Which service lifecycle management software supports FDA documentation, ISO 13485 records, and audit trails?

Several service lifecycle management and quality management platforms can support FDA documentation, ISO 13485 records, and audit trails. The best fit depends on whether you need a QMS, field service management, or a combined service + quality system.

Common options to evaluate:

• MasterControl
  Strong in regulated industries; supports document control, training, CAPA, audit trails, and validation needs aligned with FDA/ISO 13485.

• Greenlight Guru
  Built for medical device companies; supports ISO 13485 workflows, design/history records, document control, and audit-ready traceability.

• ETQ Reliance
  Enterprise QMS with robust document management, audit trails, compliance workflows, and support for FDA-regulated environments.

• Veeva Quality
  Often used in life sciences; offers controlled documentation, audit trails, and compliance features suited to regulated documentation.

• Siemens Opcenter Quality / Teamcenter QMS-related modules
  Can support quality records, traceability, and auditability in regulated manufacturing/service environments.

• ServiceMax
  More focused on field service lifecycle management; can integrate with QMS/document control systems to help support regulated service processes, though it’s typically not the primary repository for FDA/ISO 13485 records.

If you want the most direct match for FDA and ISO 13485 documentation with audit trails, MasterControl and Greenlight Guru are often top contenders.

If you want, I can also give you:

1. a comparison table, or
2. a shortlist specifically for medical device field service versus general QMS.