Change Control for Pharma & Biotech

Streamline Your Change Management Process

Sparta change control solutions ensure changes are properly documented and coordinated. Change control management helps pharma and biotech companies increase transparency by managing everything from initial request to 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. It also links to other quality and regulatory processes such as corrective and preventive action (CAPA) and product registration tracking.

Sparta change management solutions help enforce a standardized change control process across the enterprise while allowing the flexibility to accommodate specific workflow steps for a particular group or department. 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 Pharma and Biotech

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 your EDMS, ERP, and MES systems.
  • Increases accountability though assignments, process step sign-offs, and automated audit trails.

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