Complaint logged from the pharmacy chain: cap seal breach on Lot 22-303.
Complaint C-4471 · Product VYN-12 · Lot 22-303
Solutions · Post-Market & Recall
A recall is four workflows at once.Each one runs its own clock.
Manufacturing hold, customer notification, returns logistics and the regulatory submission move in parallel, under different owners. The decisions that hold them together happen on calls nobody records.
Complaint intake, product and lot referenced
Runs wherever product is already in customers' hands
Everything that happens after the product ships.
The work post-market teams run, as governed workflows: named owners, evidence bound to the decision that used it, a close an authority can review. Start with one; they link as you grow.
Complaints and the signal underneath
What customers report, and what the pattern across reports is telling you.
- Customer Complaint Investigation and Resolution
- Complaint and Event Trending and Signal Detection
- Customer Feedback and Voice of Customer Governance
Reportability and the authority's clock
Deciding what has to be reported, to whom, and filing it before the clock runs out.
- Adverse Event Reporting and Regulatory Notification
- Post-Market Surveillance and Vigilance Reporting
Field action, start to close
Getting product corrected or back, and proving to the regulator that it worked.
- Field Safety Corrective Action and Recall Execution
- Field Action Effectiveness Monitoring and Close-Out
- Product Returns and RMA Processing
- Warranty Claims Management
The installed base
Product already in the field: serviced, supplied and eventually retired.
- Field Service and Maintenance
- Installation Qualification and Field Commissioning
- Service Parts and Replacement Supply Chain
- Installed Base and Product Discontinuation Management
- End-of-Life and Product Discontinuation Notification
The action gets executed. The chain can't be shown.
The failure modes we see in post-market teams. None of them is a missing feature. All of them are decisions and evidence that sat outside the record when the clock started.
- Recall traceability assembled in spreadsheets under regulator pressureWhich lot went where, rebuilt from exports under the clock.
- Complaint trend signals lost in case-by-case triageEach complaint triaged alone. The cluster stays invisible.
- Field service feedback never reaches the design loopThe technician knows how it fails. Engineering never hears.
Traceability, rebuilt under the clock. That rebuild is the coordination tax.
Measure your coordination tax →Run the field action where the four clocks meet.
Most systems file the complaint, the report and the recall in three different places. Unifize keeps one thread from intake through reportability into the field action, so the hold, the notification, the returns and the submission move against the same record.
Complaint to lot, on one record.
Complaints and the corrective actions they raise run in the Quality Management System; lot records and the genealogy a recall depends on run in the Manufacturing Execution System. One record under both.
- Explore the product →
Quality Management System
The complaint backbone: intake, reportability assessment, investigation and the corrective action it raises, on one governed record.
- Explore the product →
Manufacturing Execution System
The traceability leg: which lot, which inputs, which shipment, answered from the record instead of a spreadsheet rebuild.
Your systems stay. The recall runs between them.
The complaint file, the shipment records and the lot genealogy stay where they are. Unifize runs the field action between them, and the approved outcome goes back with a 21 CFR Part 11 signature. No rip-and-replace, no revalidation.
Proof, to the standard you'd hold us to.
A signed baseline, not a brochure stat, plus the named teams already running complaint work on Unifize.
- Customer-attested · medical devices41%lower non-conformance coordination cost, measured in year oneMedical-device manufacturer$81,350 a year recovered against a signed $198,150 baselineSigned baseline, anonymized
Biovation LabsJesse Kolstad, Director of QualityMock recall done in 18 minutes against a 4-hour window
Biovation LabsJesse Kolstad, Director of QualityOne lot number gets a complaint investigation 70% done
Erica BennermanNutritional SupplementsComplaints logged in 10 minutes or less, trended by product
The Will-Burt CompanyTedd Carr, Director of Quality ControlCustomer complaints closed in 11.4 days, down 60%
Harmonic BionicsClarissa ArcherComplaints connected to the design inputs and outputs
Harmonic BionicsDenis MachokaMaterial consumed per robot traced by lot, issues flagged
Jarod MarkleyMedical DevicesReturned-device RMA data opens the complaint, no re-keying
When the field becomes the headline.
Each of these starts a clock the authority is counting, and each routes into a governed workflow, so the response is coordinated on the record it will be judged by.
Recall scope definition required
Routes to Complaint Handling · Field action · owned by VP Quality · Chief Medical Officer
MDR or vigilance reporting deadline
Routes to Complaint Handling · owned by Vigilance · Regulatory Affairs
Production hold pending disposition
Routes to Non-conformance · owned by Plant Manager · QA
Four clocks. One thread.
Bring a live complaint backlog or your last field action, and see the hold, the notification, the returns and the submission on one record in a 30-minute walkthrough.