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Computer Validations 1

Computer systems validation ensures that computer systems used in regulated industries like healthcare accurately perform their intended functions. Validation must demonstrate accuracy, reliability, consistent intended performance, and the ability to identify invalid or altered records. Computer systems can include desktops, servers, process control systems, data acquisition systems, and associated software. They are integrated into operating environments that may involve product development, testing, manufacturing, information management, or data used for drug submissions. Computer system validation provides documented evidence that systems function as intended.

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30 views1 page

Computer Validations 1

Computer systems validation ensures that computer systems used in regulated industries like healthcare accurately perform their intended functions. Validation must demonstrate accuracy, reliability, consistent intended performance, and the ability to identify invalid or altered records. Computer systems can include desktops, servers, process control systems, data acquisition systems, and associated software. They are integrated into operating environments that may involve product development, testing, manufacturing, information management, or data used for drug submissions. Computer system validation provides documented evidence that systems function as intended.

Uploaded by

sapis18
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Chapter 2

Validation Overview
WHAT IS A COMPUTER SYSTEM?
The term computer system can define any of the following: desktop systems; client or
of the following: desktop systems; client or server systems; automated process control
and laboratory systems; host-based systems; data acquisition and analysis systems; and
all associated software. The associated software comprises application software or
firmware, system software, and computer system supporting documentation.
Regulatory guidance
Computer systems shall be validated. The computer validation must ensure
accuracy, reliability, consistent intended performance, and the ability to discern
invalid or altered records.
Department of Health and Human Services, Food and Drug Administration, 21
CFR Part 11, Electronic Records; Electronic Signatures, Federation Register 62
(54), 1343013466, March 20, 1997.
In the regulatory context, computer systems are integrated into the operating environment
(Figure 211). The operating environment may include the process or operation being
controlled or monitored by the computer system, the procedural controls, process-related
documentation, and the people. Computer systems performing regulated operations may
either control the quality of a product during its development, testing, manufacturing, and
handling processes; manage information business operations; manage data used to prove
the safety; efficacy and quality of the product and formulation; and provide data for drug
submissions.

WHAT IS A COMPUTER SYSTEMS VALIDATION?


The validation of computer systems performing regulated operations provides
1

R.R.Herr and M.L.Wyrick, A Globally Harmonized Glossary of Terms for Communicating


Computer Validation Key Practices, PDA Journal of Pharmaceutical Science and Technology,
March/April 1999.

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