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Data Integrity

The document discusses principles for ensuring data quality including making data attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available, and traceable. Data should include metadata about its origin and system to ensure it is attributable. Changes to data should be reversible to maintain legibility. Data should represent observations at the time they were made and include accurate date/time information. Processes are needed to ensure consistency throughout the data lifecycle. Data should be preserved and accessible according to retention requirements.

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35 views4 pages

Data Integrity

The document discusses principles for ensuring data quality including making data attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available, and traceable. Data should include metadata about its origin and system to ensure it is attributable. Changes to data should be reversible to maintain legibility. Data should represent observations at the time they were made and include accurate date/time information. Processes are needed to ensure consistency throughout the data lifecycle. Data should be preserved and accessible according to retention requirements.

Uploaded by

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

Data should be attributable to the person and/or system generating the data. Based on
the criticality of the data, it should also be traceable to the system/device, in which the
data were generated /captured. The information about originator (e.g. system operator,
data originator) and system. (e.g. device, process) should be kept as part of the
metadata.

www.valsquare.in
Legible
Data should be maintained in a readable form to allow review in its original context.
Therefore, changes to data, such as compression, encryption and coding should be
completely reversible.

Contemporaneous
Data should be generated by a system or captured by a person at the time of the
observation. The time point of the observation and the time point of the storage should
be kept as part of the metadata, including the audit trail. Accurate date and time
information should be automatically captured and should be linked and set by an
external standard.

Original
Data should be the original first generation/capture of the observation. Certified copies
can replace original data (see section 6.5. on certified copies). Information that is
originally captured in a dynamic state should remain available in that state.

Accurate
The use of computerised systems should ensure that the data are at least as accurate
as those recorded on paper. The coding process, which consists in matching text or
data collected on the data acquisition tools to terms in a standard dictionary, thesaurus,
or tables (e.g. units, scales), should be controlled. The process of data transfer between
systems should be validated to ensure the data remain accurate.
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Data should be an accurate representation of the observations made. Metadata should
contain information to describe the observations and, where appropriate, it could also
contain information to confirm its accuracy.

Complete
To reconstruct and fully understand an event, data should be a complete
representation of the observation made. This includes the associated metadata and
audit trail and may require preserving the original context.

Consistent
Processes should be in place to ensure consistency of the definition,
generation/capturing and management (including migration) of data throughout the
data life cycle. Processes should be implemented to detect and/or avoid contradictions,
e.g. by the use of standardisation, data validation and appropriate training.

Enduring
Data should be maintained appropriately such that they remain intact and durable
through the entire data life cycle, as appropriate, according to regulatory retention
requirements.

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Available
Data should be stored throughout the data life cycle and should be readily available for
review when needed.

Traceable
Data should be traceable throughout the data life cycle. Any changes to the data, to the
context/metadata should be traceable, should not obscure the original information and
should be explained, if necessary. Changes should be documented as part of the
metadata (e.g. audit trail).

ValSquare Consultancy Services Pvt Ltd


Computer System Validation & IT Regulatory Compliance Services

Contact us: +91- 9390056495, info@valsquare.in


Hyderabad, Telangana, INDIA

www.valsquare.in

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