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.
More articles from Rucha Deshpande
A quality audit is an inseparable part of the life sciences business. This is because healthcare products can have desired as well as undesired effects on patients. Therefore, it is important to manufacture them by following the best practices in the...
In the era of Quality 4.0, cloud cybersecurity has become a crucial concern for businesses. Many companies are exploring the impact of switching from on-premise Quality Management Systems (QMS) to cloud-based QMS. It is important to understand the di...
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...
According to the U.S. Food and Drug Administration (FDA), data integrity is the completeness, consistency, and accuracy of data. The agency places a significant emphasis on data integrity in regulated industries such as pharmaceuticals, biotechnology...
An eQMS is a digitalized Quality Management System where you can create, store, retrieve, and archive all of your company’s quality-related documents. In the context of a life sciences company, an eQMS also automates compliance requirements under 21 ...
Root Cause Analysis (RCA) is a systematic process used to identify the underlying cause or causes that lead to a problem or incident, with the goal of preventing its recurrence in the future. It is a systematic approach employed in various industries...
When searching for an eQMS (Electronic Quality Management System or Enterprise Quality Management System), it is crucial to prioritize platforms that are purpose-built for meeting the Quality Management Systems (QMS) requirements in the life sciences...
In the fast-paced and highly regulated world of pharmaceuticals, ensuring the highest standards of quality is paramount. Pharmaceutical Quality Assurance (QA) leaders face a myriad of challenges in maintaining compliance, minimizing risks, and delive...
In May 2017, Life Science organizations were hit by one of the biggest cybersecurity incidents - the WannaCry ransomware attack. WannaCry spread rapidly across networks, encrypting files and demanding ransom payments in Bitcoin to decrypt them. The U...
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 ...
Quality management systems (QMS) refer to the set of policies, procedures, processes, and resources that a company or organization puts in place to ensure that their products or services consistently meet or exceed customer requirements and expectati...
Regulatory agencies demand life science companies to produce high-quality, affordable medicines without compromising quality in manufacturing. For this reason, well-defined quality assurance goals are key for making life science businesses successful...
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