Data Integrity Principles ALCOA & ALCOA PLUS in Pharma

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 :

  1. 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.
  2. Every employee shall ensure that generated data is complete,
    consistent and accurate in all its form i.e manual (paper) and electronic data.
  3. 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.
  4. 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.

Data Integrity Principles ALCOA & ALCOA PLUS (CCEA)

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