Challenges
Eroding margins
Expiring patents
Global competition
Heavily regulated, requiring complete traceability
Rigorous quality control required - High risk/consequence of error
Too much data on paper, need to create useful information

QIC Solution
Web-based and accessed by a standard browser
A completely paperless system meeting CGP requirements
Electronic signatures per FDA 21CFR Part11
Configured for compliancy to ISO13485 and 21CFR Part 820
Validation support including IQ, OQ, & PQ
Audit support (customer, internal, external)
CAPA (Corrective & Preventive Action) support
Customer Complaint Management
Document Management
Risk Management & Change Management support
Quality control & management
Supplier Management
Regulatory submissions
Electronic workflow
Integration with Microsoft Office®
MES (Manufacturing Execution Systems)
Employee Training Management
KPI (Key Performance Indicators) reporting
LIMS (Laboratory Information Management System)
Traceability & Lifecycle Management

QIC: Helping you achieve more.