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.
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...
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...
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...
In Life Sciences, quality management systems are essential for ensuring the safety and efficacy of products. However, having a robust quality management system is only one part of the equation. To promote a culture of quality far beyond mere complian...
What Is a Non-Conformance Report? A non-conformance report is a document that explains a deviation from the anticipated outcome of a process or product. Some examples of events in the Life Sciences that may call for a non-conformance report are:
As the life sciences are digitalizing at an unprecedented scale and rate, data lifecycle management is becoming increasingly important. The two major factors driving this rapid and close-to-universal digitalization are Industry 4.0 and the COVID-19 p...
As forward-thinker management guru, Peter Drucker, once famously stated, “If you don’t measure it, then you can’t improve it.” After all, how will you know if something is better without comparison? Therefore, if you want to track your company’s stra...
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