Validation and Qualifications

Validation is generally known as the combined efforts of four qualifications. Validation of a computer system may be divided in more manageable pieces called Qualifications. It is common to use three or four Qs, but any number of qualifications may be used as long as it has been defined what each qualification comprises. The description of how to divide the validation effort is made in the Validation Plan.

Note that there are several way to define what each qualification comprises. None are probably incorrect, and most are correct. The main thing is to define it, and stick to the definition. Preferably this shall be defined for the whole company in order to handle validation in a consistent way.

• DQ - Development Qualification

• IQ - Installation Qualification

• OQ - Operation Qualification

• PQ - Performance / Process Qualification

What is included in a qualification

Each qualification comprises

• Writing the qualification plan

• Approving the plan

• Testing

• Writing the qualification report based on the testing

• Approving the report

Qualification plan

Test plans

Each qualification plan shall have a test plan, written in a way that it is possible to see

• What shall be tested

• How it shall be tested

• Expected results for the testing

Qualification report

DQ

The development qualification is the combination of

• Your selection of system, based on the URS and the vendor selection

• The vendor's development of the system which you audit to make sure that you are satisfied

• Your implementation of the bought system

IQ

The installation qualification includes

• Hardware (client, server, network, and other hardware needed to make the system complete)

• Software (operating system, database, the IT system in question, and network)

OQ

The operation qualification is to see that the system works according to your URS. The OQ is done before the system is taken into real use.

PQ

Performance qualification testing includes checking that the workflow in the system works according to your workflow in the organization.

PQ may also include the ongoing activities is to make sure that the system will continue to work according to your needs in a controlled way. The PQ phase then includes everything from the system is taken into live use until it retires.

• SOPs

• Logs and other documentation that SOPs are followed

Want to know more?

Publications:

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

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

Segalstad: Can You Rely on Your Information Technology, Inside Laboratory Management, Vol. 1 No. 4 (May 1997) 16-17.

Segalstad: Kvalitetssikring av laboratorier - Ufullstendig uten validering av IT-systemer. (Quality assurance of laboratories - incomplete without validation of IT systems), Kjemi 8, 1997, 16-18.

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

Segalstad: Development Qualification: Selecting the right LIMS vendor, European Pharmaceutical Review, Vol. 5 Issue 4 (2000) 58-61 Also published in: American Pharmaceutical Review, Vol. 3, Issue 4 Winter 2000-2001 (84-87)

Segalstad: How to use and misuse a consultant, Scientific Computing LIMS Issue January 2003 (14-19) Segalstad: Testplans according to 21 CFR Part 11, International Validation Technology (in press, probably in fall 2003 issue)

Classes:

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