Enzyme also pairs customers with quality and regulatory experts during onboarding to accelerate setup.
Enzyme positions itself between Greenlight Guru's startup-focused simplicity and the enterprise depth of MasterControl and Veeva Vault. It offers broader lifecycle coverage and bundled regulatory consulting that Greenlight Guru does not, while being faster and lighter to deploy than the legacy enterprise platforms — at the cost of a smaller integrations ecosystem and less deep configurability.
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