Complaints and OOS results handled to the letter.
Log complaints with reportability assessment and the right clock, and manage out-of-specification results with the averaging rule fixed before the answer is known.
Complaint and OOS handling in Cybroscape eQMS records complaints with a reportability assessment and starts the right reporting clock for device complaints, and manages out-of-specification results through defined investigation phases. The averaging rule for a result comes from the test method at intake, so a failing result cannot be averaged into specification.
Decisions made after the answer is known
OOS findings often come from decisions taken after a result is seen — retesting until a pass, or averaging a failing value with passing ones. The rules exist; the timing is the problem.
Rules fixed before the result
Each method's averaging rule is read when the result is recorded, so the reportable value follows the method rather than the preferred outcome. The OOS investigation then runs through its phases with QA sign-off.
Complaints with the right clock
Complaints are assessed for reportability. For device complaints, the reporting clock for the relevant regulation starts automatically and stays visible until the report is made.
What you get
What Complaints and OOS delivers
Complaints and OOS is part of the Cybroscape eQMS platform — an AI-native, agentic quality management system built for regulated Life Sciences. See how it fits with Document Control, Deviations and Investigations, CAPA Management.
- Complaint intake with reportability assessment
- Regulatory reporting clocks for devices
- OOS investigation phases
- Averaging rules read from the method, not chosen after the result
Common questions
Prefer to talk first? Chat with us on WhatsApp or book a call with an expert.
Is the device reporting built in?
Yes, through the device pack: EU MDR vigilance and FDA medical device reporting timelines are started from the complaint.
Related capabilities
All capabilitiesWrite, review, approve and make effective SOPs, work instructions and forms, with periodic review dates and revisions opened automatically by the change that requires them.
Learn more about Document ControlDeviations and InvestigationsCapture deviations at the point they happen, classify severity, run the investigation with structured root-cause tools, and close only when the evidence supports it.
Learn more about Deviations and InvestigationsCAPA ManagementPlan corrective and preventive actions from the investigation, assign owners and dates, check effectiveness, and let the CAPA raise the change and the SOP revision it needs.
Learn more about CAPA ManagementChange ControlAssess, approve and implement changes with a risk-based impact assessment. Approved changes state their validation impact and pass it to GxP Copilot.
Learn more about Change ControlTraining and QualificationRole-based training matrices, assignments triggered by document changes, and a qualification check that stops someone with lapsed training from signing for GMP work.
Learn more about Training and QualificationSupplier QualityQualify suppliers, hold quality agreements and certificates, schedule audits, track supplier performance and let suppliers respond through a portal.
Learn more about Supplier QualitySee complaints and oos on your own data.
Bring a recent deviation or change. We show you how it runs end to end, from intake to closure.
- We reply within one business day
- We walk through your own records
- You get a clear migration plan