Laboratory Software Validation

Validation of equipment and methods is a vital element of assuring the integrity of results from laboratories in the pharmaceutical, healthcare and medical device industries. This course covers the life cycle for laboratory equipment validation, from requirements specification to installation, operation and performance testing. It addresses the requirements for the control of electronic records and signatures within a laboratory environment. The course is aimed at fulfilling the requirements of the latest industry requirements such as; EU GMP Vol 4 Annex 11, ISO 13485 and 21 CFR Parts 11, 211 and 820, and the GAMP guidelines. This course covers the validation of standalone software such as LIMS systems, statistical packages and databases as well software contained laboratory equipment ranging in complexity from centrifuges to integrated HLPC systems.

Delivery Mode

  • Public Virtual

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  • Customised

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What's covered?

Guidelines for Laboratory System Validation focusing on the current regulations from the FDA and European authorities in the area of GLP will be outlined.

The life cycle for laboratory equipment and software validation from specification to installation, validation and start up for a typical piece of lab equipment will be outlined.  The expected content of key documents such as URS, FDS, MVP, IQ, OQ and PQ as applied in the laboratory environment will be discussed. Course participants will gain hands-on experience of writing key elements of validation documents such as; requirements statements, risk assessments and validation test cases.

The course will also cover the ongoing control of both standalone and embedded software within the laboratory environment including requirements for; Security, Back-up, Data Integrity and Disaster Planning. The requirements for electronic records and electronic signatures and in particular the requirements of 21 CFR Part 11 will be outlined. Throughout the course the tutor will discuss ways in which the validation of equipment software and hardware can best be combined.

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

Who should participate?

  • 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 validation.

What will I learn?

Participants achieve the following learning outcomes from the programme;

  • Demonstrate a working knowledge of the fundamentals and principles of validation and how they are applied in a laboratory.
  • Generate key elements of validation documents such as URS, FDS, MVP, IQ, OQ and PQ.
  • Apply the requirements of 21 CFR Part 11 in the laboratory environment.
  • Apply ongoing controls to laboratory equipment and software.
  • Apply the above to both standalone software packages and on-board software embedded in laboratory equipment.

Who are the tutors?

Carmel McCrea Kelly

Carmel McCrea Kelly, BSc in Quality Management & Technology, Cert Manufacturing Engineering, Training & Continuing Education & Dip Pollution Assessment and Control is a Quality professional with over 20 years experience in the Medical Device and Pharmaceutical industry.

Carmel joined SQT as a tutor in 2018 and continues to work as a Quality Management Consultant with Northridge Quality and Validation.  Carmel feels that by combining her consultancy work with training through SQT she is best placed to impart her vast knowledge and experience to those currently working in the industry.  Prior to joining SQT, Carmel spent six years as Head of QA and RA of Medical Device Manufacturing plant where some of her achievements were; gaining certification to ISO 13485: 2016 and 21 CFR Part 820 and gaining CE Mark certification for several active Medical Devices.

Carmel has extensive experience of carrying out software validation projects in the industry over many years and continues to assist companies with these types of projects today.  Carmel regards achieving compliance with the EU Medical Devices Regulations (MDR) and maintaining adherence to the Software Validation requirements of ISO 13485: 2016 as being some of the biggest challenges facing Medial Device companies today.

John Lafferty

John Lafferty, B. Tech. in Manufacturing Technology, Six Sigma Black Belt, Cert. Training & Continuing Education, Cert. Quality Management, 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.

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

How do we train and support you?

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.

John Lafferty


John Lafferty

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