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Is ezFreezer compliant with FDA Guidelines, including 21 CFR part 11? |
Yes, ezFreezer meets GLP and FDA Guidelines, including 21 CFR part 11 requirements.
Installation of the ezFreezer software alone will not ensure compliance with the rule. Your organization must also establish a range of policies and standard operating procedures that complement the facilities provided by the software.
Please visit http://www.fda.gov/ora/compliance_ref/part11 for more information.
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