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Stay Audit Ready, Always!
Audits are critical for ensuring quality, compliance, operational efficiency, and process consistency across an organization. Whether it is an internal process audit, supplier audit, compliance audit, or third-party assessment, managing them manually often leads to missed schedules, fragmented records, delayed follow-ups, and limited visibility into findings.
QualityPro’s Audit Management Software provides a centralized platform to plan, schedule, conduct, monitor, and close audits efficiently. The solution enables organizations to standardize audit execution, automate workflows, manage findings, generate non-conformances, and seamlessly connect audit outcomes with CAPA processes.
Equipped with advanced features and functionalities, QualityPro helps organizations remain inspection-ready while fostering a culture of continuous improvement. It supports compliance standards like ISO 9001, ISO 13485, GMP, FDA 21 CFR Part 11, and other internal compliance programs.
Plan Audits with Structure & Consistency
- Create audit categories, classes, and types to differentiate various audits.
- Define audit objectives, scope, criteria, frequencies, locations, and departments within structured audit plans.
- Build multiple requirement codes and map them with one or more checklists for a flexible audit approach.
- Associate one or more checklists with specific audit types to ensure consistent audit execution.
- Maintain audit plan revisions, approval workflows, electronic signatures, and sequential audit numbering series.
Schedule & Coordinate Audits Efficiently
- Schedule one-time or recurring audits using configurable audit frequencies and recurrence cycles.
- Use the audit scheduling dashboard to view, perform and manage upcoming audits from a centralized location.
- Schedule multiple audits simultaneously to reduce manual planning effort.
- Assign lead auditors, auditors, external auditors, and auditees to each audit activity, with automated validation to ensure auditors and auditees belong to different departments.
- Provide role-based visibility and automated notifications to auditors and auditees, helping them stay informed, prepared, and aligned before the audit begins.
Execute Audits Through Managed Workflow
- Enable auditors and auditees to launch the audit cockpit directly from the notification alert and perform audits using structured digital checklists tailored to specific audit requirements.
- Configure audit checklists to support compliance standards like ISO 9001, ISO 13485, GMP, FDA 21 CFR Part 11, and other internal compliance programs.
- Capture responses using pass/fail, yes/no, and score-based evaluation methods.
- Record observations, comments, findings, and auditor remarks directly against checklist items.
- Attach photographs and supporting evidence to strengthen audit documentation and traceability.
Seamless Connectivity with NC & CAPA Modules
- Raise non-conformances directly from audit findings and generate one or more NCs as per requirement.
- Track NCs all the way through to closure & create a structured foundation for continuous improvement initiatives.
- Classify audit findings based on severity and prioritize corrective actions accordingly.
- Schedule and manage follow-up audits to verify the effectiveness of corrective actions.
Gain Complete Visibility into Audit Performance
- Monitor planned, completed, upcoming, and overdue audits through dedicated dashboards.
- Track audit findings, non-conformances, and department-level audit activities from one location.
- Generate detailed audit reports containing responses, findings, weighted scores, and recommendations.
- Export printable PDF audit reports for reviews, inspections, and compliance activities.
- Maintain complete visibility into audit histories, approvals, revisions, and audit records.
- Route audit reports through configurable approval workflows before final release and closure.
Supplier & External Audit Management
- Conduct supplier qualification audits using the same structured audit framework.
- Maintain a list of approved suppliers and evaluate their performance through predefined KPIs.
- Score suppliers against predefined audit requirements and evaluation criteria.
- Qualify or disqualify suppliers based on audit outcomes and performance.
- Manage centralized and third-party audits within a unified audit management environment.
Benefits of the Quality Audit Software
- Simplifies the complete auditing process.
- Reduces audit preparation and execution time.
- Ensures timely audit closures.
- Ensures adherence to compliance regulations.
- Turns audits from a periodic compliance activity into a continuous risk-management process.
- Strengthens accountability.
- Prevents repeat findings.
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