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PRODUCTOut-of-the-box QMS solution

Enzyme eQMS modules cover the key components of cGMP, the QSR, and ISO standards, and all stages of the product development lifecycle.

Document control

Intuitive document management that doesn’t lock you in

Change control

Centralize change management throughout your QMS

Design control

Take the document wrangling out of design control

Training

Ensure your training records are audit-ready 24/7

Risk management

Manage risk across the total product lifecycle

Suppliers

Simplify your supplier management process

Audits

Plan, conduct, and track your audits with ease

Complaints

Meet your postmarket surveillance requirements efficiently and effectively

Nonconformance

Identify, investigate, and resolve instances where a product, service, or process falls short

CAPA

Stay on top of quality issues to maintain compliance
Document control

Intuitive document management that doesn’t lock you in

Change control

Centralize change management throughout your QMS

Design control

Take the document wrangling out of design control

Training

Ensure your training records are audit-ready 24/7

Risk management

Manage risk across the total product lifecycle

Suppliers

Simplify your supplier management process

Audits

Plan, conduct, and track your audits with ease

Complaints

Meet your postmarket surveillance requirements efficiently and effectively

Nonconformance

Identify, investigate, and resolve instances where a product, service, or process falls short

CAPA

Stay on top of quality issues to maintain compliance

Work your way with Enzyme QMS

Designed for modern workflows, Enzyme's quality management system integrates with your existing tools so you can easily import your data. You can also generate reports directly from our eQMS.

Get started with
Enzyme's document library

Enzyme offers a complete set of 80+ SOPs, work instructions, quality manuals, and forms specific to your product type, from small molecule to digital therapeutic, for your quality management system.
Comparing how we did QMS at GeneWEAVE without Enzyme and how we do things now is night and day.
Diego Rey, Chief Scientific OfficerEndpoint Health
The team at Enzyme has helped us streamline our quality process and post-market compliance, including our QMS process. Their level of professionalism and service has been outstanding.
Enhao Gong, CEOSubtle Medical
The care and thought the Enzyme team has put into designing and implementing the eQMS has made our lives one thousand times easier.
Judy Brimacombe, VP Clinical, QA, RADawnLight Technologies

Electronic Quality Management System

Enzyme eQMS is flexible and scalable, making it easy to use for startups, yet configurable to meet the needs of the most complex enterprise

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