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.