Scale-ups. Pace, access and one platform.
Startups of 25 people or more with an ISO 13485 QMS, from final development through their first device on the market. In the scale-up phase they need pace and access, with quality and regulatory embedded into every process, and every process on one platform.
What gets in the way.
- Quality and regulatory risk becoming a silo just as the business speeds up.
- Processes spread across tools, departments and locations.
- Management, project managers and QARA each need something different from the same system.
One platform, built for this stage.
A true QMS enables the business and is one with it. OPRA Flow blends these aspects: a fully mobile platform for work in any situation, and intuitive workflows and interfaces that bring higher adoption across departments. OPRA Flow does not only serve QARA.
What each team gets
- Management
- Live management reviews
- Project managers
- Resource planning and a clear view of blockers
- Quality and regulatory
- A process-driven approach, with digital workflows that democratise it
- OPRA Docs
- Every process and record on one platform, on desktop or mobile.
- OPRA Events
- Handle any quality event as volume grows, with quality built into the workflow.
- OPRA Plan*
- Resource planning and blockers for project managers.
- OPRA Regs*
- Automates FDA submissions, saving hundreds of manual hours on eSTAR applications.
- OPRA AI
- Removes the mundane work so teams keep their pace.
FDA submissions, automated. Hundreds of manual hours saved.
OPRA Regs automates FDA submissions and takes the manual work and anxiety out of filling in eSTAR applications.
* The entire work can be done in OPRA Docs with OPRA AI. Modules marked * are purpose-built interfaces that make the work easier than current standards.
Start small. Grow on the same platform.
- Begin with
- OPRA Docs and OPRA Events, with the OPRA AI layer
- Grow into
- OPRA Start
- OPRA Build*
- OPRA Control*