LCMSBusinessSolutions |
Business Overview/1 |
|
|
| Company General |
|
|
| History/Background |
|
|
| Organization: |
Management/Departmental Interfaces |
|
| Facility: |
Suitability for purpose |
|
|
Compliances |
|
| Functional Areas |
|
|
| Marketing |
|
|
| Research and Development |
Idea Assessment/Portfolio Review/Hurdles |
|
|
Design Process |
|
|
Design Reviews |
|
|
Design History File Maintenance |
|
|
Management reporting |
|
|
|
|
| Trademarks and IP: |
Freedom to operate |
|
|
Protection |
|
|
|
|
| Manufacturing and Operations: |
Design Transfer/Sustaining Engineering |
|
|
Pilot Production/Manufacturing Engineering |
|
|
Sourcing/Procurement |
|
|
Assembly |
|
|
Test/Burn In - Release Criteria |
|
|
Packaging |
|
|
Shipping |
|
| Manufacturing General: |
volume commitment requirements |
|
|
last time buy approaches |
|
|
DFM issues |
|
|
CAPA |
|
|
Engineering Change (ECR) |
|
|
|
|
| Regulatory: |
GMP |
|
|
|
|