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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
Tailored specifically for the life sciences sector, eCADinfo is an engineering data management system that adheres to 21 CFR Part 11 regulations, aimed at enhancing compliance, productivity, and efficiency while simultaneously lowering costs in environments governed by the FDA. This system is capable of storing engineering data across diverse formats, which encompass engineering drawings, equipment or system specification databases, links to supplier websites, spreadsheets with device parameter details, as well as procedures, manuals, and shop sketches. eCADinfo enables users to organize this information into a structured hierarchy that aligns seamlessly with their existing business workflows. With its intuitive graphical user interface, users can quickly access a wealth of information, facilitating easier system maintenance and control. Key features of the engineering data management system include version control, collaboration tools, change management capabilities, standardization processes, and a compliant Excel spreadsheet environment that meets 21 CFR Part 11 standards. By streamlining data organization and management, eCADinfo ultimately supports the operational goals of businesses within regulated industries.
API Access
Has API
API Access
Has API
Integrations
GitHub
Jenkins
Jira
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
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
CIMINFO Software
Founded
2017
Country
United States
Website
part11solutions.com/ecadinfo/
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
Data Management
Customer Data
Data Analysis
Data Capture
Data Integration
Data Migration
Data Quality Control
Data Security
Information Governance
Master Data Management
Match & Merge