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    Poster Data Integrity

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    Sebastian Lopez
    Data integrity principles aim to ensure that data is attributable, legible, contemporaneous, original, accurate and complete according to the ALCOA and ALCOA+ standards. These principles were developed by regulatory agencies to help laboratories and companies properly implement data integrity practices and handle electronic records. The 9 key points cover making sure data is attributable, legible, contemporaneous, original, accurate and complete, consistent, enduring, and available.

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    Poster Data Integrity

    Uploaded by

    Sebastian Lopez
    251 views1 page
    Data integrity principles aim to ensure that data is attributable, legible, contemporaneous, original, accurate and complete according to the ALCOA and ALCOA+ standards. These principles were developed by regulatory agencies to help laboratories and companies properly implement data integrity practices and handle electronic records. The 9 key points cover making sure data is attributable, legible, contemporaneous, original, accurate and complete, consistent, enduring, and available.

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    Data integrity principles aim to ensure that data is attributable, legible, contemporaneous, original, accurate and complete according to the ALCOA and ALCOA+ standards. These principles were developed by regulatory agencies to help laboratories and companies properly implement data integrity practices and handle electronic records. The 9 key points cover making sure data is attributable, legible, contemporaneous, original, accurate and complete, consistent, enduring, and available.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    251 views1 page

    Poster Data Integrity

    Uploaded by

    Sebastian Lopez
    Data integrity principles aim to ensure that data is attributable, legible, contemporaneous, original, accurate and complete according to the ALCOA and ALCOA+ standards. These principles were developed by regulatory agencies to help laboratories and companies properly implement data integrity practices and handle electronic records. The 9 key points cover making sure data is attributable, legible, contemporaneous, original, accurate and complete, consistent, enduring, and available.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    Data Integrity

    The 9 Points to Ensure It


    Based on the acronyms ALCOA and ALCOA+, data must be attributable, legible, contemporaneous,
    original, accurate + complete, consistent, enduring and available (U.S. Food & Drug Administrati-
    on and the European Medicines Agency). ALCOA was developed to help laboratories, universities
    and companies implement data integrity. ALCOA+ principles were added to help responsible per-
    sons including executives, administrators and lab technicians handle data more easily and meet
    challenges related to electronic records.

    01 Attributable

    Record who performed an action


    and when.

    Complete 06
    All data, including any test, repetition or
    reanalysis performed. Data (records) must
    be complete.

    02 Legible

    Data must be readable throughout the


    entire lifecycle of the record.

    Consistent 07
    All components of the analysis, such as the
    sequence of events followed, are date- and
    time-stamped in the expected sequence.

    03 Contemporaneous
    Documented at the time of the activity.

    Enduring 08
    A sustainable record (systematically docu-
    mented) in laboratory notebooks or validated

    04
    systems.
    Original
    Original record or a certified copy.

    Available 09
    Can be accessed for review, audit or
    inspection over the lifetime of the record.

    05 Accurate
    No errors or editing without documented
    amendments. Reliable data.

    www.mt.com/lab-data-integrity
    30417794

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