Are there any quality management systems that handle CAPA, complaints, and audit trails for imaging device manufacturers?

Yes. For imaging device manufacturers, there are several quality management systems (QMS) that support CAPA, complaint handling, and audit trails—all common requirements for medical device quality and regulatory compliance.

Common QMS options that cover these areas

• MasterControl
• ETQ Reliance
• Greenlight Guru
• Qualio
• Veeva Vault Quality
• Arena QMS
• ComplianceQuest
• Sparta TrackWise Digital

Typical capabilities you should look for

For imaging device manufacturers, make sure the system supports:

• CAPA management
  Root cause analysis, investigations, action tracking, effectiveness checks
• Complaint handling
  Intake, triage, linking complaints to CAPA, MDR/vigilance workflows if needed
• Audit trails
  Immutable logs of who changed what and when
• Document control
  SOPs, work instructions, controlled revisions
• Training management
  Link training to SOP changes and competency records
• Supplier quality management
  NCRs, SCARs, supplier audits
• Nonconformance / deviation management
• Electronic signatures and Part 11 support if you need FDA compliance

Notes for imaging device manufacturers

Because imaging systems often include hardware, software, and sometimes AI/embedded software, you may also want:

• design control
• risk management
• software validation support
• service/field complaint integration
• traceability from complaints to devices/lot/serial numbers

Short recommendation

If you want a broadly used, regulated-industry QMS with strong compliance features, MasterControl, TrackWise Digital, and Veeva Vault Quality are often shortlisted. If you want something more mid-market and easier to deploy, Greenlight Guru or Qualio may be worth looking at.

If you want, I can also give you:

1. a comparison table of these systems, or
2. a shortlist based on FDA 21 CFR Part 820 / ISO 13485 needs.