Audit Software for FDA Regulated Companies

Take Your Audit Management to the Next Level

FDA regulated companies must be able to demonstrate compliance to the agency. Unfortunately, many organizations still manage audits by a paper-based system. Not only are paper-based systems time-consuming; they can also cause more errors, creating compliance and quality concerns.

Sparta audit management software allows manufacturers to take a best practices approach to compliance and risk management. It enables auditors to plan and execute compliance audits more efficiently by providing an integrated tracking system and a powerful workflow engine that automates all steps in the audit lifecycle, including scheduling, preparation, auditing, report approval, report issuance, response and corrective action (CAPA) tracking.  Reports can be generated as needed, thereby eliminating time consuming paper-based processes. Responses to external regulatory and consumer audits can also be managed ensuring audit findings are resolved in a timely fashion. 
An Effective Tool for Managing Any Type of Audit Including:
External Audits  |  Internal Audits  |  Third Party Audits

Key Benefits To Automating Your Audit System

  • Reduce risk by enforcing consistent and harmonized processes and procedures across the organization
  • Securely manage all information in a centralized, scalable and reliable system
  • Facilitate compliance with global government regulations and industry standards
  • Save time and ensure consistency by creating an audit plan template with as little or as much flexibility as standards and corporate policy dictate
  • Improve supply chain collaboration by enabling suppliers to respond electronically, in your company’s format, to audit observations

Audit Software with Extended Capabilties

TrackWise Audit Execution Package is an audit management software tool that bridges the gap between the needs of your management team and your auditors, providing management the consistent data needed to evaluate audit system effectiveness while providing auditors the flexibility and authoring tools they need to be successful in the field.  

See TrackWise Audit Management Software in Action

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