Critical or medical complaints trigger instant adverse event workflows, calculating MDR submission deadlines automatically.
Built-in investigation templates (5 Whys, Fishbone, Failure Mode Effects) assist engineers in determining root causes.
Track trending metrics by product, batch number, defect code, and customer location to identify failure patterns.
Directly spawn corrective or preventive actions within QMS from the root cause analysis stage of a complaint.
Explore the rich feature-set built to satisfy GxP validation requirements and maximize quality assurance.
Capture complainee details, product code, batch number, serial numbers, and defect descriptions. Attach photos, customer emails, or test logs.
Assess patient safety and compliance risks. Critical complaints are flagged immediately for adverse event reporting (MDR).
Track complaint return samples, log evaluation reports, and document lab analysis results in the master complaint record.
Document complete engineering investigations. Perform comparative analysis and link batch history documents.
Generate FDA 3500A (MDR) reports, adverse event notifications, or Vigilance reports, tracking submission dates.
Monitor post-market performance. Calculate defect ratios per batch and analyze monthly quality performance data.
Our software enforces a strict, step-by-step compliant process, guiding assets or audits from draft onboarding to final validation.
Log customer feedback, record product codes, check batch numbers, and tag complaint categories.
Determine severity (High, Medium, Low) and patient risk. Trigger MDR adverse event alerts for critical safety issues.
Issue return sample shipping labels, record receipt at testing labs, and upload physical testing results.
Quality engineers perform systematic root cause analysis, cross-referencing batch manufacture records and logs.
If a manufacturing defect is identified, spawn CAPA cards to revise manufacturing procedures or tooling calibrations.
Generate customer response letters detailing investigation findings and corrective actions, routing for approval.
File regulatory forms (like MDR), execute double-factor sign-off, and close the complaint record in the system.
This module operates independently but integrates natively with other QMS processes to ensure closed-loop compliance and automatic record updates.
Enforce strict complaint investigation steps linked directly to post-market surveillance and customer response SOPs.
Ensure only personnel with active training qualifications in complaint handling and MDR filing can modify records.
Seamlessly link complaints to open CAPA and Deviation workflows, tracking batch investigations through completion.
Reduce human error, save quality assurance overheads, and streamline regulatory compliance.
Triage severity and alert regulatory coordinators immediately, ensuring no serious adverse events go unreported.
Systematic root cause workflows and templates guide engineers to resolve complaints faster.
Enforce electronic signatures for triage assessments, root cause conclusions, customer letters, and closure logs.
Real-time dashboards identify batches or components with high defect rates, preventing future recall events.
Fully optimized to support critical environments with strict GxP, ISO, or GLP compliance requirements.
We combine cutting-edge software design with rigorous pharmaceutical validation methodologies.
Learn MoreEngineered following GAMP 5 principles to satisfy audits from FDA, EMA, and ISO registrars.
Pre-formatted fields map to regulatory reporting guidelines, speeding up post-market filing.
Every edit, sign-off, file download, or email sent is logged with date, user, and before/after details.
Secure databases with strict permission matrix control, preventing unauthorized access.