Inform yourself. Enhance your understanding. Improve your personal capabilities.
- Software Validation explained.
- Over 400 pages of information.
- Inform yourself, from the convenience of your desktop, laptop, tablet, mobile.
- Use as a support if training your peers.
- 50% OFF SALE. Standard price $149. Available for $75. Saturday 24th / Sunday 25th October.
Contents:• Introduction to Software Validation (Objectives & Approaches to 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.
• 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.
• Computer Software Assurance (CSA). The changing approach to Software & Computer Validation by the US FDA.
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