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...
The pharmaceutical industry is one of the most rapidly evolving industries in the world, with new advancements and breakthroughs being made every day. Keeping up with the latest pharmaceutical industry news can be challenging, but fortunately, there ...
Even an organization with stellar leadership and a solid core of employees experiences hiccups from time to time. Despite having assembled all the ingredients for a great organizational culture or a superior product, a company or department is not li...
A robust laboratory quality management system is essential in medical research laboratories to ensure the integrity and reliability of the tests conducted. Implementing a laboratory quality management system can be an overwhelming task, but organizat...
The new year is a perfect time to plan for the conferences and events that will keep you in the loop for the latest and greatest in the pharma and biotech world. Here, we’ll look at some of the biggest events and most important conferences to attend ...
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...
Quality control (QC) processes can be a significant bottleneck in the smooth functioning of a pharmaceutical manufacturing unit if a lot of material gets stacked into either incoming raw material or the quarantined area before it gets approved. The c...
What Are ATMPs? ATMPs is an acronym for Advanced Therapy Medicinal Products. These medicinal products are based on genes, tissues, or cells. Research shows that ATMPs provide promising therapeutic applications for Alzheimer's disease, cancer, muscula...
For thousands of years, our ancestors have used the cannabis plant to treat illnesses. The medicinal use of the cannabis flower is made possible thanks to its hundreds of chemical compounds that create pleasant sensations, feelings of relief, and hea...
Most pharma and MedTech companies have had digital transformation on their to-do list for quite some time. Unfortunately, only a few (roughly 20%) have actually pivoted from doing digital to being digital.
Modern healthcare is being shaped by a marked rise in technology use—based on the next generation of personalized medical care. Science, to this end, is bolstering patient centricity, especially as data becomes increasingly available in the public do...
How Smart Can Smart Software Be? Smartphones, smart cars, smart cities, smartwatches, smart locks… and the latest addition to the list: Smart Quality Management Software! In today’s smart age, we are surrounded by many smart tools powered by cutting-...
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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