GALEN
Keep regulated quality cases complete, traceable and ready for QA/RA decision.
One complete working system, combining automation, AI and your business rules, that runs a job from request to result. It does the repetitive work of several people, inside your systems, under your rules, without dropping a step.
Device/lot links, evidence requests, approvals and audit records consume specialist time.
A complaint, CAPA event, controlled-document or quality-record task is opened.
Medical device OEMs and regulated MedTech quality teams.
One job, five steps, start to finish.
Register the case and connect device, UDI/lot, risk and eQMS references.
PERFORMValidate required fields and evidence; identify missing traceability.
PERFORMRoute complaint/CAPA/document decisions to the authorised QA/RA owner.
COORDINATEPrepare controlled records, evidence indexes and approved follow-up tasks.
PERFORMTrack deadlines, signatures, training evidence and audit-trail completeness.
MANAGEControlled quality-case file with traceability, approval evidence and audit trail.
Reportability, patient-safety assessment, CAPA approval and QA/RA sign-off.
Reported to its manager every month.
Start with one job.
See the numbers before you commit.
We assess this job on your process, write its Job Card and prove it in a pilot beside your team.