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Poster Data Integrity

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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Sebastian Lopez
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1K views1 page

Poster Data Integrity

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.

Uploaded by

Sebastian Lopez
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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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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