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 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...
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...
Even an organization with stellar leadership and a solid core of employees experiences hiccups from time to time. Despite having assembled all the ingredients for a great organizational culture or a superior product, a company or department is not li...
Quality Assurance (QA) is an essential process in Life Sciences organizations, regardless of their size. It involves ensuring that products, services, and processes meet specific standards, and regulations, and meet the needs and expectations of cust...
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...
A robust laboratory quality management system is essential in medical research laboratories to ensure the integrity and reliability of the tests conducted. Implementing a laboratory quality management system can be an overwhelming task, but organizat...
In GxP-regulated sectors like pharma, biotech, and medtech, computerized systems play a key role in ensuring patient safety, data traceability, regulatory compliance, and integrity. Many regulations and guidelines have been developed to validate such...
Data Quality… it's not a Goal, it’s a Mindset! Despite investing huge amounts of money in setting up data collection and storage infrastructure, many companies are insight-starved, experience data leaks and are unable to formulate a Data Quality plan...
21 CFR Part 11 stands for Part 11 of Title 21 of the Code of Federal Regulations. The US FDA issued this final Part 11 regulation in March 1997, which became effective in August 1997. It governs the FDA regulations for electronic signatures and elect...
Quality control (QC) processes can be a significant bottleneck in the smooth functioning of a pharmaceutical manufacturing unit if a lot of material gets stacked into either incoming raw material or the quarantined area before it gets approved. The c...
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:
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