Dale
Curtis Jr. is the President of Astrix Technology Group has written a review of
data integrity requirements for the laboratory. Here is an extract:
“Data
integrity is the maintenance and assurance of the accuracy and consistency of
data over its entire life-cycle. With regards to pharmaceutical manufacturing,
the FDA expects that all data submitted to the agency in an effort to gain drug
approval is complete, consistent and accurate. Data integrity is a fundamental
principle in pharmaceutical manufacturing that enables traceability of a batch
back to its origin and thereby ensures that drugs are made and tested according
to required quality standards.”
Posted by Dr. Tim Sandle
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