Regulatory & quality,
finally in one place.
RAbuddy brings document control, eQMS, regulatory affairs and AI-powered authoring together, so your team ships compliant products faster and is always audit-ready.
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Everything regulated teams need
Every module works on its own and works better together. Turn on only the bundles you need.
Document center
Controlled document types, automatic numbering, templates and packages. Generate, review and publish approved documents from one reusable content library.
- Templates
- Numbering
- Content library
- Approved docs
AI-powered documents
Trained AI modules draft Clinical Evaluation Plans and more in minutes, ready for expert review.
Quality hub (eQMS)
CAPA, deviations, change control, audits, risk and suppliers, with live analytics.
- CAPA
- Deviation
- Change
- Audit
- Risk
Regulatory hub
Technical documentation, registrations, MAH, PRRC, management review and audit readiness.
Product development
Dev boards, Kanban projects and two-way Jira sync, linked to your QMS product records.
Workflows & traceability
Configurable approval workflows, training assignments and cross-record links from requirement to release.
RIM submissions
Build dossiers, track health-authority submissions and link them to your registrations.
See RAbuddy in action
A quick look at the screens your team will use every day.
Document center
312 controlled docs| Number | Title | Owner | Status |
|---|---|---|---|
| SOP-QA-014 | Document control procedure | Quality | Effective |
| WI-RA-031 | EU MDR registration work instruction | Regulatory | In review |
| TD-PRD-207 | Technical documentation, Class IIa | Regulatory | Approved |
| FRM-QA-088 | CAPA investigation form | Quality | Draft |
| PLN-CE-012 | Clinical evaluation plan | Clinical | AI draft |
21 CFR Part 11, without the paperwork
Turn on Part 11 controls for each tenant. Your existing flows keep working, and every signature and change is recorded.
- Electronic signatures: each signature records its meaning and timestamp, requires re-authentication, and is tied to the exact record version.
- Immutable audit trails record who changed what, when and from where, with before/after hashes.
- Record locking: approved records are locked, and only change control can create a new version.
- Signature manifests export as PDF or JSON for inspectors.
From draft to approval in four steps
Pick your modules
Turn on the bundles you need: documents, eQMS, regulatory or Part 11.
Draft with AI
Start from trained templates and your content library. Draft documents in minutes instead of weeks.
Review & sign
Approval workflows with compliant e-signatures and a full audit trail.
Stay audit-ready
Dashboards, traceability and exportable evidence, available whenever an inspector asks.
Works with your stack
Two-way Jira sync is available now. More connectors are on the way.
Questions, answered
No. RAbuddy is sold in bundles: documents, eQMS, regulatory, Part 11, RIM and AI modules. Turn on only what you need, and add more later without migrating any data.
Ready to make compliance your competitive edge?
Sign in to RAbuddy and see how fast regulated work can move.
Launch Tool