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.
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...
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...
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...
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...
Top 11 FAQs about GMP Guidelines for Quality Management Systems The GMP guidelines are mandatory in most countries for pharmaceuticals, medical devices, and food industries. Companies that fail to comply with these guidelines can face severe regulato...
Change is essential for growth, no matter which sector your company or organization excels in. However, change can also be a trying period in any company unless you and your team are well prepared for it. The best way to prepare yourself and your tea...
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...
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...
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...
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 ...
A Complaint Management System (CMS) is a software or procedural framework designed to efficiently handle and monitor customer complaints within a business. It facilitates the submission of complaints through various channels and tracks their progress...
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