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Description
Our Quality Management System (QMS) encompasses comprehensive modules that cover every phase of the product life cycle, ranging from Design Control to Corrective and Preventive Actions (CAPA). We empower your entire workforce through training and are ready to assist you whenever necessary. Enzyme Consulting, LLC. specializes in tailoring and implementing your Quality System to meet your specific needs. Once you complete your onboarding process, our team remains accessible for follow-up discussions and to address any inquiries you may have. Created by seasoned industry professionals who were disillusioned with current QMS options, Enzyme's system is specifically designed for life science companies, with a strong focus on the unique hurdles of developing FDA-regulated software. With the support of our committed consultants, you can bring your product to market with assurance. Our consultants possess not only direct experience in the medical device sector but also a keen ability to evaluate risks accurately, allowing them to truly understand and relate to the challenges faced during the product development journey. This level of support ensures that you are not alone in navigating these complexities.
Description
QFacts is a comprehensive cloud-based Quality Management System designed specifically for pharmacies, compounding facilities, and other regulated sectors. It encompasses the entire quality lifecycle, featuring controlled document management with versioning and approval workflows, training and competency tracking with curriculum-aligned assignments, as well as event and complaint management, root cause analysis, CAPA oversight, and change control, all accompanied by thorough audit trails. This system is built to comply with GAMP 5 and adhere to European GMP and GDP standards, employing role-based access controls that span organizations, locations, and departments. Quality managers can customize review workflows, keep track of due dates, and oversee compliance via real-time dashboards. Each action taken within the system is meticulously logged and traceable, providing inspectors and auditors with a transparent chain of accountability that extends from document approval through to the completion of training and the resolution of corrective actions. By ensuring such detailed oversight, QFacts significantly enhances the overall efficiency and reliability of quality management processes.
API Access
Has API
API Access
Has API
Screenshots View All
No images available
Integrations
GitHub
Jenkins
Jira
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
$17/month/user
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Enzyme
Founded
2016
Country
United States
Website
www.enzyme.com
Vendor Details
Company Name
QFacts
Founded
2024
Country
Belgium
Website
qfacts.be
Product Features
Quality Management
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
Product Features
Quality Management
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