Which requirements exist?

Various industries have their own sets of requirements that they comply with. Some of them are mandatory for the industry, while others are voluntary.

Pharmaceutical industry

The pharmaceutical industry has several national and international sets of mandatory requirements. They include requirements for the IT systems to various degrees.

The sets are known as the GxPs, and comprise of

• GMP - Good Manufacturing Practice for manufacturing and the quality testing of the manufactured goods.

• GLP - Good Laboratory Practice for non-clinical testing.

• GCP - Good Clinical Testing for the clinical testing of the products

Additionally, there is GAMP, which is a great tool for anyone planning to buy, implement, validate and use any computer system in any industry.

Companies that sell their products to the US also need to be in compliance with the US FDA 21 CFR Part 11.

Companies that sell their products to the EU also needs to comply with the regulations created by the PIC/S. This is equivalent to the 21 CFR Part 11.

Hospital industry

The hospital industry in the US has requirements set forth by the Joint Commission for Hospital Accreditation. Other countries may also have requirements.

Environmental labs

Environmental labs in the US shall comply with EPA's Good Automated Laboratory Practice (GALP).

In Europe it is more common to use ISO standards ISO 17025. This has replaced older standards like ISO 45001 and ISO Guide 25.

Certification and accreditation

All types of labs may be certified or accredited to certain standards. In Europe ISO / EN is commonly used. Accredited testing and calibration laboratories use ISO 17025. This also has a guidance document for how to handle the IT systems in the lab.

Want to know more?

Web sites:

Publications:

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

Segalstad: The WWW (Who-Why-What) of 21 CFR Part 11 Electronic Records and Electronic Signatures, European Pharmaceutical Review Vol. 5 Issue 2 (2000) 69-74.

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.