– User Requirements Specification
– Functional Specification
– Hardware & Software Design Specification
– Software Module Design Specification
– Application Software Production
– Module Software Test Specification
– Integration & Acceptance Test Specifications
– Verification Requirements & Design Specification
– Verifying Test Steps, Expected Outputs and Evaluation Criteria

 

• “Agile” software development and testing.

– The “principles” which act as the basis for agile. Agile versus process based development models such as “waterfall”. The “Scrum” as a based for agile implementation. Implementing the necessary agile structures and meetings. Product backlog, Sprint planning, the daily Scrum, the Sprint review, Sprint retrospective meetings explained.

• Extreme Programming  (XP).

– The objectives of extreme programming. Activities associated with extreme programming. The “rules” of XP. Environments where the implementation of XP is appropriate.

• Outline of the “Spiral Method” of Software Development & Validation.
• Control of Electronic Records and Electronic Signatures (US FDA guidelines).
• Managing Software Revisions.
• Performing a Gap Analysis. Master Validation Plan.
• Documentation.

• Computer Software Assurance (CSA). The changing approach to Software & Computer Validation by the US FDA.