|
Medical Device Manufacturing Systems |
|
Intrasect Technologies’ experience ranges from helping R&D track and analyze process variables on new designed, increase manufacturing efficiency through increased quality and reduced downtime, monitoring clean room environments, and creating electronic device history records. Research & Development
Production - ERP Integration
- Product Genealogy
- Process Control
- Work Order Queue Visualization
Clean Room & Product Labeling - Passivation & Sterilization Control & Monitoring
- Clean Room Monitoring & Reporting
- Incoming Work Order Queue
- Product Labeling & Verification
Regulatory Compliance - Electronic Device History Records
- Electronic CAPA
Facilities
- Asset & Inventory Management
- FDA Compliance
FDA Compliance
- Intrasect’s systems and applications are compliant with 21 CFR Part 11, 21 CFR Part 210 & 211, 21 CFR Part 820 & ISO 13485
Scalability - Intrasect can help individual plants and departments drive lean initiatives while having capabilities to aggregate data from multiple plants, enabling management to implement continuous improvement globally across divisions.
|
 - Web Large.jpg "ESET"){kind=small}