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...
In GxP-regulated sectors like pharma, biotech, and medtech, computerized systems play a key role in ensuring patient safety, data traceability, regulatory compliance, and integrity. Many regulations and guidelines have been developed to validate such...
GxP-compliance Software as a Service (SaaS) is becoming increasingly popular owing to its flexibility and ease of use.
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