Why I'm Doing This
After years in MedDev and pharmaceutical quality systems, I've watched small and mid-sized companies struggle with a persistent problem: implementing a Quality Management System shouldn't require a six-figure budget and a year of consulting, but it does.
Enterprise QMS licenses cost a lot. Implementation takes 6-12 months. Customization requires specialized developers (e.g. SalesForce). The result? Promising biotech or SaMD startups delay compliance, rely on Excel spreadsheets, or face regulatory issues, not because they don't value quality, but because the tools are out of reach.
Meanwhile, the core quality management processes are well-established and could be standardized. Change control, CAPA, document management, audit trails—these workflows are defined by FDA, EMA, and ISO standards. They shouldn't be luxury items.
So I decided to build an open-source alternative. One problem: I'm not experienced as a web developer.
My Background
I have software engineering experience, but more in embedded systems and control systems. I've written code that runs on particle accelerators and safety equipment. I understand software architecture, data structures, and regulatory requirements intimately.
What I don't have is years of Spring Boot, Angular, or enterprise web application experience. I'm learning as I go, heavily leveraging AI tools, documentation, and a lot of trial and error.
The Technical Stack
I chose technologies based on what seemed most suitable for an enterprise QMS:
Backend: SpringBoot
- Mature ecosystem for enterprise applications
- Strong support for security and transactions
- Good documentation (critical when learning)
Frontend: Angular
- Component-based architecture fits QMS workflows
- TypeScript for better code quality
- Angular Material for UI consistency
Database: PostgreSQL
- Reliability for regulated environments
- Strong audit trail capabilities
Core Features Built:
- workflow engine with approval chains
- Change control management
- Task management with workflows
- Audit trails
What I've Learned Building This
AI tools can help you build a prototype if you have domain expertise. I use AI assistance extensively to accelerate learning patterns I don't know yet. When I understand what needs to happen (a multi-step approval workflow with role-based assignments), but not exactly how to implement it in Spring Boot, AI helps bridge that gap.
Domain expertise matters more than I expected
The hardest parts weren't the technical implementation. They were understanding what quality professionals actually need. What makes a change control workflow useful? How should approval routing work? What audit trail details matter for compliance?
I bring years of experience with these questions.Architecture decisions are critical early
Even without deep web dev experience, I knew to separate concerns: entities, repositories, services, controllers. I knew workflow state needed to be separate from business entities. I knew audit trails had to be immutable.
Software engineering principles transfer across domains.
Where I Need Help
I'm not building this alone, that would be foolish. I need:
- Software architects who can review the design and suggest improvements
- Developers interested in regulated industries who want to contribute
- Quality professionals willing to beta test and provide feedback
- Anyone who's built enterprise workflow systems and can spot issues I'm missing
The goal isn't for me to become a senior web developer. The goal is to combine my domain expertise with a community of people who have complementary skills.
Why Open Source?
Open source solves multiple problems:
- It attracts talent I can't hire alone
- It builds trust in regulated industries (transparent code, community validation)
- It serves the underserved (small companies who'll never buy Veeva)
- It creates a foundation for commercial services (implementation, hosting, support)
If you're interested in contributing, have experience in regulated software, or just want to follow along, I'd love to connect.
The code will be on GitHub soon. For now, I'm documenting the journey and learning in public.
Top comments (0)