Capture and resolve deviations and non-conformances early to prevent compliance risks, protect safety, and keep your product audit-ready.
Capture and resolve deviations and non-conformances early to prevent compliance risks, protect safety, and keep your product audit-ready.
In the life sciences industry, deviations and nonconformances are inevitable – but how you handle them defines your compliance posture. Deviations typically occur when operations drift from approved procedures, while nonconformances relate to products or materials that fail to meet quality requirements.
With Quality Forward’s eQMS, your teams can report, investigate, and resolve both types of events in a single, connected system that supports traceability and compliance.
Log deviations or nonconformances directly from the shop floor or lab. no delays, no data gaps.
Differentiate and classify events using customizable forms tailored to your processes.
Investigate incidents, assign corrective actions, and escalate based on severity or risk.
Ensure alignment with FDA 21 CFR Part 211/820, ISO 13485, and global GxP requirements.
Log deviations or nonconforming material reports (NCMRs) from any site or device
Escalate issues to CAPAs and link to related change requests in one click
Ensure consistency in how events are documented, reviewed, and resolved
Built to support FDA, EMA, ISO, and GxP documentation requirements
Track deviation trends, root causes, and systemic risks in real time
Ensure complete traceability from initial report to final resolution
Adapt workflows, forms, and approval steps without any coding or IT support
Support a single site or global quality teams with consistent tools and controls
Built for pharma, biotech, and medical devices with deep regulatory expertise
Identify repeat offenders, trend root causes, and reduce deviation recurrence
Get the security, reliability, and scalability you need – without the complexity
Support for 21 CFR Part 11, GxP, ISO 13485, Annex 11, and full validation documentation
Submit a deviation or nonconformance with required fields, severity, and attachments
Assign categories (e.g. critical, major, minor), link to batch or material, and route for investigation
Document root cause, affected lots, potential risks, and containment actions
Escalate to corrective or preventive actions when systemic issues are identified
Track resolution steps, assign owners, and ensure follow-up is complete
Ensure all records are reviewed, approved, and audit-ready
In life sciences, managing safety incidents isn’t optional – it’s essential. Whether it’s a near-miss in a cleanroom, an injury on the manufacturing floor, or a lab equipment hazard, every event must be documented, investigated, and resolved in a timely, compliant way.
