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RE: Retrospective Validation of ...
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Title: RE: Retrospective Validation of
...
As to the Q's: Follow the guidance that the CDRH
has given to industry and inspectors in february: General Principles
of Software Validation; Final Guidance for Industry and FDA
Staff.
Quote:
3.1.3 IQ/OQ/PQ For many years, both FDA and regulated industry
have attempted to understand and define software validation within the
context of process validation terminology. For example, industry
documents and other FDA validation guidance sometimes describe user
site software validation in terms of installation qualification (IQ),
operational qualification (OQ) and performance qualification (PQ).
Definitions of these terms and additional information regarding
IQ/OQ/PQ may be found in FDA's Guideline on General Principles of
Process Validation, dated May 11, 1987, and in FDA's Glossary of
Computerized System and Software Development Terminology, dated August
1995.
While IQ/OQ/PQ terminology has served its purpose
well and is one of many legitimate ways to organize software
validation tasks at the user site, this terminology may not be well
understood among many software professionals, and it is not used
elsewhere in this document. However, both FDA personnel and device
manufacturers need to be aware of these differences in terminology as
they ask for and provide information regarding software
validation.
end quote.
To test a system, you will need to design tests
that prove that the system is suited for its intended use. Some are
unit tests, some integration tests, some system tests. You can have
"use case" and technical testing, black an white box
testing.
Testing can take place in many environments
(development, acceptance, operational, automated test system,
simulator, ...).
Important is to focus on what you intend to
prove. The complexity of conclusive evidence is such that the Q-model
does not at all permit to solve the validation for anything but
end-user/very small applications. Professional software development
processes are needed, and as stated by the FDA: the Q's are Chinese to
advanced software developers.
Paul Herremans
-----Original Message-----
From: Denny J. Walthers [mailto:dwalthrs@walthersassoc.com] Sent: Saturday, 27 April 2002 16:37 To: PharmWeb Computer Validation Subject: RE: Retrospective Validation of ... It is wonderful that the software is running so
well and that there
are no errors. However, ever hear of Edsel K. Murphy? It will happen. The basic difficulty from the very weak position that I occupy is that software used in medical devices and/or drug, med dev, biological manufacturing must be validated. That means User Requirements, System Specification, IQ, OQ, and the PQ is problematic. For my money, PQ's on software really do not accomplish anything because the software does not change. ALL OF THE TESTING should be done in the OQ. Also, refer to 21CFR Part 11 not just for
electronic signatures but
for the electronic records that must be kept as well. AUDIT TRAILS. Learn about them and put them into everything that you do.Some of us saw this coming years ago. I personally put audit trails into software I developed for the company that was working for as far back as 1983. It just makes good sense. Spend the time and do it right, you won't have to
do it over. That is
from someone who has learned from experience. Denny J. Walthers
dwalthrs@walthersassoc.com |
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