GLP and GCP Auditing: Utilizing TrackWise Beyond the World of GMP

Are you a GLP or GCP auditor?  Is working with your auditing tools the worst part of your day?  Auditors and Quality Assurance groups are plagued with redundant paper systems, unorganized manual processes, endless spreadsheets – an inefficient, time-consuming burden.  TrackWise offers a sophisticated auditing system that can automate and streamline the GLP and GCP auditing processes. For years TrackWise has been successfully utilized for GMP auditing in manufacturing environments, producing measurable results including increased productivity and efficiency, lowered costs, reduced risk, and increased ROI.  Yet since TrackWise software is designed to be widely applicable it can be leveraged across a broad range of functions within the various regulated industries.  Sparta Systems understands the needs of preclinical and clinical quality groups, including GLP and GCP auditors, and is pleased to share best practices to address preclinical and clinical quality, compliance, and auditing requirements.

The TrackWise Preclinical GLP Auditing Solution allows auditors to generate audits from the master schedule, while providing the QA Unit the ability to maintain the master schedule in a separate, GLP-compliant format.  The TrackWise Clinical GCP Auditing Solution provides a hierarchical structure starting with the clinical program and its related studies down to the associated audits, findings, and CAPAs.

Both solutions leverage the capabilities of the TrackWise Audit Execution Package, which allows you to design flexible audit templates that simplify the process of auditing against regulations.  The offline audit feature of the Audit Execution Package enables you to document findings and observations and draft audit reports in real time, on location, without online connectivity, and then upload work done offline back into the TrackWise online system.  This feature eliminates the time-consuming and redundant process of inputting notes into a word processor and then publishing to an electronic system.

In scenarios where there is a drive towards centralization, a global auditing system can eliminate departmental auditing point solutions.  As an enterprise system, TrackWise provides for the opportunity to harmonize all auditing processes with one standardized, holistic system, while allowing for different auditing groups to maintain separate workflows, templates, and record structure.  Enterprise audit systems provide executive management complete transparency and visibility through powerful reporting on trending and metrics.

GLP and GCP auditing does not have to be an inefficient, time-consuming process.  Advanced, automated systems can simplify the auditing process…maybe it will even be the best part of your day?

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