Ensures full traceability
Changes can come as new requirements, enhancements, bug fixes and can be traced to (Incidents), and Deviation (CAPA). The Change Request also links to the impacted Documentation, Solution and Testing for full traceability. The Change Management module workflow within MyBlueLabel are as follows: Change Request Realization status New, Started, In Review, In Review QA, In Approval, Completed.
Root cause analysis
Change Request can have an impact on the originally planned scope, time-line and budget. Therefore it is important that Change Request is approved by the correct stakeholders such as System Owner and Quality Management.
Change Requests can be linked to the other modules to ensure end-to-end traceability between Change Requests and other Critical-to-Quality activities.
Having the constant update of Change Request will optimize the project flow as it provides a transparent, communicated and approved impact on original project scope. In addition it will give a realistic estimation of expected time of delivery of agreed deliverables and impact to project Go-Live.
Modules in MyBlueLabel QMS Software
MyBlueLabel has a suite of modules to support the full ecosystem of processes to comply with regulations and international standards. The modules are integrated or can work as standalone modules.