“Software Validation”.

Software Design Specification | User Requirements | Computer Software Assurance | Validation Models | Principles of Validation | Documentation | Software Validation, …


Information & Training Material – For You, your work Colleagues, your Employer.


“Nice simple explanation of Software Validation”.  (B. Murphy. Quality Engineer. J & J).

Software Validation Training

Requirements and current best practices.

    • Software Validation requirements & current best practices.
    • 400+ pages of information & training.
    • Enhance your personal understanding.
    • Use to support the training of your work peers.
    • Access online, when and where suits, via your desktop, laptop, tablet, mobile. 

“Software Validation” explains:


• 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.

• Documentation.

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


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Available now for $59.

50% OFF SALE – Reduced price available from Monday 11th to Friday 15th October 2021. (Standard price $119).

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Sample pages:

Validation of Software

Validation of Software

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