A Complete Clinical GCP Auditing Solution
You need greater control and 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 can help.
Compliant Offline Audit Features
Sparta provides a solution that allows auditors to draft reports offline out in the field. Reports can be templated to provide the consistency needed to evaluate audit program effectiveness. Audits can be linked to other quality management and regulatory compliance processes. This helps companies to consolidate redudant systems and eliminate manual processes.
A Fully-Integrated System
The need to measure and ensure quality is vital throughout all aspects of the clinical trial process. Sparta quality management system (QMS) software provides flexible and configurable platforms for tracking and managing quality and compliance events. They help ensure that clinical research activities are continually measured, monitored and improved upon. Your audits can be linked to CAPAs, risk assessments, risk management and the analysis and approvals of changes such as protocol amendments. And, other quality processes like trial registration, documentation and protocols, study plans and reports, SOPs, and training records.
Features and Benefits of Sparta's Clinical GCP Auditing Solution
- 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.
- Organizes study records in an intuitive and hierarchical format such that they can be easily located while preparing for audits.
- Maintains copies of clinical trial protocols within a seamless environment so they can be quickly and easily referenced.
- Documents findings and observations and drafts audit reports in real-time, on location, without online connectivity using the offline audit feature.
- Tracks and manages audit scheduling, audit plans, audit templates, audit execution, and the resulting follow-up activities, with all relevant parties working within one environment.
- Generates 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.
- Securely manages all information in a centralized, scalable and reliable system.
- Increases productivity and efficiency and reduces non-value add activity and the potential for errors by eliminating the process of duplicating data entry.
- Reduces risk by enforcing consistent and harmonized processes and procedures across the organization while allowing auditors the appropriate level of flexibility to do their job.
- Increases accountability and collaboration by assigning activities to responsible parties and monitoring due dates through interactive dashboards.
- Lowers costs by consolidating redundant systems and enhancing collaboration, fueling cost-savings, and increasing ROI.