Thursday 2 November 2017

What the FDA Guidance on Data Integrity Means for Your Lab

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.”

The paper can be found here: Data Integrity

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Posted by Dr. Tim Sandle

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