Laboratory Software Validation

This programme introduces learners to the full lifecycle of laboratory software validation, from planning and risk analysis through to maintaining the validated state. Case studies and exercises reinforce each stage of the process. 

Day 1 

• The Need for Software Validation in the Laboratory 
• European and FDA Regulations and Guidance 
• Latest FDA Guidance on Software Validation 
• Group discussion on new guidance 
• The GAMP Approach 
• The V Model  
• Designing Master Validation Plans 
• Writing User Requirements Specifications (URS)  
• Applying Risk Analysis 
• Software Design Qualification 
• Requirements Tracing and RTM for testing 

Day 2 

• Writing an Equipment IQ Protocol  
• Software Testing and Software Test Environments 
• Interactive Software Testing Exercise 
• Writing OQ Protocols  
• Statistical Rationale for Sample Sizes 
• Electronic Records and Electronic Signatures and 21 CFR Part 11 
• Applying FDA Guidance on Part 11 
• Data Integrity and Software Validation 
• Writing Software and Laboratory PQ Protocols  
• Leveraging Supplier Documentation 
• Validation Reporting 
• Maintaining the Validated State 

The training involves practical exercises covering all relevant 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. 

Abbreviations. 

CFR - Code of Federal Regulation (US Federal Law)
GAMP - Good Automated Manufacturing Practice (Industry Guidance)
HLPC - High-performance Liquid Chromatography 
IQ - Installation Qualification
LIMS - Laboratory Information Management Systems
MVP - Master Validation Plan
OQ - Operational Qualification
PQ - Performance Qualification
URS - User Requirements Specification 

This programme supports those responsible for laboratory software validation by providing proven methods, tools and exercises that build confidence and competence.  

Suitable participants include: 

• Laboratory Managers, Supervisors and Technicians 
• Laboratory staff involved in the validation of laboratory systems, equipment and software 
• IT personnel supporting laboratory systems 

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 and interpret regulatory requirements for Laboratory Software Validation 
• Categorise laboratory software in line with GAMP guidance 
• Apply the V Model to software validation projects 
• Design and implement a Master Validation Plan (MVP) 
• Develop and assess User Requirements Specifications (URS) 
• Evaluate risks using Quality Risk Management principles 
• Apply FDA 21 CFR Part 11 requirements to electronic records and signatures 
• Implement Data Integrity requirements 
• Create and execute IQ, OQ and PQ test protocols 
• Utilise vendor documentation effectively in validation activities 
• Report effectively on software testing results 
• Maintain the validated state of laboratory systems 

These outcomes ensure that learners return with the practical skills and knowledge necessary to implement, manage and maintain compliant laboratory software systems. 

This course is delivered by tutors with deep expertise in laboratory systems and validation practices. 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 continuous support and guidance from tutors who understand the practical challenges of laboratory software validation. 

John Lafferty

John Lafferty is a Quality professional with over 25 years experience in the medical device and pharmaceutical industry. John joined SQT as a tutor in 2007. Prior to that, John spent many years working in the Medical Devices/ Pharmaceutical sectors – the final six years of which were as a Senior Manager of a multinational Medical Devices plant where he managed the Quality and Regulatory Systems. John completed his Lean Six Sigma Black Belt training through SQT in 2009 and derives great benefit from applying the techniques that he learned to Risk Management and Validation in a Life Sciences setting. “It is great to be able to bring this knowledge, and the experience gained from ongoing involvement with Life Sciences companies, into the classroom,” he says.

John passionately believes that the key to success in Life Sciences Manufacturing is the relentless application of Risk Management, Variation Reduction and Good Validation Practices. As the SQT tutor for Technical Writing Skills, John believes that good written communication skills are vital for any Life Sciences professional.

John holds the following qualifications: a Bachelor of Technology in Manufacturing Technology, a Six Sigma Black Belt, a Certificate in Training & Continuing Education and a Certificate in Quality Management. John is a member of the following committees relating to Risk Management of Medical Devices; ISO TC 210 – Medical Devices Technical Committee and CEN/ISO JWG1 – Joint Working Group on Risk Management.

One of John’s greatest achievements, in recent years, has been the development of the MDSAP and MDSAP Internal Auditor courses in response to demand from SQT’s loyal client base.

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 personalised 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 
• Technical Writing Skills 

These pathways build on the foundational knowledge gained to further strengthen capability in validation and compliance.