Enzyme Introduction
What is Enzyme?
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.
How to use Enzyme?
Enzyme QMS integrates with existing tools, allowing users to easily import data and generate reports directly from the eQMS. Users can choose from Core, Premarket, or Postmarket plans based on their company's needs, with options for Full and Lite users.
Why Choose Enzyme?
Go for this if you need a quality management system powered by AI that streamlines your workflows and keeps everything compliant and on track.
Enzyme Features
Other
- ✓Document control
- ✓Change control
- ✓Training
- ✓Design control
- ✓Risk management
- ✓Suppliers
- ✓Audits
- ✓Complaints
- ✓Nonconformance
- ✓CAPA
- ✓21 CFR Part 11 compliance
- ✓Integrations
FAQ?
Pricing
Core
Document control, Training, eSignatures, Integrations
Premarket
Document control, Training, eSignatures, Integrations, Design control, Risk management, Suppliers
Postmarket
Document control, Training, eSignatures, Integrations, Design control, Risk management, Suppliers, Audits, Complaints, Nonconformance, CAPA
