European Commission revisions to GMP Chapter 4 align documentation expectations for electronic records and signatures with an updated Annex 11 emphasis on data integrity. Strengthened Annex 11 ...
Built-in data integrity is a bare minimum requirement in today’s BioPharmaceutical manufacturing. Good Manufacturing Practices (GMP) regulations of the Food and Drug Administration (FDA) highlight the ...
In mid-2009 The Nickerson Lab in the Department of Genome Sciences at the University of Washington faced the daunting task of rapidly scaling up their next generation sequencing laboratory. Given the ...
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