Enzyme QMS

Enzyme QMS

Enzyme
Qualcy QMS

Qualcy QMS

Qualcy Systems
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About

A QMS that includes modules for all stages of the product life cycle from Design Control to CAPA. We train your entire team and provide you with support when and as it's needed. Enzyme Consulting, LLC. can support you in customization and implementation your Quality System. After your onboarding, Enzyme’s team is available for follow up calls and to answer your questions. Enzyme's QMS is built by industry veterans frustrated by existing QMS solutions. We designed it for all life science companies, paying particular attention to the challenges building FDA-regulated software. Deliver your product to market with confidence with the help of our dedicated consultants. Bolstered by first-hand experience working in the medical device industry and an acute aptitude for accurately assessing risk, our consultants empathize with the challenges of navigating the product development lifecycle.

About

Qualcy Bio-Med QMS Software has been designed for Bio-Medical companies (including Biotech, Pharma and Medical Device) to manage QMS records for ISO13485 and FDA requirements. * Designed for meeting the requirements for 21 CFR Part 820 * Has built in features for E-sign, audit trails and complies with 21 CFR part 11 requirements. This software helps manage the records for Doc. change control, complaints, audits, CAPA, NC Records, Training Records and more.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Organizations looking for a Quality Management system and regulatory submission platform

Audience

Bio-Medical companies (including Biotech, Pharma and Medical Device)

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

$799 per month
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Overall 5.0 / 5
ease 5.0 / 5
features 5.0 / 5
design 4.0 / 5
support 5.0 / 5

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Enzyme
Founded: 2016
United States
www.enzyme.com

Company Information

Qualcy Systems
Founded: 2014
United States
www.qualcy.com

Alternatives

Alternatives

Total Lean Management (TLM) Software

Total Lean Management (TLM) Software

Lean & Mean Business Systems
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
isoTracker Quality Management

isoTracker Quality Management

isoTracker Solutions Ltd

Categories

Categories

Quality Management Features

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Calibration Management Features

Calibration Instructions
Calibration Schedules
Compliance Management
Device History
Due Date Tracking
Gage Management
Label Printing
Measurement Readings
Multi-Station Management
Out-of-Tolerance Notification
Statistical Data Reporting

Integrations

AWS Backup
AWS Cloud9
GitHub
Gmail
Jenkins
Jira
Microsoft 365
Microsoft Azure
Microsoft Outlook
SAP Analytics Cloud

Integrations

AWS Backup
AWS Cloud9
GitHub
Gmail
Jenkins
Jira
Microsoft 365
Microsoft Azure
Microsoft Outlook
SAP Analytics Cloud
Claim Enzyme QMS and update features and information
Claim Enzyme QMS and update features and information
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