Fostering an Audit-Ready State for Quality and Compliance
Part of the goal of a regulated organization is a state of “audit readiness.” This means that when audited internally or externally by the FDA, the organization has the processes and documentation in place to pass any compliance audit. Verse's quality management system is built with traceability of events in mind; you can demonstrate GMP compliance in an audit from any adverse event and display a report of the root cause, action taken and verification of effectiveness. This is extremely important when reviewing your compliance processes with an auditor—the information is literally at your fingertips.
Simply put, Verse has the tools you need to make sure you comply with regulations and stay on top of reporting and recording adverse events.
Risk Management and Closed-Loop Corrective Actions
Beyond tracking and tracing compliance from beginning to end is fostering the ability to make systematic, objective decisions. Using the Verse risk management tools, you can filter adverse events by their risk, focusing first on the most critical events. This improves efficiency and productivity, and ensures that you're staying on top of high-risk events.
You can also close the loop with your corrective action by generating risk-based reports, to look for areas for improvement—thereby building a true closed loop on effecting change with your QMS system. Mitigates risks with CAPA
Meeting the needs of Validated Compliance
Part of the requirement of any quality and compliance solution is ensuring the software is validated to run the way it was intended. Verse solutions are validated and tested to ensure compliance, and any changes made to the solution can be validated with the Verse Validation package to ensure you are meeting regulatory requirements.
Compliance audit requirements include validation as a component, and with Verse, you are able to create a centralized, cloud-based, validated solution for FDA regulated industries.