Core
$0Free plan available.
Introduction:
Enzyme QMS provides software modules covering the entire product development lifecycle, from Design Control to CAPA. The platform supports cGMP, QSR, and ISO standards, is 21 CFR Part 11 compliant, and comes validated out-of-the-box with various integrations. Designed to scale from startup to IPO, Enzyme offers expert guidance for regulatory submissions and adapts to the workflows of medical device, digital health, and biopharma companies.
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Enzyme QMS Product Information
What is Enzyme QMS?
Enzyme QMS software includes modules for all stages of the product development lifecycle, from Design Control to CAPA. In-house experts are available to assist users with quality challenges and regulatory submission processes. The software covers key components of cGMP, QSR, and ISO standards, is 21 CFR Part 11 compliant, and is validated out-of-the-box with numerous integrations. Built to scale, Enzyme supports the full product lifecycle for medical device, digital health, and biopharma companies, providing tools for premarket to postmarket needs.
How to use Enzyme QMS?
Enzyme QMS integrates with your existing tools, enabling you to import data and generate reports directly within the eQMS. You can select from Core, Premarket, or Postmarket plans tailored to your company's requirements, with specific options available for Full and Lite users.
Enzyme QMS's Core Features
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Document control
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Change control
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Training
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Design control
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Risk management
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Suppliers
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Audits
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Complaints
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Nonconformance
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CAPA
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21 CFR Part 11 compliance
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Integrations
Enzyme QMS Use Cases
#1
Streamlining quality processes and post-market compliance for medical device companies.
#2
Managing document control, change control, and training for biopharma companies.
#3
Ensuring audit readiness and maintaining an organized quality system for startups.
FAQ from Enzyme QMS
What stages of the product development lifecycle does Enzyme QMS cover? +
Enzyme QMS covers every stage of the product development lifecycle, ranging from Design Control to CAPA.
Is Enzyme QMS compliant with industry standards? +
Yes, Enzyme QMS is 21 CFR Part 11 compliant and covers the essential components of cGMP, QSR, and ISO standards.
What types of companies does Enzyme QMS serve? +
Enzyme QMS is designed for medical device, digital health, and biopharma companies.
Enzyme QMS Pricing
Premarket
$0Free plan available.
Postmarket
$0Free plan available.