Enzyme is a quality management system and a regulatory submission platform that provides companies with the complete solutions that they need. The software includes modules for all stages of the product development life cycle from Design Control to CAPA. Enzyme’s QMS includes modules that cover the key components of 21 CFR 820 and ISO 13485. The software features design control, document control, training, complaints, audits, suppliers, Nonconformance and corrective & preventive action, accordingly. Enzyme’s QMS is designed for use in a modern, agile software development process. One can import existing data into Enzyme so they don’t have to repeat the work. Furthermore, one can generate reports directly from Enzyme which can be used for submission. Enzyme's objective is to enable life sciences organisations to develop more effectively and quickly. The platform supports the development and commercialisation of digital, drug-device combination, diagnostic, software/hardware, and disposable healthcare products. The platform guarantees that a product is properly verified and validated prior to design transfer and submission, lowering the risk of rework and project churn.
Pricing
Platforms Supported
Organization Types Supported
API Support
Modes of Support
Free Trial
Not available
Pricing Options
Premium Plans ( Quotation Based )
Pricing Plans
Enzyme Custom
Features
Disclaimer: The pricing details were last updated on 16/09/2020 from the vendor website and may be different from actual. Please confirm with the vendor website before purchasing.
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Enzyme QMS
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What are the top alternatives for Enzyme?
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Does Enzyme provide API?
No, Enzyme does not provide API.
Vendor Details
San Francisco, California Founded : 2016Contact Details
Not available
https://www.enzyme.com/
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