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Dr Zuhdi Hussein
By Dr Zuhdi Hussein
on March 31, 2021

The CAPA process from the side of regulatory compliance of both U.S. FDA requirements (21 CFR 820.100) and EU regulatory requirements (ISO 13485, 8.5.2) is one of the most important elements of a Quality Management System (QMS). 

It is essential to develop a system the right way to assure QMS effectiveness and minimize irregular findings on regulatory audits.

Roberto Orlandini
By Roberto Orlandini
on March 09, 2021

WHAT IS BLOCKCHAIN

Blockchain is the technology that created the 128 Bi cryptocurrency market, which is at the heart of Bitcoin and other virtual currencies such as Ethereum, Tether, and more. The Blockchain is an open, distributed ledger that can record transactions between two or more entities in an efficient, verifiable, and permanent way. The ledger itself can also be programmed to trigger transactions automatically (smart contracts).

Chong Yang Gue
By Chong Yang Gue
on February 16, 2021

Speed. It is the deciding factor between hundreds or millions of death cases. In a pandemic, speed is everything. The World Health Organization's (WHO) emergencies program executive director Michael Ryan, a doctor experienced in the Ebola outbreak, rightly said in a COVID-19 press conference that speed trumps everything else in an emergency response. Speed defines life or death. Governments, people, and especially the pharmaceutical sectors must embrace the speed to conquer a pandemic. Countries that are slower to respond are paying a huge price. Speed is everything that includes the pharmaceutical industry as well. What if we could make the vaccine available to the majority within one month instead of 18 months? 

Dr. Anjana Venkataramanan
By Dr. Anjana Venkataramanan
on February 08, 2021

This is part 2 of a 2-part article series on Data Integrity trends in 2020. Find the link to part-1 here. 

Dr. Anjana Venkataramanan
By Dr. Anjana Venkataramanan
on January 25, 2021

Data Integrity in 2020 

The year 2020 was a game-changer in many aspects. It has forever altered the way we perceive reality down to every facet of our lives and how we implement our everyday activities. This stands true even more in the healthcare world, which has undergone a tremendous shift in a span of 10 months on a global scale. The world of regulatory affairs and compliance has also undergone some changes that has affected our views on data and our attitude towards data governance and data integrity (DI).