Introduction:
Data governance and data integrity (DI) are important elements in ensuring the reliability of data and information obtained in the production and control of pharmaceutical products. The data and information should be complete as well as being attributable, legible, contemporaneous, original and accurate, commonly referred to as meeting “ALCOA” principles.
In recent years, the number of observations made regarding the integrity of data, documentation and record management practices during inspections of good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP) has been increasing.
Possible causes for this
may include
(i)
too much reliance on human practices;
(ii)
the use of computerized systems that are not appropriately
managed and validated;
(iii)
failure to adequately review and manage original data and
records.
What is Data Integrity?
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).
