Rucha Deshpande
QA Consultant, Scilife
With 11+ years in pharmaceuticals, Rucha brings expertise in quality, excellence, and data intelligence to uphold top-notch standards in manufacturing and drive industry advancement through Quality by Design.
What is EU GMP Annex 11? EU GMP rules, also known as the ‘EudraLex rules’ govern the medicinal products in the European Union. The EU GMP rules are split into three different parts plus about 20 annexes. ‘The EU GMP Annex 11’ is one of the supplement...
21 CFR Part 11 stands for Part 11 of Title 21 of the Code of Federal Regulations. The US FDA issued this final Part 11 regulation in March 1997, which became effective in August 1997. It governs the FDA regulations for electronic signatures and elect...
Data integrity of privacy? European Union's life science manufacturers that export pharmaceutical or medical device products to the United States are required to comply with GDPR and 21 CFR Part 11 compliance at the same time. The statutory requireme...
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