Industry Solutions

Audit Management

Audits monitor critical processes, identify gaps, and stimulate companies to improve quality. An audit management system is a critical tool for the efficient management of workflow, tracking of observations and resulting corrective actions associated with company internal audits as well as with supplier audits and regulatory inspections.

Many companies have numerous auditing groups that perform dozens of types of audits. As a result, companies have a variety of systems in place, which are not integrated as part of the broader enterprise quality management and compliance management system. This results in additional costs and missed opportunities to improve quality as well as to reduce risk of regulatory compliance issues.

TrackWise Audit Management Solutions

TrackWise software enables companies to improve quality, reduce costs, and identify operational risks by facilitating the full lifecycle management of audits and helping to ensure that findings are resolved in a timely and effective manner. TrackWise enables your organization to take an enterprise approach to its audit management and support all audit programs using a best practices approach.

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

  • GMP/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
  • Site Audits
  • Pre-Clinical Studies
  • Processes
  • Internal Facility Projects
  • Method Validation Audits
  • EH&S Audits
  • And others...
 

TrackWise helps auditors to plan and execute 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 tracking.

Sparta's unique TrackWise Audit Manager™ standardizes audits and increases auditor efficiency by providing online questionnaires and templates, performing scoring, and empowering audit team members to download their assigned audits to document results and findings offline. Audit reports can be produced directly from the TrackWise system eliminating time consuming paper-based processes.

Integrated CAPA Management

TrackWise enables your organization to manage all related CAPAs as part of its global management system. CAPAs resulting from internal or external audits can be classified separately enabling segregation from CAPAs originating from other sources. As a result, each CAPA will follow a distinct workflow, providing flexibility as well as the ability to perform consolidated trending for internal quality management functions.

View more information on CAPA management.

Benefits

  • Improve efficiency of auditing programs worldwide by providing a streamlined and fully electronic approach to managing audit schedules, documenting findings, generating and distributing reports, and tracking and monitoring corrective actions.
  • Reduce IT costs and redundant efforts by eliminating duplicate audit systems.
  • Improve compliance with audit targets and commitments by ensuring commitments are met and observations are closed.
  • Facilitate visibility of significant business risks and non-compliance situations through integrated automatic trend detection and integrated reporting.
  • Improve the audit program based on risk evaluations and targets to ensure resources are aimed at areas that require the most attention.
  • Enable different auditing organizations to utilize audits performed globally to support local regulatory requirements and reduce redundant auditing efforts.
  • Ensure compliance with industry regulations, ISO standards, and others.
  • Obtain on-line access to audit templates, audit reports, and other evaluation criteria.
  • Reduce supplier nonconformance by ensuring better tracking of supplier corrective actions plans.
  • Eliminate the potential of lost information by electronically and securely managing all information in a centralized, scalable, and reliable system.
  • Improve efficiency by automating workflow and implementing fully electronic and parallel review and approval processes.