Regulated Domains
Regulated domains
Agile software development methods were initially seen as best suitable for non-critical product developments, thereby excluded from use in regulated domains such as medical devices, pharmaceutical, financial, nuclear systems, automotive, and avionics sectors, etc. However, in the last several years, there have been several initiatives for the adaptation of agile methods for these domains.[69][70][71][72][73]
There are numerous standards that may apply in regulated domains, including ISO 26262, ISO 9000, ISO 9001, and ISO/IEC 15504. A number of key concerns are of particular importance in regulated domains:[74]
- Quality assurance (QA): Systematic and inherent quality management underpinning a controlled professional process and reliability and correctness of product.
- Safety and security: Formal planning and risk management to mitigate safety risks for users and securely protecting users from unintentional and malicious misuse.
- Traceability: Documentation providing auditable evidence of regulatory compliance and facilitating traceability and investigation of problems.
- Verification and Validation (V&V): Embedded throughout the software development process (e.g. user requirements specification, functional specification, design specification, code review, unit tests, integration tests, system tests).