Software Validation.

Information & Training Presentation.

Software Validation explained.

- Methods and support requirements for effective Software Validation explained.
- Use to develop your personal understanding.
- Use as a support if providing training to others.
- Step through at your own pace, from the convenience of your desktop, laptop, tablet or mobile.
- Over 400 pages of information, provided in a visual, easy to understand format.
- Price $59*.

* Recommended price of $129. Available now for $59

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– 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.

• Control of Electronic Records and Electronic Signatures (US FDA guidelines).
• Managing Software Revisions.
• Performing a Gap Analysis. Master Validation Plan.
• Documentation.