Audit Management

The Audit Management software streamlines audit activities, cutting down on effort and time required to ace audits with efficiency. It integrates seamlessly within a complete electronic Quality Management System (eQMS), encompassing all essential modules for the life sciences sector like training management, nonconformance management, CAPA management, supplier management, and document control.

This comprehensive solution by SimplerQMS incorporates document templates, facilitating the creation of supplier, regulatory, external, and internal audits. Key functionalities include the ability to craft audit plans, schedule audits, assign issue handlers, and link evidence of audit findings, with an option to escalate these issues into Corrective and Preventive Actions (CAPAs) when needed.

Prepare Audit Plans Efficiently

Users can design audit plans using provided templates, customizing them to meet specific requirements. Audit plans can be structured by inputting metadata, including details such as title, site, department, process, and the personnel involved in various capacities like authors, reviewers, and approvers.

Regulatory Compliance Assurance

The software guarantees regulatory compliance by offering document control, ensuring only updated versions are in use. It also logs all document changes, maintaining a comprehensive audit trail with time stamps. The centralized cloud-based system simplifies document retrieval during audits and allows for detailed search capabilities within the documents.

Manage Audit Findings Effectively

SimplerQMS facilitates efficient management and resolution of audit findings by allowing the creation of audit reports and linking all related documents for complete traceability. Designate workflow roles to oversee audit drafts and CAPA evaluations, and escalate issues swiftly into CAPAs, keeping progress visibility and automatic notifications for stakeholders.

Optimize Supplier Audit Activities

Manage supplier quality audits effortlessly, with options to plan, schedule, and track all activities. Add documentation of nonconformity evidence in various formats, configure notifications for upcoming audits or expiring certificates, and generate supplier audit reports as needed.

This approach enhances continuous improvement across organizations by analyzing audit results to avert repeated issues. The interlinked modules ensure a synergy between functions such as equipment and supplier management.