Almost all regulated companies undergo audit, using an enterprise grade audit management software will facilitate to automate all audit-related tasks, activities and dramatically reduce the time and effort involved in conducting audits. AURA is web-based QMS software that helps organizations to effectively monitor and manage their regulatory compliance activities. Our organization-specific quality management system enables you to streamline audit scheduling process, mitigate operational risks, optimize quality mgmt. process across the organization and assure compliance against various ISO / Regulatory standards.
A powerful & flexible QMS software for regulated companies
With Aura QMS Software, Organizations can seamlessly automate quality management processes & maintain quality standards specific to different business areas within the enterprise. Actually, Quality Management is not alone related to audit process efficiency, it is about continuously improving and leveraging the corrective action, preventive action data to make better, more informed decisions. Aura has set of features to streamline internal audit and thereby meet requirements of the ISO 9001, ISO 14001 and ISO 13485 standards.
- Reduces costs of correcting defects and enables companies to monitor risks and ensure compliance across organizational regulatory standards.
- Facilitates to avoid gaps in compliance, expose ineffective controls and help improvements in process requirements that lead to customer satisfaction and new improvement initiatives.
- Assists organization in managing meetings, trainings schedule, goals / POA tasks and complete internal audit activities.
How AURA Supports ISO 9001, ISO 27001, ISO 14001 & ISO 13485 Compliance
AURA is designed as an Audit, Document & Training Management System that helps organizations manage ISO compliance through audit scheduling, document control, training management, corrective action workflows, dashboards, and complete audit traceability.
| ISO Standard | Audit Planning | CAPA / Audit Closure | Document Management | Training Records | Audit Trail |
|---|---|---|---|---|---|
| ISO 9001 | Supports internal audit schedules and quality audit planning. | Supports nonconformity closure and corrective action management. | Supports document control for QMS procedures, SOPs, and quality records. | Supports competency management and employee training records. | Supports traceability of audit evidence and compliance history. |
| ISO 27001 | Supports ISMS audit planning and security control reviews. | Supports corrective action tracking for information security audit findings. | Supports management of security policies, procedures, and control documents. | Supports security awareness and employee training records. | Supports evidence trails for document changes, reviews, approvals, and audits. |
| ISO 14001 | Supports environmental audit planning and compliance assessments. | Supports closure of environmental nonconformities and improvement actions. | Supports EMS procedures, environmental policies, and compliance documentation. | Supports environmental awareness and role-based training records. | Supports traceability of environmental audits and compliance activities. |
| ISO 13485 | Supports medical device quality audit planning. | Supports CAPA management for quality and regulatory findings. | Supports controlled documents, SOPs, forms, and quality records. | Supports competency and training evidence for regulated personnel. | Supports audit-ready traceability for regulated quality processes. |
Note: AURA supports ISO compliance workflows, audit management, document control, training records, and evidence management. ISO certification depends on how each organization implements, maintains, and continually improves its management system and compliance processes.
Advantages of using Aura QMS Software
- Mitigate Risks Identified
- Complete Visibility of Audit Process
- Record Valuable Audit Insights
- Facilitates Audit Cycle
- Document / Data decentralization – Online document Management. Anybody who is in need of a document template / data, need not wait for anyone.
- Efficient Event / Schedule Management – Time spent for communicating the audit plans, reports & tracking the status can be reduced
- Automatic alerts – supports the users by reminding the schedules which results in 100% schedule adherence
- Outlook integration – Schedules would be integrated in the respective user’s outlook
- Schedule Notifications – Email triggering during AUDIT schedules, Pre Audit & Post Audit activities
- Effective task management supports from missing out tasks. Also facilitate to track the task completion trend.
