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Project activities applicable to standard software packages

  • 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.
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