Summary
Resilience, a biomanufacturing innovator, faced the challenge of building regulatory maturity for full clinical development from assay, automation, devices though software from scratch. With no prior FDA-regulated development experience internally, they needed a way to rapidly build and implement a Design History File (DHF) management system that met U.S. regulatory expectations and was reusable for their fast-growing product lines. By leveraging BeanStock Ventures’ Grassroots DIY Regulatory Kit and expert-led strategy execution, Resilience transitioned from R&D experimentation to a compliant, reusable, scalable development process—positioned for long-term FDA success.
Challenge
Resilience was entering its first FDA-regulated development effort. Despite robust biomanufacturing operations, the team lacked an established regulatory framework particularly around traceability and documentation for reusable and platform products. The main challenges included:
- No pre-existing or limited DHF or traceability tools
- Limited familiarity with FDA QMS guidance
- An urgent need to structure their processes without disrupting their R&D cadence
- Internal pressure to move quickly without errors or rework
BeanStock Ventures Fast Track Solution
🧭 Regulatory Strategy
We began with an internal strategy alignment to define scope, safety classification, and QMS fit. A staged regulatory roadmap was created to ensure a fast start with scalability built in for future product extensions.
📄 Documentation & Compliance
Using our Grassroots Dx DIY Kit, the Resilience team received:
- 30 plus mature, pre-formatted templates compliant with FDA and IEC standards
- Guidance for planning, risk management, V&V, usability, tool validation, and traceability
- Example content and organized subsystems that enabled faster adoption and accurate completion across multidisciplinary teams
🚀 JAMA Integration Execution
Although this phase did not include a 510(k) submission, the foundation laid ensures that future submissions can move faster for them and their clients—especially with the integration-ready DHF structure in JAMA, which supports scalable documentation, reuse and FDA audit-readiness.
By aligning the DIY Kit with JAMA implementation, Resilience minimized tool migration, integrated DHF artifacts into their enterprise system, and gained the ability to automate and reuse documentation across products.
Outcome
| Metric | Outcome |
|---|---|
| Time to Initial DHF Build | < 6 weeks for full software DHF structure |
| Templates Adopted | 30+ across planning, assay, software and systems development, V&V, usability |
| Staff Onboarding Time Saved | ~3 months compared to building templates from scratch |
| System Reuse Plan | Implemented with traceability in JAMA |
| Project Advancement | Seamless handoff to Stage 2 for systems DHF + training |
💬 Client Feedback
“Being our first time with true software product development, we appreciated that the tools provided by BeanStock Ventures’ DIY Software Kit integrated with our existing processes so that we did not need to migrate. We were able to reach more mature processes quickly.”
— Matthias Merten, Director, Systems Engineering, Resilience
🧠 Why GrassrootsDx?
- Rapid Regulatory Uplift –Complete reusable Design History File structure in under 6 weeks.
- DIY Kit + Expert Guidance – Combined 30+ FDA/IEC-compliant templates with hands-on coaching for fast adoption.
- Seamless Tool Integration – DHF and traceability which integrates within enterprise tools such as JAMA and Greenlight Guru, eliminating migration headaches.
- Reusable & Scalable – Designed processes and documentation for repeat use across multiple products and programs.
- First-Time FDA Success Enablement – Tailored implementation for teams with no prior regulated development experience.
- Future-Ready Compliance – Built-in structure for faster 510(k) or De Novo submissions and easier FDA audits.
📩 Want to accelerate your QMS implementation?Let’s build together.
📧 marketing@beanstockventures.com