Field event logged from the distributor: device alarm failure during home use.
Complaint C-3312 · Product REN-40 · Lot 22-081
Solutions · Regulatory Affairs
The clock starts the moment the event lands.The evidence is still in five inboxes.
Reportability, submissions and label approvals close on deadlines someone else set. Unifize holds the decision and its evidence on one record, inside the clock.
Field event lands at intake
Runs wherever a regulator sets the deadline
If a regulator asks for it, it has a home here.
The work regulatory teams actually run, as governed workflows: named owners, evidence bound to the decision, a close that survives an inspection. Start with one, they link as you grow.
Submissions and registrations
Getting the product approved, and keeping it approved in every market you sell in.
- Product Registration and Market Authorization Maintenance
- Regulatory Variation and Submission Change Management
- Clinical and Pre-Market Evidence Management
Safety reporting
What the field tells you, classified and reported inside the clock.
- Adverse Event Reporting and Regulatory Notification
- Post-Market Surveillance and Vigilance Reporting
Labels, lots and borders
What is printed on the product, and what you can prove about the unit in the box.
- Label and Artwork Control
- Lot Traceability and Serialization Governance
- Cross-Border Regulatory Compliance
Rules, audits and site duties
The regulations move. The proof that you moved with them has to move too.
- Regulatory Intelligence and Impact Assessment
- Regulatory Change Management
- Audit Readiness and Response
- Environmental Health and Safety Compliance
- Waste Management and Controlled Destruction
The filing was true the day you sent it.
The failure modes we see inside regulatory teams. Each one is a document or a decision that moved after the record stopped watching.
- Submission cross-references chase outdated controlled documentsThe filing says rev 3. The register is already at rev 5.
- Field-action timeline rebuilt from email and meeting notesWhat you knew, and when, rebuilt from email.
- Labeling changes propagate inconsistently to packaging and insertsApproved once, landing on each endpoint weeks apart.
- Post-submission commitments fall between Regulatory and OperationsRegulatory tracks it. Operations runs it. Nobody closes it.
Every filing ages quietly. Finding the gap at inspection is the coordination tax.
Measure your coordination tax →Decide reportability where the evidence already is.
Most systems file the report. Unifize holds the reportability decision itself, so the classification, the causality view and who agreed seal into a trace the authority can replay.
Filings and field events, on one record.
Complaints, audits and corrective actions run in the Quality Management System; the controlled documents a filing cites, and the changes that move them, run in the Document Management System. One record under both.
- Explore the product →
Quality Management System
The event side of regulatory work: what the field reports, what the auditor finds, and what you committed to do about it.
- Explore the product →
Document Management System
The controlled record a filing cites: what a submission points at, what a change touches, and who has to be retrained when it moves.
Your systems stay. The case runs between them.
Keep the systems your filings already cite. Unifize runs the decisions around them, inside the clock, 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 named medical-device teams running the document, change and complaint work this page rests on.
- 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
Harmonic BionicsClarissa ArcherDesign history file linked, not printed into binders
Harmonic BionicsDenis MachokaDHF and DMR changes keep who, what and when for audits
Harmonic BionicsClarissa ArcherDesign inputs and outputs traced back to user needs
Harmonic BionicsMichael Hogan, Mechanical EngineerRisk file and design requirements, one engineering record
ApplechemWilson LinRegulatory documents for raw material validation, one place
Erica BennermanNutritional SupplementsWrong artwork revision from the printer flagged before print
ApplechemWilson LinIdeation to pre-commercialization about 30% faster
When the regulator sets the deadline.
Each of these starts a clock you do not control. Each routes into a governed workflow, so the response is coordinated on the record it will be judged by.
MDR or vigilance reporting deadline
Routes to Complaint Handling · owned by Vigilance · Regulatory Affairs
FDA Warning Letter received
Routes to Audit Management · CAPA · owned by Regulatory Affairs · Executive team
Design history file gap at audit
Routes to Document Control · Audit Management · owned by Regulatory Affairs · Engineering
Meet the deadline. Keep the reasoning.
Bring one workstream, a vigilance queue, a label approval backlog or an inspection response, and see the decision trace on your own work in a 30-minute walkthrough.