Software verification and validation course

Units 10 units. Level level. Course handbook -- Jump to section -- Description Availability Learning outcomes Content Assumed knowledge Assessment items Compulsory requirements Contact hours Description This course focuses on software verification and validation throughout the software life cycle.

Topics covered in this course will include reviews, inspections, formal verification, testing techniques, and testing frameworks Availability Callaghan Semester 1 - Connect with us on social media. Assess real-world lessons learned and identify the benefits of an SDLC, including time to market. Understand FDA design control guidance, including traceability and design review requirements.

Evaluate and recommend testing-level strategies unit, integration, system, user. Understand methods development and documentation requirements. Create a plan for configuration and change management, including defects and issues management. Related Courses New! Online Training Schedule This class is delivered across 4 consecutive days. Request a Proposal Or ask a question! Get answers right now. Call 1. System Verification and Validation Training covers all aspects of systems engineering related processes to verification, validation and testing.

System Verification and Validation Training details validation and verification processes. Validation is the process of determining that the requirements are the correct requirements and that they form a complete set of requirements this is done in the early stages of the development process. The course provides an overview of the FDA and European requirements with practical exercises covering the implementation of those requirements.

The course covers the application of these requirements to the validation of both computer hardware and software systems used in Manufacturing, QA, Regulatory and the Control of Processes. Laws, Regulations and Guidelines for Software Validation The course will examine the regulations surrounding the current requirements for the validation of software and computer systems used in Manufacturing, QA, Regulatory and the Control of Processes, both prospectively and retrospectively.

The use of the current GAMP guidelines as a method of compliance with the regulations will be discussed. Electronic Signatures and Records This section of the course introduces the regulations governing the use of Electronic Records and Electronic Signatures in a regulated environment. Details of the requirements of 21 CFR 11 will be examined and the current expectations of the FDA with regard to implementation will be discussed. Risk Assessment This section will look at the objectives for risk assessment, and will discuss the various guidelines and techniques involved.

The programme will cover the implementation of risk assessment to ensure critical risks are identified and the correct level of validation is carried out.