About This Site
Enzyme QMS is a quality management system software for life sciences companies. Enzyme QMS software includes modules for all stages of the product development life cycle from Design Control to CAPA. Their in-house experts are available to guide users through quality challenges and the regulatory submission process. Enzyme QMS software covers the key components of cGMP, the QSR, and ISO standards, and all stages of the product development lifecycle. It is 21 CFR Part 11 compliant, validated out-of-box, and offers an industry-leading number of integrations. Designed to scale as companies scale, Enzyme supports the full product lifecycle, serving medical device, digital health, and biopharma companies. Enzyme QMS has everything needed from premarket to postmarket, startup to IPO, and adapts to the user's way of working.
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Key Features AI
Core Features
Document control
Change control
Training
Design control
Risk management
Suppliers
Audits
Complaints
Nonconformance
CAPA
21 CFR Part 11 compliance
Integrations
Advantages
Covers all stages of the product development lifecycle
Compliant with key industry standards (cGMP, QSR, ISO, 21 CFR Part 11)
Scalable design to support growth from startup to IPO
Integrates with existing tools
User-friendly system with rapid document loading
Expert support team
缺点：Pricing not transparently listed on the website (requires contacting for pricing)
缺点：May require some configuration to meet the needs of complex enterprises
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