Aims
Ensure that all new and upgraded software tools meet business requirements and are fit for purpose. Implement the process initially in three months with ongoing validation projects.
Role
Lead implementer
Key Points
- Introduce a consistent approach to software tool validation to ensure business requirements are met.
- Allow for validation of in-house developed tools to benefit from using the multi-site software development process.
- Ensure consideration of regulations such as 21 CFR Part11 is always made.
Successes
- The process was implemented in three months.
- Several software tools have been validated including Jira, Confluence, and Confluence export to SAP.
Skills
- Business requirements
- Validation test creation, including acceptance.
- Criteria
- Validation exceution
Tools used
- Confluence
- Jira