Addressing Key Challenges in Regulated Software Development
The development of software solutions for regulated industries like pharmaceuticals and medical devices (GxP and SaMD) presents unique challenges:
- Documentation Overload: Extensive regulatory requirements lead to voluminous documentation, straining resources and introducing risk.
- Slow Update Cycles: Traditional development methods often result in lengthy update cycles, hindering responsiveness to market and regulatory shifts.
- Documentation-Code Divergence: Discrepancies between official documentation and the evolving codebase can lead to compliance issues.
Our Solution: Best Practices and Integrated Tooling
Our approach leverages industry best practices and a versatile toolset to streamline the development process, ensuring compliance and efficiency:
Core Principles
- Shift-Left Testing: We adopt a test-driven development (TDD) approach, integrating testing and quality assurance early in the development lifecycle.
- Integrated Development Environment (IDE): We utilize a unified IDE that seamlessly connects requirements, design, testing, and code, ensuring traceability and consistency.
- Test Automation & Monitoring: Automated testing processes and on-demand documentation generation save time and reduce errors. Proactive monitoring tools identify and resolve issues early.
Technical Foundation
- Git Version Control: Comprehensive version control for all development artifacts (requirements, design, code, tests) ensures traceability and compliance.
- Documentation as Code: Treat documentation as an integral part of the development process, maintaining it within the version control system alongside the code.
- Continuous Verification & Validation: Testing and monitoring components are designed into the process to enable ongoing verification and validation.
Versatility and Customization
Our solution is adaptable and can be tailored to various development environments (e.g., Azure DevOps, Modern Requirements, GitHub, GitLab) and integrated with other relevant applications (e.g., Veeva or JAMA).
Benefits
By adopting our approach, you can achieve:
- Accelerated Development: Streamlined processes and automation lead to faster development cycles.
- Enhanced Compliance: Rigorous version control, traceability, and automated testing ensure adherence to regulatory requirements.
- Improved Quality: Early and continuous testing results in higher quality software.
- Reduced Costs: Automation and efficiency gains lower development and maintenance costs.
Contact Us
Ready to optimize your GxP and SaMD development process? Contact us today to learn more about how our tailored solutions can benefit your organization.