More articles from Rucha Deshpande
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...
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...
Nobody knows the importance of 'Quality Records Management' better than a quality assurance professional! Quality records are invariably scrutinized in every internal or external audit. These documents are treated as living evidence of organizational...
Are you worried about writing a change control document for organization-wide change? It’s normal that this can feel like a gut-wrenching process sometimes. After all, change management is no easy task! The bigger the organization, the more arduous t...
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...
Defining Medical 3D Printing Simply put, 3D medical printing is the process of creating medical devices, transplants, surgical tools, and other medical products from a digital 3D model through additive manufacturing.
Rigorous quality management is fundamental in all regulated sectors, including pharmaceutical, biotech and medical device industries. A good Quality Management System (QMS) is able to define and organize documents and other processes in a quality-adh...
What Is Lean Six Sigma? Lean Six Sigma is a collaborative team effort to improve performance by systematically removing waste and reducing variation. The methodology has gained worldwide acceptance as a framework for continuous improvement.
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...
Everyone knows Aristotle’s famous quote “Well begun is half done”, but it is seldom true when it comes to sustaining organizational change initiatives for achieving better quality and excellence. Understandably, change is uncomfortable for most of us...
What is Kaizen? Kaizen is a Japanese term derived from two separate Japanese words, 'Kai' and 'Zen.' The word 'Kai' means change, and 'Zen' means good. Therefore Kaizen literally means 'changing for the good.' Kaizen is a widely accepted philosophy f...
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