Streamline Complaints Management by capturing, investigating, and resolving product complaints with speed, consistency, and full compliance. Keep patients safe, regulators confident, and your quality system airtight.
Streamline Complaints Management by capturing, investigating, and resolving product complaints with speed, consistency, and full compliance. Keep patients safe, regulators confident, and your quality system airtight.
In the life sciences industry, product complaints are serious business. Every issue – from device malfunctions to adverse drug events, must be recorded, assessed, and resolved in accordance with strict regulatory requirements.
Quality Forward’s eQMS gives you a centralized system for managing the full complaint lifecycle. From intake to investigation to resolution, everything is tracked, traceable, and ready for inspection.
Automatically triage complaints based on severity, product category, or geography.
Link each complaint to relevant CAPAs, deviations, or change controls for full traceability.
Ensure alignment with FDA 21 CFR Part 820/211, ISO 13485, EU MDR, and other global standards.
Capture complaints from any source - field reps, patients, or distributors - with simple forms
Route complaints for triage, investigation, and QA review automatically
Link complaints directly to investigations and follow-up actions
Capture everything in one place - responses, records, approvals, and timelines
Meet FDA, ISO, and EU regulatory requirements with built-in controls
Ensure timely resolutions and continuous improvement across your product lines
Easily customize forms, workflows, and escalation paths – no IT needed
Built for startups, scaling biotechs, and global manufacturers alike
Designed for pharma, biotech, and medical device teams navigating FDA, EMA, and ISO audits
Automatically detect high-risk areas and recurring incident patterns
Enterprise-grade infrastructure for speed, security, and stability
Maintain full traceability and validation for 21 CFR Part 11, 820, ISO 13485, and EU MDR
Use structured intake forms to collect all required complaint details up front
Assign based on product, severity, market, or regulatory requirements
Document findings, root cause, and related product records
Open CAPAs directly from the complaint record to ensure timely follow-up
Spot recurring issues by product, region, or supplier with built-in analytics
