Laboratory Software Validation

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Our fully interactive Laboratory Software Validation course provides attendees with the knowledge and skills they need to comply with European, US and Worldwide software validation requirements. The course is fully tutor-led and focuses on the practi... Read More

Our fully interactive Laboratory Software Validation course provides attendees with the knowledge and skills they need to comply with European, US and Worldwide software validation requirements. The course is fully tutor-led and focuses on the practical implementation of software validation requirements, providing attendees with a well-thought-out approach and real-world implementation methodologies to help achieve compliance and assure consistency of performance of computerised systems. This course covers the validation of standalone software such as LIMS systems, statistical packages and databases as well software contained in laboratory equipment ranging in complexity from centrifuges to integrated HLPC systems.

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. The course involves practical group exercises which take the learner through the entire validation cycle with comprehensive feedback from the course tutor throughout.

For abbreviations used in this brochure, see end of brochure.


What's covered?

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Day 1

  • The Need for Software Validation in the Laboratory
  • European and FDA Regulations and Guidance on Laboratory Software Validation
  • The latest FDA Guidance on Software Validation New
  • Group Discussion the latest FDA Guidance on Software Validation New
  • The GAMP Approach to Software Validation
  • The V Model ApproachV Model Approach interactive exercise
  • Software Validation Planning - designing Master Validation Plans
  • 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

Day 2

  • Case Study writing an equipment IQ Protocol
  • Software Testing and Software Test Environments
  • Software Testing Interactive Exercise
  • Case Study writing an equipment OQ Protocol
  • 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

Who should participate?

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  • Laboratory Managers, Supervisors and Technicians who wish to increase their understanding of Laboratory Systems and Software Validation
  • Laboratory Staff who will be involved in the validation of laboratory systems, equipment and software.
  • IT personnel who will be involved in laboratory software valid

What will I learn?

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Upon completion of this course, participants will be able to;

  • Identify the regulatory requirements for Laboratory Software Validation
  • Categorise software in accordance with GAMP guidelines
  • Apply the V Model to Laboratory Software Validation
  • Appreciate European and FDA Guidance publications on Software Validation
  • Design a software Validation Master Plan
  • Write User Requirements for software and computerised systems
  • Assess software and computerised systems risks
  • Identify the main requirements for Electronic Records and Electronic Signatures
  • Apply the FDA Guidance on 21 CFR Part 11 to software systems
  • State the main Data Integrity requirements,
  • Complete a software DQ
  • Write IQ test cases for computerised systems
  • Identify challenge tests for software systems
  • Write Software OQ test cases
  • Write Software PQ test cases
  • Leverage vendor documentation to minimise validation effort
  • Report on Software testing results
  • Assist in ensuring that the validated state is maintained

Who are the tutors?

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How do we train and support you?

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In-House Courses
Course tutor will contact your organisation in advance. In-house courses can be customised to meet your organisation’s specific requirements. Where appropriate, course exercises can be carried out using procedures, data etc from your organisation.

Course Manual
Delegates will receive a very comprehensive course manual.

Acronyms used in this document.

CFR Code of Federal Regulation (US Federal Law)
EU European Union
FDA Food and Drugs Administration
FDS Functional Design Specification
GAMP Good Automated Manufacturing Practice (Industry Guidance)
GLP Good Laboratory Practice
GMP Good Manufacturing Practice
IQ Installation Qualification
LIMS Laboratory Information Management Systems
OQ Operational Qualification
PQ Performance Qualification
URS User Requirements Specification
MVP Master Validation Plan

Share this Programme


Course Code
2 training days
Public Price
Virtual Training: €695

(includes course documentation)

Delivery Mode
This programme is delivered by Virtual Training, or In-Company training
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What Our Learner's SayWhat Our Learner's Say

Great course helps me undrrstand better the concept of csv for software
Brian W February 12, 2024
The course was very professionally run by a knowledgeable an engaging instructor. I would recommend to others to take the course. Depending on level of experience some people will get more out of it than others.
John M February 8, 2024

Laboratory Software Validation


Laboratory Software Validation

Duration: 2 days
Virtual Training: €695