GAMP 5 and HIPAA Aren’t Just Buzzwords — They’re Our Standards
In healthcare software development, there’s no room for shortcuts. Functionality and design matter, but what truly defines a successful product is compliance, safety, and trust. That’s why at Cubex, we treat GAMP 5 and HIPAA not as checkboxes — but as working standards.
What Is GAMP 5?
GAMP 5 (Good Automated Manufacturing Practice) is a globally recognized guideline for validating automated systems in regulated industries — particularly healthcare and pharmaceuticals.
At Cubex, we use GAMP 5 to:
- Minimize risks for patients and providers
- Standardize development and testing processes
- Ensure full system validation and traceability
- Embed detailed documentation into every phase of development
Whether we’re building web platforms for clinics or B2B tools for medical startups, GAMP 5 ensures that quality is not just a goal — it’s part of the process.
Why HIPAA Matters
HIPAA (Health Insurance Portability and Accountability Act) is the gold standard in patient data protection in the United States. If your platform collects, stores, or processes sensitive health information, HIPAA compliance isn’t optional — it’s mission-critical.
Here’s how we build with HIPAA in mind:
- End-to-end encryption and access control
- Secure data storage and backups
- Full audit trails and activity logging
- Robust policies for data handling and incident response
For us, security isn’t an afterthought — it’s in the DNA of every system we create.
What This Looks Like in Real Projects
We’ve built dozens of healthcare products where GAMP 5 and HIPAA compliance were not just guidelines, but core success criteria. Just a few examples:
- 1+1 Cares — a platform for elderly care with strong data privacy requirements
- Checked In — a real-time doctor-finder app using live geolocation and secure bookings
- Aura Health — a mental health app serving over 6 million users, with HIPAA-level data protection baked in
Why It Matters to Our Clients
We don’t just “deliver projects” — we partner with our clients to ensure their solutions are technically excellent and legally sound. We understand the language of compliance, audits, investor expectations, and clinical validation.
When you work with Cubex, you get a team that:
- Knows how to build HIPAA- and GAMP-compliant architecture
- Provides detailed technical documentation
- Designs for scale and security from day one
Final Thought
GAMP 5 and HIPAA aren’t bureaucracy — they’re trust.
And in healthcare, trust is everything.
If you’re building a product that touches patient lives, you need more than just code — you need a partner who understands the regulatory landscape and builds with compliance from the ground up.
Let’s talk about how we can support your healthcare mission.
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