Purpose

A validation plan is recommended for a larger IT project in the regulated industries. This is an overview of the planned validation activities for the project and the system. It is a smart thing to do, as it is often easy to loose the overview in all the single activities during the project period.

Content

Validation of a complete large system is complex. The goal is to break the task into smaller, manageable pieces. This is what is describes in the validation plan.

This could be done by defining stages in the project, or use the DQ-IQ-OQ-PQ approach. For each of the defined stages, define the assumptions and input to the stage, what shall be done during the stage, and the expected output of the stage. A list of the topics needed to be covered in the system SOPs shall be included, either in a stage or separately. Ideally this should be done before the system implementation, or at least as early as possible in the project.

Validation report

A natural follow-up to the validation plan is of course a report. This includes the identification and location of the documentation created during the project, which were listed in the plan.

Want to know more?

Publications:

Segalstad: Validation of computer databases for GxP. Chapter in book Good Research Practices, edited by Nigel Dent, Butterworth and Heineman (1996) 475-485.

Segalstad and SynnevDg: A practical guide to validating LIMS, Laboratory Information Management 26 (1994) 1-12 (Tutorial).

Segalstad: Software validation according to EU GMP Annex 11, European Pharmaceutical Review, Vol. 2 Issue 4, (1997) 55-64.

Segalstad: Quality Assurance of Computer Systems What is needed to comply with ISO 9000, GMP, GLP, and GCP?, Laboratory Automation and Information Management 31 (1995) 11-24.

Segalstad: Quality Assurance of Computer Systems Compliance with GMP, GLP, GCP and ISO Standards, LIMS Letter Vol II - Issue I, Spring 1996.

Segalstad: Instrument validation, Managing the Modern Laboratory Vol.5 No.3 2001 (57-61)

Classes:

Classes are occationally offered by Segalstad Consulting AS and the company's affiliates. They are open to whoever wants to attend. Classes may also be offered on request, tailored to needs for in-house training in your company.