
The Microsoft Word version of this checklist is an editable form that can be used to support process reviews.
| Process Checklist | ||||
| Are all the bases covered? | Yes | No | Not Applicable | Comments |
| Has the extent of traceability been defined? | ||||
| Are all user needs traced to system requirements and vice versa? | ||||
| Have the concept of operation scenarios been traced to the system requirements and the validation plan? | ||||
| Have the user needs been traced to the system validation plan? | ||||
| Is a requirements management tool needed for the project? | ||||
| If a requirements tool is needed, has it been procured and configured for the project? | ||||
| Is the staff trained on the use of the tool? | ||||
| Is access to the requirements management tool available to all stakeholders and the development team? | ||||
| Have the system requirements been traced to the system verification plan? | ||||
| Have the system requirements been traced to the design? | ||||
| Has the design been traced to the verification plans? | ||||
| Has the design been traced to implementation artifacts [SW source code, HW documentation etc.]? | ||||
| Have the verification procedures been traced to the verification plan? | ||||
| Have the validation procedures been traced to the validation plan? | ||||
| Has all needed supporting project documentation been traced to? | ||||
| Has traceability been maintained during the operations & maintenance, changes & upgrades, and retirement & replacement? | ||||