PIC/S
has issued a new draft document relating to data integrity, titled “Good
practices for data management and integrity in regulated GMP/GDP environments.”
(PI 041-1 (Draft 2)).
According
to the document:
Data
Integrity is defined as “the extent to which all data are complete, consistent and
accurate, throughout the data lifecycle” and is fundamental in a pharmaceutical
quality system which ensures that medicines are of the required quality. Poor
data integrity practices and vulnerabilities undermine the quality of records
and evidence, and may ultimately undermine the quality of medicinal products.
Data
integrity applies to all elements of the Quality Management System and the principles
herein apply equally to data generated by electronic and paper-based systems.
Posted by Dr. Tim Sandle
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