Product/Service

TrackWise Audit Execution Package Software

Source: Sparta Systems, Inc.

Sample Tracking Software
As authorities strengthen their oversight of regulated industries and increase the frequency of inspections, companies must be prepared to not only meet strict internal operational compliance requirements but also ensure the quality of goods and services provided by an increasingly global network of suppliers.

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Brochure: TrackWise Enterprise Quality Management System

As authorities strengthen their oversight of regulated industries and increase the frequency of inspections, companies must be prepared to not only meet strict internal operational compliance requirements but also ensure the quality of goods and services provided by an increasingly global network of suppliers. Sparta Systems TrackWise enterprise quality management software offers these companies comprehensive functionality for ensuring compliance with diverse global regulations and industry standards.

The Audit Execution Package expands the audit capabilities of TrackWise beyond the core strengths of quality and workflow management by offering a new suite to help auditors document results in real time. The solution drives efficiency within the audit process by enabling auditors and/or audit process owners to design audit plan templates with as little or as much flexibility as standards and corporate policy dictates. TrackWise audit execution provides management the consistency in data needed to evaluate audit program effectiveness while providing auditors the flexibility and authoring tools needed to be successful in the field.

Additionally, implementing TrackWise for audit management processes not only enables the execution of audits, but also provides mature functionality for following up on all identified findings and action plans. Powerful user dashboards, reporting and automated business rules and escalation paths can be implemented in conjunction with all aspects of the audit management lifecycle.

Key features & benefits:

  • Ability to draft audit reports in real time, in the field, without having online connectivity
  • Delivers an innovative solution that is compliant with a wide variety of global regulation and industry standards
  • Audit information is presented to the user in a cohesive, intuitive format that balances the look and feel of a continuous document-like format, with the inclusion of dynamic navigation, structured data fields and a modern rich text authoring capability
  • Company-defined audit agendas that can be designed with as little or as much flexibility as standards and corporate policy dictates
  • Offers the ability to send audit findings electronically to suppliers and then upload responses into your system in your format for later tracking and trending
  • Reduce risk by enabling consistent and harmonized audit processes across the organization

TrackWise is an effective tool for managing any type of audit including:

  • cGMP/GLP/GCP
  • Business Conduct Standards
  • Clinical Support Audits
  • Compliance
  • Computer Related System Validation Audits
  • Contractor Compliance Assessment
  • Internal Quality Audits
  • Risk Assessments
  • Internal Controls
  • Contractor/Supplier/Vendor
  • Third Party (FDA, EMEA, and others)
  • Pre-Clinical Studies
  • Processes
  • Internal Facility Projects
  • Method Validation Audits
  • EH&S Audits

Click Here To Download:
Brochure: TrackWise Enterprise Quality Management System