Nonconformity management software for quality assurance. Allows to generate action plan (CAPA) requests that routes through register, review, plan, implement, and verification stages. It provides effective mechanisms to determinate the source and cost of problems.
A corrective action preventive action plan is essential to any company that is expected to meet all CAPA requirements as outlined in the 21 CFR 820.100 and 21 CFR 211.180 regulations and in ISO 8402. A corrective action plan is a strategy for correcting or eliminating a problem that has already occurred or been identified (as opposed to a preventive action plan which defines the steps taken to eliminate the root cause of a problem to prevent it from recurring ).
It is important to establish a corrective action preventive action plan throughout your organization because correcting and preventing SOP problems early will cost significantly less than fixing them later.
Lower risk of regulatory and standards non-compliance with FDA, ISO, GMP, GxP, EMEA, NERC, HACCP and others.
Easily setup and manage multiple, complex CAPA workflows using industry-standard best practices.
CAPA software drives workflow to greatly improve cycle times and reduce costs.
Capture real-time detailed data about issues and trends with powerful analytics tools while dashboards deliver live visibility into your entire CAPA process enterprise-wide.
The software identifies and links related issues across your operations and other quality management processes, reducing the occurrence and recurrence of incidents
Works seamlessly with your other quality processes such as audits, nonconformance, complaint handling, document management and change control to create a complete quality management system.