Software Validation

Course details

The main objectives of this course are to give attendees a grounding in the principles of Software Validation, Computer Systems Validation and the latest requirements for Electronic Records and Electronic Signatures. 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. The course also covers the latest FDA Requirements and Guidance on Electronic Records and Signatures (21 CFR Part 11) and Quality Risk Management as applied to Software Validation and Computer Systems Validation.

Learning Outcomes

On successful completion of this training course, delegates should be able to:

• Apply the principles of Software Validation and Computer Systems Validation.
• Implement the Validation Life Cycle approach to software and computer systems
• Apply Quality Risk Management techniques.
• Generate key validation documents such as URS, FDS, VMP, IQ, OQ and PQ.
• Apply the requirements of 21 CFR part 11 in relation to Electronic Signatures & Records.

Course Programme

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. Both FDA and EU regulatory guidelines will be discussed with regard to the Medical Device and Pharmaceutical industries. The use of the current GAMP guidelines as a method of compliance with the regulations will be discussed.

The Software Validation Life Cycle

The life cycle from design, through construction, installation and live start-up for a typical software project will be described with details on the contents of key documents / activities such as URS, FDS, VMP, IQ, OQ and PQ.

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.