Aims
Develop a new software development process including all supporting procedures. Implement, configure and validate a new toolset to support the process. ISO13485 (including ISO62304, 21CFR820 and GAMPS) development. The process had to support five sites working collaboratively (USA, UK, Germany, Romania and India) Time scale of nine months.
Role
Lead implementor and internal quality consultant.
Key Points
- Develop a collaborative software development process compliant with ISO 9001 and ISO 13485 (including ISO 62304, 21 CFR 820, 21 CFR Part 11, and GAMP5).
- Ensure tailoring of the process is intuitive and supports all project types.
- Create all supporting procedures.
- Implement new tools to support the process, ensuring compliance with 21 CFR Part 11.
- Provide ongoing quality support and guidance.
Successes
- Robust tool implementation (configure Jira and Bitbucket), guiding workflow throughout the process. Successful audit of process to ISO9001 and ISO13485.
- Ease of adoption of all sites to new processes and tools. Ease of tailoring of process dependant on project and/or product type.
- Initial implementation of ISO27001 for software cloud development.
Skills
- ISO 9001 requirements.
- ISO 13485 requirements (including ISO62304, 21CFR820,21CFR part11 and GAMP5)
- Process mapping
- Form creation (Jira)
- Document creation
- Business change management
- Software tool validation
- GAP analysis
- Training
Tools used
- Jira
- Confluence
- SAP
- Word
- Excel
- PowerPoint
- Visio