8. Should, or the adjective "recommended", mean that in certain circumstances valid reasons may exist to ignore a particular
item, but the full implications must be understood and carefully weighed before choosing a different course.
9. Infrastructure - the hardware and software such as networking software and operation systems, which makes it possible for
the application to function. Annex 11.
10. Qualification - action of proving that any equipment works correctly and actually leads to the expected results. Eudralex
Volume IV, Glossary.
11. GAMP Guide For Validation of Automated Systems in Pharmaceutical Manufacture, Version V5.0, Good Automated Manufacturing
Practice (GAMP) Forum, International Society for Pharmaceutical Engineering, Tampa FL, 2008.
12. Validation - action of proving, in accordance with the principles of Good Manufacturing Practice, that any procedure,
process, equipment, material, activity or system actually leads to the expected results. Eudralex Volume IV, Glossary.
13. Process - set of interrelated or interacting activities that transform inputs into outputs. Note: Inputs to a process
are generally outputs of other processes. ISO 900, Quality Management Systems Requirements.
14. Critical data – can be defined as patient safety, data integrity and product quality related data.
15. Specification - document stating requirements. ISO 900, Quality Management Systems Requirements.
16. Establish means define, document (in writing or electronically), and implement.
17. Raw data - All data on which quality decisions are based should be defined as raw data. Eudralex Volume IV, Glossary.
18. Edits -- software may be written in such a manner as to reject or alter certain input or output information, which does
not conform to some pre-determined criterion or otherwise fall within certain pre-established limits. Edits can be a useful
way of minimizing errors and/or to reject erroneous entries. Edits can also be used to falsify information and give the erroneous
impression that a process is under control.
19. P. Hill, “An Introduction to computer system validation”, A Seminar held in Sydney, Australia from 18 to 20 September
1996. Inspection of Computer Systems published by the Secretariat to the PIC and PIC/S.
20. Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological
Health Food and Drug Administration, “Guideline on General Principles of Process Validation,” U.S. FDA, Rockville, MD, May
I would like to express my gratitude to Ludwig Huber, Siegfried Schmitt, David Stokes, Siôn Wayne and Siri H. Segalstad who
provided recommendations to improve this article.
The information contained in this article is provided in good faith and reflects the personal views of the author. These views
do not necessary reflect the perspective of the publisher of this article. No liability can be accepted in any way. The information
provided does not constitute legal advice.
This article is dedicated to my grandson, Mikhail Lopez…the Jr.