Annex 11: Progress in EU Computer Systems Guidelines - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Annex 11: Progress in EU Computer Systems Guidelines

Pharmaceutical Technology Europe
Volume 23, Issue 6

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 1987


I would like to express my gratitude to Ludwig Huber, Siegfried Schmitt, David Stokes, Sin 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.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology Europe,
Click here