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Average Ratings 0 Ratings
Description
Ensuring uniform product quality and robust quality management procedures poses significant challenges in the current landscape of pharmaceutical manufacturing. Industries governed by strict regulations, including Pharmaceuticals, Biotechnology, and Life Sciences, must adhere to Good Manufacturing Practices (GMP) to comply with legal standards. Beyond merely fulfilling GMP obligations, it is essential to provide evidence of compliance. Relying on paper forms, isolated systems, or manual procedures to oversee, monitor, and document quality issues and responses fails to offer effective solutions for establishing cohesive and integrated quality management practices that align with industry standards. Consequently, organizations must seek more advanced and automated systems to enhance their quality assurance efforts and streamline compliance.
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
No details available.
Integrations
No details available.
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
Novatek International
Founded
1996
Country
Canada
Website
ntint.com/product/nova-qms/
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