Software Validation

This three-day programme combines interactive learning, case studies and group exercises to build validation skills across the software lifecycle through practical application and active participation. 

Day 1 

• The Need for Software Validation 
• European and FDA Regulations and Guidance 
• Software Validation Regulations Quiz 
• The latest FDA Guidance on Software Validation 
• The Computer Software Assurance (CSA) approach 
• The GAMP Approach and Software Categorisation  
• The V Model Approach to Software Validation  
• Software Validation Planning 
• Designing Master Validation Plans (MVP) 

Day 2 

• Writing User Requirements Specifications (URS) 
• Risk Analysis of Software Applications 
• Software Design Qualification (DQ) 
• Preparing a Requirements Traceability Matrix (RTM)  
• Writing IQ Protocols  
• Software Testing and Test Environments  
• Writing OQ Test Cases 
• Applying Statistics to Validation 
• Statistical Rationale for Sample Sizes 

Day 3 

• Electronic Records and Electronic Signatures 
• 21 CFR Part 11 Compliance  
• Data Integrity Principles and Practice 
• Writing Software PQ Protocols 
• Leveraging Supplier Documentation 
• Validation Reporting and Maintaining the Validated State 

The training involves practical exercises throughout covering all of the above topics, with learners encouraged to work on examples from their own workplace as part of these practical exercises.  If required, content may be tailored to reflect your organisation’s specific processes, risk profile and regulatory setting. 

The training is particularly beneficial for those across the Medical Device, Pharmaceutical and Lifesciences 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. 

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. 

Our tutors are industry-leading validation specialists with decades of experience in life sciences compliance. Each tutor brings a wealth of industry experience, sector-specific insights and a passion for practical training. Their focus is on building learner confidence through engagement, hands-on exercises and personalised support. 

Learners benefit from expert instruction, relatable examples and individualised feedback throughout

• 

  John Lafferty

  John Lafferty is a Quality professional with over 25 years expe...

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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 

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. 

Learners who complete this course often continue to deepen their skills in: 

• 21 CFR Part 11 Electronic Records and Electronic Signatures and Data Integrity 
• Process Validation & Equipment Validation 
• Process Validation for Medical Device Manufacturing 
• Validation of Software as a Medical Device and EN IEC 62304 
• Medical Device Risk Management and ISO 14971:2019 
• Pharmaceutical Quality Risk Management and ICH Q9 
• Technical Writing Skills 

Abbreviations Used in This Document 

• CSA: Computer Software Assurance  
• DQ: Design Qualification 
• GAMP: Good Automated Manufacturing Practice 
• ICH Q9: Guideline on Quality Risk Management  
• 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