Data Integrity Principles :
Data Integrity as per United states Foods & Drugs Administration (USFDA) :
Data integrity refers to the completeness, consistency, and accuracy of data. Complete,consistent and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy and accurate (ALCOA).
Data Integrity as per Medicines and Healthcare products Regulatory Agency (MHRA) :
Data integrity is defined as ”the extent to which all data are complete, consistent and accurate throughout the data lifecycle”.
What is Meaning by Data Life Cycle :
All phases in the life of the data (including raw data) from initial generation and recording through processing, use, data retention, archive/retrieval and destruction.
Basic Requirement of Data Integrity :
- Every employee shall be responsible for ensuring data integrity and GXP practices in area of operation. GXP meaning Good “X” Practices used as Manufacturing/Documentation/Laboratory/Distribution.
- Every employee shall ensure that generated data is complete,
consistent and accurate in all its form i.e manual (paper) and electronic data.
- Data governance shall clarify data ownership and accountability throughout the lifecycle where design, operation and monitoring of processes/system shall be considered in order to comply with the principles of data integrity.
- Data governance shall include staff training in the importance of data integrity principles & the creation of a working environment that encourages an open reporting culture for errors, omissions & undesirable results
Data Governance :
The sum total of arrangements to ensure that data, irrespective of the format in which it is generated, is recorded, processed, retained and used to ensure a complete, consistent and accurate record throughout the life cycle.
16 thoughts on “Data Integrity Principles ALCOA & ALCOA PLUS in Pharma”
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