Clinical GCP Auditing Solution
You realize you need greater control over and improved visibility into your quality and compliance processes. Your company’s Quality Assurance group is working hard to keep GCP audit programs organized with many different manual processes and spreadsheets. Your auditors are in need of a tool to drive a more efficient auditing process. Management is requesting a comprehensive snapshot of key audit program metrics. Whether your role is part of QA, QC, or Clinical Operations, principal investigator, sponsor, auditor or a stakeholder in the process, Sparta Systems' Clinical GCP Auditing Solution can help your organization streamline the GCP auditing process.
Sparta Systems' Clinical GCP Auditing Solution
The Sparta Systems' Clinical GCP Auditing Solution features the Audit Execution Package and provides a compliant method for auditors to draft audit reports offline while out in the field, while also providing organizational management the consistency in data needed to evaluate audit program effectiveness. In addition, since the solution includes the standard TrackWise software, customers receive the quality, compliance and workflow management capabilities inherent in to that software. For organizations looking to consolidate their auditing processes, S platform also has the ability to support all audit programs using an enterprise system.
A Fully-Integrated System
The need to measure and ensure quality is vital throughout all aspects of the clinical trial process. Leading enterprise quality management software (EQMS) solutions provide a flexible and configurable platform for tracking and managing quality and compliance events to ensure that clinical research activities are continually measured, monitored and improved upon. In addition to managing all aspects of the audit process, Clinical GCP Auditing Solutions manage the associated corrective and preventive actions (CAPAs), risk assessments, risk management and the analysis and approvals of changes such as protocol amendments. Sparta Systems’ quality management software solution also manages trial registration, documentation and protocols, study plans and reports, SOPs, and training records.
Key Features and Benefits of Sparta Systems' Clinical GCP Auditing Solution:
- Design flexible audit templates that simplify the process of auditing against regulations such as 21 CFR Part 11, Part 50, Part 54, Part 56, Part 312, and Part 812, ICH E2A, ICH E6(R1), and the EU Clinical Trials Directive
- Organize study records in an intuitive and hierarchical format such that they can be easily located while preparing for audits
- Maintain copies of clinical trial protocols within a seamless environment so they can be quickly and easily referenced
- Document findings and observations and draft audit reports in real time, on location, without online connectivity using the offline audit feature of the Audit Execution Package. This feature eliminates the time-consuming and redundant process of inputting notes into a word processor and then publishing to an electronic system
- Track and manage audit scheduling, audit plans, audit templates, audit execution, and the resulting follow-up activities, with all relevant parties working within one environment
- Generate reports to monitor and review auditor resource allocation and scheduling, draft and formal audit reports, and reports to track and trend on findings and corrective actions to drive continuous improvement