eQMS

In the life sciences sector, managing deviations and non-conformances effectively is crucial for maintaining compliance and ensuring product quality. Deviations occur when operations deviate from approved procedures, while non-conformances involve products or materials not meeting quality standards. Addressing these issues promptly is essential to prevent compliance risks and ensure safety.

With Quality Forward's eQMS, teams can efficiently report, investigate, and resolve deviations and non-conformances within a unified system that enhances traceability and compliance. This system supports real-time event capture, allowing deviations or non-conformances to be logged directly from the shop floor or lab, eliminating delays and data gaps.

Key Capabilities

• Real-Time Event Capture: Log deviations or non-conformances from any site or device.
• Configurable Categorization: Customize forms to differentiate and classify events according to your processes.
• Root Cause Investigation & Action Management: Investigate incidents, assign corrective actions, and escalate based on severity or risk.
• Compliance-Driven Process Control: Align with FDA 21 CFR Part 211/820, ISO 13485, and global GxP requirements.

Key Benefits

• CAPA and Change Control Integration: Escalate issues to CAPAs and link to related change requests with ease.
• Standardized Investigation Workflows: Ensure consistency in documenting, reviewing, and resolving events.
• Compliance-Built Design: Supports FDA, EMA, ISO, and GxP documentation requirements.
• Visibility Across Sites and Products: Track deviation trends, root causes, and systemic risks in real time.
• Audit-Ready Records: Maintain complete traceability from initial report to final resolution.

The system is configurable and requires no coding, allowing adaptation of workflows and forms without IT support. It is cost-effective and scalable, suitable for single sites or global quality teams, and is trusted by life sciences QA teams for its regulatory expertise. Built on ServiceNow, it offers security, reliability, and scalability without complexity, supporting end-to-end compliance and validation for various regulatory standards.

How It Works

• Log the Event: Submit a deviation or non-conformance with necessary details and attachments.
• Classify and Triage: Assign categories, link to batches or materials, and route for investigation.
• Investigate and Assess Impact: Document root causes, affected lots, potential risks, and containment actions.
• Trigger CAPA if Needed: Escalate to corrective or preventive actions for systemic issues.
• Implement and Verify: Track resolution steps, assign owners, and ensure follow-up completion.
• Close with Full Documentation: Ensure all records are reviewed, approved, and audit-ready.