Traceability and audit readiness transform the Hundredjack mouthguard from a handcrafted object into a certified medical-adjacent product.
Every step, material, and technician must be documented to ensure safety, accountability, and legal compliance.
Guarantee full traceability of materials, machines, and technicians.
Enforce safety and hygiene standards throughout production.
Provide evidence for audits and regulatory inspections.
Lab Technicians: Record all production steps, materials, and machine IDs.
QC Officer: Approve digital checklist and generate Certificate of Conformity.
Hundredjack Operations: Conduct audits, monitor SaaS records, enforce compliance.
Record batch numbers for all sheets, foils, and resins used.
Expired or untraceable materials = automatic rejection.
All logs must be stored in SaaS and linked to case file.
Record thermoformer ID, 3D printer ID, and calibration logs.
Machine calibration must be up-to-date and stored in SaaS.
Out-of-calibration machines must not be used.
Assign responsible technician ID in SaaS.
Each step (model prep, pressing, finishing, QC) must be timestamped and digitally signed.
Complete QC checklist in SaaS.
QC Officer must sign off digitally before packaging.
SaaS generates Certificate of Conformity which must:
Be enclosed in packaging.
Be archived digitally with case file.
PPE (gloves, mask, eye protection) mandatory during all handling.
All impressions/models disinfected before processing.
Work areas disinfected before and after each shift.
Waste (offcuts, foils, failed prints) disposed of as biomedical waste, in line with local regulations.
SaaS records: completeness of case file (materials, technicians, QC, shipping).
Machine logs: calibration and maintenance records.
Packaging: branded components, tamper seals, certificates included.
QC documentation: digital signatures, rejection logs, corrective actions.
Scheduled audits: Twice annually for each lab.
Random spot audits: Performed at Hundredjack’s discretion.
Missing/incomplete SaaS records = non-conformity.
Critical breaches (uncertified material, uncalibrated machine, missing QC) = immediate suspension.
Repeated violations = permanent removal from Hundredjack Labs network.
At the end of this stage:
Every Hundredjack mouthguard is fully documented, fully traceable, and legally defensible.
Lab is audit-ready and compliant with Hundredjack’s global standards.
If it is not logged in SaaS, it did not happen.
Certificate of Conformity is mandatory — no exceptions.
Safety violations = escalation to Hundredjack Operations immediately.