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
In quality management, we frequently hear two concepts thrown around; Quality by Design (QbD) and Six Sigma. These two terms are sometimes confused with each other or used interchangeably. So, what exactly are Quality by Design and Six Sigma, and are...
What is Lean Six Sigma? As the name suggests, Lean Six Sigma is a business management strategy that combines principles of Lean manufacturing and Six Sigma.
GxP-compliant Software as a Service (SaaS) term is becoming increasingly popular owing to its flexibility and ease of use. SaaS is a web-based service as it uses the internet to conveniently make software available for direct use to its clients. SaaS...
Lean Thinking is centered around building efficient manufacturing operations by defining value from the customer's viewpoint and continually improving how value is delivered by eliminating wasteful resources or resources that do not contribute to the...
Old habits die hard and a paper-based QMS system is that old habit that has more disadvantages than advantages. Whereas the new eQMS system holds the seeds for success in future regulatory audits. That is why the bad old habit of using a paper-based ...
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...
Medical devices on the market are under strict surveillance by governing bodies such as the FDA. As with all tech nowadays, the Medical Device industry is evolving at hyperspeed, and regulations need to constantly keep up to date in order to continue...
In the Life Science industry, the race is on to earn the prestigious ISO 13485 certification as soon as possible, since it prepares companies for the future EU MDR audit. If you're in the life science industry and after the ISO 13485 certification, t...
As they say, 'necessity is the mother of an invention,' precisely this is what we experienced in the year 2020. The year 2020 drove every healthcare company to become the most tech-savvy company that it could ever become. The changing times have set ...
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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