Audit starts Monday.
Evidence assembly starts now.
Audit schedules, checklists, findings, and evidence - all in one place, always ready.
Audit schedules, checklists, findings, and evidence - all in one place, always ready.
The problem
Internal audits happen ad hoc or not at all - no systematic coverage of QMS processes
Evidence lives in email, shared drives, and filing cabinets - assembled under pressure
Audit findings captured in Word documents with no systematic follow-up or closure
Same issues found in successive audits because corrective actions were never verified
The solution
Annual audit program covering all QMS processes with automatic scheduling and reminders
Configurable audit checklists mapped to ISO 13485 clauses and FDA requirements
Findings classified by severity, linked to CAPAs, tracked to closure with evidence
Evidence linked directly from QMS records - documents, training, CAPAs, changes
Connects to your entire QMS - evidence is collected from your live quality records, not assembled after the fact
Define scope, schedule, and auditor assignments for the year
Auditors work through structured checklists, recording observations and evidence
Classify findings, assign owners, link to CAPAs for systematic resolution
Monitor finding resolution, verify effectiveness, generate audit reports
To pull evidence for any process
QMS process coverage
Findings without CAPA linkage
Inspection-ready
Needs a systematic internal audit program that satisfies ISO 13485 clause 8.2.4
Need structured checklists and a systematic way to record findings and evidence
Needs confidence the company is inspection-ready at any time
Systematic audit management with finding tracking and evidence collection - configured in 21 days.