Document control, quality events, and electronic signatures — designed to support compliance with IEC 62304 and 21 CFR Part 820 without slowing down your release cadence.
You ship software every two weeks but your QMS still thinks you're waterfall. Change orders take longer than the sprint.
IEC 62304 traceability means manually mapping requirements to test cases in a spreadsheet that's already out of date.
Cybersecurity documentation is an afterthought because your QMS has no concept of SBOM or threat modeling.
Every FDA submission requires re-assembling your software documentation from five different tools.
Your team treats the QMS as a checkbox exercise because it adds friction to every commit, not value.
Not a hardware QMS with a "software module" bolted on.
Version-controlled SOPs, work instructions, and software documentation with full approval workflows and audit trails.
Sign-off on documents and quality records with signatures designed to support 21 CFR Part 11 requirements. Every action logged.
Track bugs, anomalies, and nonconformances as quality events. Configurable CAPA templates with root cause analysis and effectiveness checks.
Qualify and monitor your vendors, cloud providers, and third-party components with risk-based workflows.
Every document change, approval, and signature is recorded permanently. No gaps, no edits, no surprises during an audit.
Pre-built templates to help you get started with the documentation your regulatory framework requires. Customize as you grow.