Sparta Systems’ change control solution ensures all documented changes are properly managed and coordinated, globally. Change control management helps pharmaceutical companies increase transparency by managing change control procedures across all relevant departments or functions from initial request through pre-approvals, change execution, follow-up approvals, and implementation. All tasks and activities are tracked and managed including actions needed to complete the change, regulatory approvals, and updates. Furthermore, the change control solution for pharma and biotech links to other quality and regulatory processes such as corrective and preventive action (CAPA) and product registration tracking, effectively closing the EQMS (enterprise quality management software) loop.
The pharmaceutical change control solution enforces a standardized change control process across the enterprise while allowing the flexibility to accommodate specific workflow steps for a particular group or department. TrackWise by Sparta Systems is the only change management software designed to be flexible enough to manage all types of change using one centralized system. Change management applications include areas such as equipment, process, batch/materials, documents, computer systems, suppliers, emergency, labeling and packaging, EH&S changes, utilities, and validation.