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  • Warning Letter: Electronic files not properly validated or maintained (ucm178453)

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    Ofni Systems

    During the FDA inspection it was discovered that electronic records are used to establish the firm?s Complaint Files, 21 CFR 820.198. However there is no documentation to establish that these electronic records meet the requirements of 21 CFR Part 11, Electronic Records; Electronic Signatures. The requirements of 21 CFR Part 11 are designed to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records.

    For example, review of your electronic complaint files reveals they have not been properly validated there is no ability to generate accurate and complete copies of records in human readable and electronic form, there is no protection of records] to enable their accurate and ready retrieval, access to your system has not been limited, as well as other significant deficiencies.

    We strongly encourage you to perform a thorough and complete evaluation of all your electronic records in accordance with 21 CFR Part 11 as well as any guidance generated by FDA to assure conformance to our requirements.

    View the original warning letter.


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