This curriculum reflects the scope typically addressed in a focused internal workshop or structured capability uplift.
Module 1: Foundations of Compliance-Driven Requirements Engineering
- Distinguish between functional requirements and regulatory obligations under ISO 16175, identifying where overlap or conflict may occur in system design.
- Map recordkeeping principles from ISO 16175-1 to specific software capabilities such as metadata capture, audit trails, and retention scheduling.
- Evaluate existing software requirements specifications for gaps in compliance alignment using ISO 16175 maturity indicators.
- Integrate authenticity, reliability, integrity, and usability (ARIU) criteria into user story definitions and acceptance criteria.
- Assess organizational risk exposure when non-compliant requirements are approved due to cost or timeline pressures.
- Define boundaries between business requirements, technical requirements, and compliance controls to prevent scope creep in regulated projects.
- Negotiate trade-offs between agile development cycles and the need for documented, auditable requirements traceability.
- Establish a requirements governance framework that includes legal, records, and IT stakeholders in sign-off processes.
Module 2: Translating ISO 16175 Principles into Technical Specifications
- Convert high-level mandates like \
