Enzyme

What it does

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.

Core features

• ✦Document control
• ✦Change control
• ✦Training
• ✦Design control
• ✦Risk management
• ✦Suppliers
• ✦Audits
• ✦Complaints
• ✦Nonconformance
• ✦CAPA

Use cases

• →Streamlining quality processes and post-market compliance for medical device companies.
• →Managing document control, change control, and training for biopharma companies.
• →Ensuring audit readiness and maintaining a well-organized quality system for startups.