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EMX
has been validated for 21 CFR Part 11 and is
compliant with the FDA's regulations for storing electronic records
and regulations for electronic signatures:
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EMX has a built in Auditing Trail and Electronic
Signature option that keeps track of all changes made to Auditable
records.
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EMX has been validated and proven
effective.
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EMX integrates user friendly functionality providing
real time auditing results.
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"Our maintenance
and calibration tasks are managed much better through EMX,
my follow up time has been reduced so much, I am actually
getting real work done!"
-Evelyn Tubbs, Cardiac Sciences |
Get Validated and Save Time with EMX EMX
Validation Protocol Template
One Red X Software, Inc has developed validation
scripts for EMX to speed your company through the validation process.
Brief Description
on how items are Audited:
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Password is required before every audited
item is saved. |
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Reason for Change is required for every audited item
that is changed. |
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Every change is recorded in the Audit History. |
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