- Define the scope of the system and it’s strategic objectives.
- Perform a preliminary evaluation of technology
- Complete the change control forms and approvals, including obtaining the approval of QA
- Prepare a system requirement specification deliverable
- Prepare and approve a validation plan
- Conduct a system risk study and a criticality/complexity study and document the results. Any new requirements that result from the risk study must be added to the system requirements specification deliverable.
- Approve the system requirements specification deliverable
- Select the software package
- Revisit the risk study
- Prepare and approve the system specification deliverable in full
- Prepare a technical design specification deliverable
- Critical algorithms, parameters, and formulae
- Data integrity, security, accuracy, and reliability
- Perform design reviews, including technical design inspections
- Approve the technical design specification deliverable
- Prepare validation/qualification protocols and the applicable procedural controls
- Build the application
- Inspect the developed code. The focus of this inspection is on the critical algorithms and parameters
- Conduct an IQ
- Conduct an OQ
- Prepare a summary report
- Update the documentation regarding references to application software, associated versions, and user manuals.
Regards