Change Control

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.

Change Control Management in the Pharmaceutical Industry

When implemented and managed successfully, an automated change control management solution improves a drug’s cycle time and time to market, supports global supply chain initiatives, enhances product quality and the flexibility to adapt to changing drug regulations and, in turn, reduces operational cost. Managing all change control processes in a centralized and harmonized way enables pharmaceutical companies to eliminate redundant systems, decrease production costs, and reduce corporate liability and patient risk.

Benefits of Sparta Systems' Change Control Solution:

  • Ensures compliance with industry and government regulations and standards for pharmaceutical and biotechnology focused organizations
  • Enables proper coordination across stakeholders through automated workflows and alerts
  • Decreases cycle time and production/operation costs by enforcing consistent and harmonized change management processes across the entire organization
  • Provides seamless integration with EQMS functionality such as CAPAs, and other quality activities
  • Reduces risk of lost or incomplete data through an automated closed-loop change control process
  • Increases operational transparency through automated alerts, summary views using dashboard functionality, and extensive reporting capabilities
  • Reduces costs of change control driven by multiple redundant, siloed systems
  • Improves other pharmaceutical and biotechnology quality and operating processes by integrating with other enterprise-level control systems such as EDMSs, ERPs, and MESs
  • Increases accountability though assignments, process step sign-offs, and automated audit trails

Three Best Practices for Global Change Control

Change Control Guide for Pharmaceutical Companies

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