Software Development: Precision for Life Sciences
In the regulated environment of pharma, biotech, and medical device industries, software development comes with unique challenges. Custom solutions must not only be functionally convincing but also designed from the outset for the highest quality standards and subsequent GxP compliance.
cube one GmbH is your specialized partner for GxP-compliant software development. We develop custom applications and database solutions perfectly tailored to the life science environment – in accordance with GAMP 5 and ISO 13485.
Quality from the Start:
Our software development follows a clearly defined, GxP-compliant process to ensure product quality and compliance requirements:
- Requirements Analysis (URS): We jointly define your User Requirement Specifications (URS) and establish the foundation for validation.
- Agile Development & Documentation: We use agile methods (e.g., Scrum), with GxP-compliant documentation (Design Specifications, test plans) created parallel to development.
- Quality Assurance & Testing: Comprehensive testing at every phase ensures functionality, security, and data integrity.
- Validation Support: The software we develop is already optimized for final software validation.
Our Expertise in GxP Software Development:
We offer a comprehensive range of software development services specifically tailored to the needs of the life science sector:
- Custom Database Solutions: Development of tailored applications for capture, management, and analysis of GxP-relevant data.
- Integration & Interfaces: Connection of new software to existing laboratory systems (LIMS, ELN) and ERP systems.
- Automation & Reporting: Tools for process automation and GxP-compliant generation of reports and audit trails.
- Technology Focus: Development with modern, future-proof technologies (e.g., low-code/no-code, web applications, AI agents) for rapid deployment and easy maintenance.
Our Software Development Services for GxP Applications:
We provide tailored solutions to realize your custom GxP applications – from conception to validation-ready delivery:
1. GxP Concept & Requirements Capture (URS):
Detailed analysis of your business requirements to create GxP-compliant User Requirement Specifications (URS) and derive functional specifications for software development.
2. Agile & GxP-Compliant Development:
Implementation of your custom software solution using agile methods, with GxP documentation created in parallel and integrated into the development process.
3. Quality Assurance & Validation Readiness:
Extensive internal testing and verification to ensure software quality and guarantee complete validation readiness of the product.
4. Integration & Change Management:
Seamless integration of the new software into your existing IT architecture (interfaces, data migration) and establishment of GxP-compliant processes for future changes.
5. Development of Specific GxP Systems:
Implementation of critical applications (e.g., database solutions, LIMS interfaces, workflow tools) that are GxP-compliant and meet the highest data integrity standards.
Contact us today for personalized consultation on software development.
