| qms_version |
2.2.0 |
| sop_id |
CSC PR.012 |
| sop_version |
|
| template_id |
CSC F.030 |
| template_version |
2.0.1 |
| record_version |
|
| record_id |
AC-001 |
| title |
Acceptance Criteria |
|
|
| Template ID |
CSC F.026 |
| Template Version |
2.0.1 |
| QMS Version |
2.2.0 |
| SOP ID |
CSC PR.012 |
| SOP Version |
2.0.1 |
| Regulatory References |
|
This document lists the tasks to be finalised, completed and approves before the application can be released to the
host department for routine clinical use.
This document applies to {{device.name}} release {{device.version}}.
[TODO: append any other application tasks for the safe deployment of the application as agreed with the host department]
| No. |
Item |
Signed |
Date |
| 1 |
Clinical safety case report approved |
|
|
| 2 |
All verification tests passed or justified |
|
|
| 3 |
All validation tests passed or justified |
|
|
| 4 |
Application deployed |
|
|
| 5 |
Work instructions & Label provided |
|
|
| 6 |
Service Level Agreement signed by both parties |
|
|
| 7 |
Risk assessment provided |
|
|
| 8 |
Retrospective evaluation completed |
|
|
| 9 |
Prospective evaluation completed |
|
|
| 10 |
Audit cycle and frequency confirmed |
|
|
| 11 |
Post deployment surveillance plan confirmed |
|
|
| 12 |
Communication channels confirmed |
|
|
|
|
|
|