12 lines
954 B
Plaintext
12 lines
954 B
Plaintext
WHAT ARE PQ (PERFORMANCE QUALIFICATION) TEST SCRIPTS?
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PQ test scripts (sometimes referred to as user acceptance testing) demonstrate the overall intended use of
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the system according to your procedures and processes.
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They are derived from the User Requirements Specification and should reflect the day-to-day or
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end-to-end use of the system in your environment.
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PQ test scripts are executed in an environment that simulates your production environment.
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PQ testing also verifies that the LIMS, ELN, or CDS is fit for its intended purpose,
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operates in accordance with defined standard operating procedures, performs according to the user requirements,
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and complies with 21 CFR Part 11.
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This testing will also look at the support environment within which the system is to operate,
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for example training or maintenance. Vendors do not often provide PQ test scripts or associated documentation,
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as it is based on your intended use, processes, and procedures. |