Information | current Best Practices.“Nice simple explanation of Software Validation”. (B. Murphy. Quality Engineer. J & J).
- Software Validation requirements & current best practices.
- 400+ pages of visual (text and graphics) information.
- Use to enhance your personal understanding, for personal professional development, as a support in the training of your work peers.
- Access online, when and where suits, on your personal devices, your desktop, laptop, etc..
- Extended price reduction. Available for $59.
- (Standard Price $119. Available for $59 from Friday 30th July through to Sunday 1st August).
Contents:• Introduction to Software Validation.
• Principles of Software Validation.
• Categories of Software (GAMP5 guidelines to categorizing Validation).
• Software development Life Cycle (Waterfall and V-Shaped models).
– 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.
• The “Spiral Method” of Software Development & Validation.
• Electronic Records and Electronic Signatures (US FDA guidelines).
• Managing Software Revisions.
• Performing a Gap Analysis. Master Validation Plan.
• Computer Software Assurance (CSA). The changing approach to Software & Computer Validation by the US FDA.