Software
Documentation & Compliance
Software documentation is the foundation of regulatory compliance for digital health technologies. GSAP helps organizations develop clear, compliant, and traceable documentation that supports software development, verification, validation, regulatory submissions, and ongoing lifecycle management.
Our services include:
- Software Development Lifecycle (SDLC) Documentation
Development and review of Software Development Plans (SDP), software lifecycle documentation, revision management, software maintenance plans, and configuration management documentation. - Software Requirements & Architecture Documentation
Preparation of Software Requirements Specifications (SRS), software architecture documentation, detailed design specifications, and software safety classification justifications. - Software Risk Management
Development of software risk management plans, software risk analyses, software hazard assessments, and documentation supporting software safety classification. - Verification, Validation & Testing Documentation
Preparation of Software Verification & Validation (V&V) Plans, unit and system test protocols, software test reports, static and dynamic code review documentation, and known bugs management. - Traceability & Software Compliance Documentation
Development of Requirements Traceability Matrices (RTM), software change documentation, off-the-shelf software (OTS) assessments, and lifecycle traceability documentation. - IEC 62304 Compliance & Regulatory Readiness
Software compliance assessments, gap analyses, and preparation of IEC 62304 software compliance documentation supporting regulatory submissions and audit readiness.
Ready to Move Forward?
Whatever your next milestone is, let’s bring the right expertise together to get you there
Silvian Shama
Business Development Manager
Pharma & Advanced Therapies
Add. 2 Shaar Palmer St., Haifa, Israel