Laboratory Software Validation

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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... Read More

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.

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What's covered?

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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 attend?

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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 validation.

What will I learn?

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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?

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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.

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Duration
1 training day
Course Times
9.00am - 5.00pm
Price
£420

(includes course documentation, lunch and refreshments)

Delivery Mode
This programme is available In-House and on certain Public dates

What They SayWhat They Say

Very friendly tutor. Course moved at a comfortable pace.  Questions answered very quickly – tutor very knowledgable

– Conradh Reilly, QC Analyst, Ethicon Biosurgery Ireland

Laboratory Software Validation

Duration: 1 dayPublic Price: £420
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