Laboratory Software Validation

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.

• 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.

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.

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  Carmel McCrea Kelly

  Carmel McCrea Kelly, BSc in Quality Management & Technology...

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  John Lafferty

  John Lafferty, B. Tech. in Manufacturing Technology, Six Sigma ...

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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.