CASE STUDY
How Avvio Medical Built a Compliant, Scalable QMS with Propel
Streamlined document control, tighter training alignnment, and future-ready QMS expansion with Domain Systems and Propel
Executive Summary
Avvio Medical, a clinical-stage company focused on developing non-invasive treatments for urinary stone diseases, needed a centralized, compliant, and efficient Quality Management System (QMS) to support document control, training integration, and future expansion into supplier management and equipment tracking. Propel PLM QMS was ultimately the logical choice, as it was the only PLM/QMS solution on their short list. As such, it was ideally positioned out of the box to ensure regulatory compliance with standards such as ISO and FDA while maintaining quality throughout every stage of the product lifecycle.
Domain Systems was chosen as the system integrator for their deep expertise and long-time reputation for quality support. This helped Avvio successfully implement a structured document control system, improved compliance tracking, and introduced key configurations like a watermarking feature to track document versioning and enforce effective dates.
Client Case at a Glance
- Customer: Avvio Medical
- Industry: Biotechnology / Medical Devices
- Size: SMB manufacturer
- Location: San Francisco, CA
- Key Challenge(s):
- Implementing Propel PLM QMS for document control
- Compliance while ensuring a smooth transition for internal team.
- Results:
- Stronger Compliance: Improved document tracking and training alignment.
- Feature Enabled: Watermarking for effective date control.
- Scalable Roadmap: Foundation set for future QMS expansion.
The Goal: A QMS That Met Regulatory and Operational Needs
Avvio Medical’s primary requirement was a QMS that would manage compliance and operations effectively. Their objectives included:
- Training alignment with document changes for regulatory compliance
- Better navigation and search functionality for controlled documents
- Historical traceability of past versions and redlines for audits
- Scalability to expand into supplier management, CAPA, and equipment tracking
With Propel’s PLM and QMS solutions, Avvio sought a unified platform that could address these needs, in addition to supporting tighter cross-functional collaboration, improved operational efficiency, and seamless scalability for future growth.
The Solution: Domain Systems’ Expertise in Propel & Medical Device QMS
Domain Systems stepped in to bridge the gaps and drive the project to completion:
- Expert-led implementation: Once Domain’s consultants joined the project, they provided clear guidance, responsive support, and process alignment.
- Configured document control features to streamline document routing and approvals.
- Process streamlining: Worked through document control routing challenges to optimize approval workflows.
Results & Benefits: A More Usable, Compliant QMS
✔ Regulatory Compliance Strengthened: Effective document tracking and training alignment improvements
✔ Key Delivered: Watermarking feature for effective date control
✔ Scalable Future Roadmap: Set groundwork for future QMS module expansion
“We appreciate the assistance Domain provided with our Propel implementation. [Domain] was knowledgeable, detailed, and patient, and handled our project with a true partnership approach.
I would absolutely recommend Domain for future Propel implementation for other Medical Device Customers.“
Next Steps: Thinking About Propel for QMS? Let’s Talk.
If you’re considering Propel PLM for document control, compliance, or full QMS management, Domain Systems can help you navigate potential roadblocks and ensure a smooth transition.