Software Validation.

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

Requirements and current best practices.

- Software Validation requirements & practices.
- 400+ pages of 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, via your desktop, laptop, tablet, mobile.
- Price $119.

“Software Validation” – 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.

• Documentation Management.

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

… Price $119 …

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Extract Pages … Software Validation:

Validation of Software

Principles of Software Validation

Agile Software Development and Testing Process

Software Development

Functional and Non-Functional Software User Requirement

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