Change Planning, Initiation and Approval
MetricStream Change Management module allows users to initiate a change request (CR) with detailed information, such as area (e.g. process, equipment, or document) scope, rationale, type (e.g. normal or emergency), change date, associated risks, and expected impact, associated nonconformance or CAPA. Product manager can analyze internal processes that will be affected and identify customers who will be impacted.
Depending on the CR parameters, it is automatically routed for evaluation, review, and approval. The request can be routed to the quality units, management teams, and Change Request Board (CRB) in parallel for their assessment and approval. Any testing requirement or impact on regulatory requirements, training, lot disposition, validation, quality, or stability is documented.
A classification procedure can be defined to determine the level of testing, validation, and documentation needed to justify changes to a validated process. If needed, CR can be routed to technical/scientific experts for review and approval.
Change Execution and Tracking
The system ensures responsiveness as the CR appears on the task list of the assigned person upon approval with a due date and failure to act by due date leads to escalation. The change may be broken into smaller units of activities and tasks and assigned to different individuals or teams. The system shows the current status of the CR for real-time visibility and tracking as it goes through various stages of its lifecycle.
Change Verification and Closure
The module enables a closed loop change management by assigning verification tasks to evaluate the outcome of the change on affected products or processes. Early samples from the changed process can be flagged for stability and quality monitoring. Post change assessment is routed for approval by quality management units for final closure and if the change is determined to have regulatory impact, Regulatory Affairs personnel are notified.
Reports and Metrics
The solution provides complete visibility into the change requests database and lifecycle with comprehensive aggregate reporting as well as individual request status tracking. The user gains an ability to associate various types of changes for identifying trends or common categories for change requests. Graphical executive dashboards provide statistics and data by a variety of parameters like change types, status, average closure times, plants, region, etc. with drill-down capability.
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