Digitize every quality process, deviations, CAPA, audits, change control and complaints, with built-in audit trails, e-signatures and dashboards that keep you permanently audit-ready.
Registers, spreadsheets and email approvals leave gaps exactly where auditors look.
Events logged in registers get lost, deadlines pass silently, and repeat problems go unnoticed.
Actions live in spreadsheets with no owners, reminders or effectiveness checks.
Evidence is scattered across binders and inboxes, every audit becomes a week of hunting.
Changes happen without impact assessment, approval or traceability.
Follow a quality event through the closed-loop CAPA workflow, every gate owned, signed and audit-trailed.
All the modules of a modern QMS, connected to each other and to your LIMS and DMS.
Closed-loop corrective and preventive actions with owners, due dates and effectiveness checks.
Structured logging, risk classification and investigation for every unplanned event.
Out-of-spec, trend and control results handled with phase-wise lab investigations.
Plan internal and external audits, track findings and link them straight to CAPAs.
Impact-assessed, approved and traceable changes to processes, methods and documents.
Customer complaints captured, investigated and answered with full history.
Risk registers and matrices that drive triage decisions across the QMS.
21 CFR Part 11 signatures on every approval, with a tamper-evident history.
Trends, ageing and closure KPIs, the state of quality at a glance.
See deviations, CAPA and audits run end to end on your own processes, in a live Fiscal Ox QMS demo.