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Course overview
This fully interactive three-day Software Validation training course provides attendees with the knowledge and skills they need to comply with European, US, and Worldwide software validation requirements. Delivered by expert tutors, this highly practical course is designed to equip learners with a clear roadmap to plan, execute, and maintain compliant validation activities for software and computerised systems used across QMS, Production, Testing, and Distribution. The course is based on the latest FDA and GAMP guidelines and is designed to ensure that validation effort is proportional to risk and to eliminate unnecessary ‘pro-forma’ testing.
Throughout the course, learners engage in interactive group exercises and case studies that mirror industry-specific scenarios, guiding them step-by-step through the full validation lifecycle. This hands-on approach ensures that concepts are clearly understood and internalised. Each exercise and case study is designed to reflect European, FDA, and global regulatory expectations. As a result, learners are equipped to return to their workplace with the clarity, capability, and confidence to implement robust, compliant validation practices that align with regulatory expectations and current best practice.
We can tailor the training to meet your specific training needs and incorporate examples from your processes and procedures into the training programme as required.
Who's It For?
The training is particularly beneficial for those across the Medical Device, Pharmaceutical, and Life Sciences sectors involved in:
- Validation of Software Systems
- Validation of Process Equipment or Test Equipment
- Ensuring Data Integrity and Part 11 Compliance
- IT in a regulated environment
A good standard of written and spoken English is important to engage effectively with this programme.
What you'll learn
On successful completion of the training, learners will be able to:
- Identify the regulatory requirements for software validation across Europe, the US and globally
- Apply the GAMP categorisation model to classify software systems appropriately
- Apply the latest FDA guidance (2025) and GAMP 5 edition 2 to implement validation activities in proportion to risk and to avoid unnecessary documentation and testing
- Implement the V-Model to structure validation activities and ensure traceability
- Design a software validation master plan
- Conduct a risk-based assessment to guide the level of validation effort required
- Write realistic and meaningful User Requirements Specifications (URS)
- Integrate Design Qualification (DQ) into the validation lifecycle
- Write software IQ, OQ and PQ protocols in line with the appropriate risk level
- Construct a Requirements Traceability Matrix (RTM)
- Execute software testing and interpret results aligned with statistical principles
- Apply 21 CFR Part 11 guidance and ensure Data Integrity compliance
- Leverage vendor-supplied documentation to reduce duplication of effort
- Develop and deliver validation reports that meet regulatory standards
- Define strategies for maintaining the validated state of computerised systems
These outcomes ensure learners return with practical skills and knowledge necessary to design, execute and sustain compliant software validation in a regulated environment.
Study method
- In-class
- Virtual
- Blended
- Online
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Duration study load
- 3 training days
Delivery
This programme is delivered by Classroom, Virtual Training, or In-Company training
Assessment
To consolidate learning and reinforce key concepts, learners complete a post-course assessment. The assessment;
- Checks understanding of the course content and practical scenarios
- Assesses practical understanding and application
- Is completed within one week of course completion
Successful learners receive a Certificate of Achievement, in addition to their Certificate of Attendance
Testimonials
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Deirdre M"Course was very well delivered with a knowledgeable and experienced provider. Real life experiences and scenarios benefited the delivery of the course."
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Yasser A"The course provided a comprehensive overview of software validation principles. - Mr. John delivered the course with great expertise and professionalism."
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Jakub S" am very happy and satisfied I took this course. Profesionalism of the tutor, quality of materials - one of the best courses I've had so far."
Additional information
How do we train and support you?
Our training approach is practical, highly interactive, and discussion-based, with flexibility to meet organisational needs
- Pre-training consultation for In-Company courses to tailor content to organisational needs
- Emphasis on industry-specific application through practical exercises, case studies, and group activities that reinforce key concepts and encourage active participation.
- Access to comprehensive course material that is regularly reviewed and updated to reflect the latest industry standards and guidance.
- Live training is available virtually or delivered onsite to suit the needs of the team
- Real-time support from expert Tutors
Class sizes are generally limited to 12-15 participants to support personalized learning and individual support.
Abbreviations used in this document:
- CPD: Continuous Professional Development
- DQ: Design Qualification
- GAMP: Good Automated Manufacturing Practice
- IQ: Installation Qualification
- MVP: Master Validation Plan
- OQ: Operational Qualification
- Part 11: 21 CFR Part 11 Electronic Records and Electronic Signatures
- PQ: Performance Qualification
- RTM: Requirements Traceability Matrix
- URS: User Requirements Specification
Subjects
- The Need for Software Validation
- European and FDA Regulations and Guidance on Software Validation
- Software Validation Regulations interactive quiz – New
- The latest FDA Guidance on Software Validation – New
- Group Discussion the latest FDA Guidance on software validation – New
- The GAMP Approach to Software Validation
- GAMP Categorization case study – New
- The V Model Approach
- V Model Approach interactive exercise
- Software Validation Planning – designing master validation plans
- Writing Software Validation Rationales – New
- Case Study – determining what needs to be included in the MVP for a specific manufacturing process – New Content
- Requirements Specifications – Case Study writing a URS
- Application of Risk Analysis to Software – Updated Content
- Software Design Qualification
- Requirements Tracing – using the RTM to plan qualification testing
- Case Study – writing an equipment IQ Protocol
- Software Testing and Software Test Environments
- Software Testing Interactive Exercise
- Case Study – writing an equipment OQ Protocol
- Application of Statistics to Software Validation – New Content
- Statistical Rationale for Samples Sizes – Updated Content
- Electronic Records and Electronic Signatures
- 21 CFR Part 11 Interactive Exercise
- Application of the FDA Guidance on Part 11
- Data Integrity and Software Validation – New
- Software Performance Qualification
- Case Study – writing a Software PQ Protocol – Updated Content
- Leveraging Supplier documentation for off-the-shelf systems – Updated Content
- Validation Reporting – How to Report on Software Validation testing – New
- Maintaining the Validated State – Updated Content
- End of Course Assessment. – New
About SQT Training
We are a specialist provider of bespoke training programmes that help organisations become leaner, more compliant and more progressive. For over 30 years, we’ve brought the latest thinking, the leading techniques and the most experienced industry experts into ambitious organisations, large and small, throughout Ireland, the UK, and beyond.
We trained some of the very first ISO Lead Auditors, and many years ago, we coached the earliest adopters of Lean Six Sigma.
We empower people with the capability to help their organisations reach the highest standards, maintain compliance, and drive efficiency.
Our programmes are renowned for their dynamic, practical, real-world approach and are built on a foundation of theory and practice that works. That’s why the likes of CRH, eBay, Glanbia, Kerry Group, Medtronic, Musgraves and Pepsi trust us to train their people – over 65,000 in 27 years.
As well as In-House programmes we run virtual and blended public courses.
