| Medical Device Industry |
| SERCORO, INC. |
SERCORO Inc. provides professional services of development and
implementation for the following requirements of FDA Quality Systems
Regulation (QSR) and Current Good Manufacturing Practices (CGMP):
implementation for the following requirements of FDA Quality Systems
Regulation (QSR) and Current Good Manufacturing Practices (CGMP):
- Company’s Quality Management System (QMS)
- Corrective & Preventive Actions (CAPA)
- Investigation & Effectiveness Check
- Statistical Process & Quality Control (SPC/SQC)
- Product and Process Design Control Plans
- Design History Files (DHF) for new products
- Device Master Record (DMR) & Device History Record (DHR)
- Manufacturing and Product Quality Plan (MPQP) for new process
- Design/Process Failure Mode & Effects Analysis (DFMEA/PFMEA)
- Equipment Installation and Operation Qualification Protocols
- Process Characterization Studies & Performance Qualification
- Process and Software Validation & Optimization Protocols
- Manufacturing and Quality Process Flows Diagrams
- Manufacturing Line Layouts, Value Stream Maps & Routers
- Standard Operating Procedures (SOPs) & Work Instructions (WIs)
- Vendor Identification, Qualification and Validation
- Vendor & Customer Internal Audits
- Training for Current Good Manufacturing Practices (CGMP)
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