ICH E6 GCP Revision 3 – A First Look Into Updated GCP Principles

By Dr. Ulrich Köllisch
on April 26, 2021

Introduction

The ICH E6 Good Clinical Practice Guideline is a cornerstone in today’s guidance for Good Clinical Practice (GCP). The guidance addresses an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. With the goal to provide a unified standard for all ICH regions to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. As of March 2021, the newest revision R3 is in a draft state, so we took the opportunity to run down the important aspects of Data Integrity and Data Governance inside the first iteration of the ICH E6 GCP principles.

Upcoming Webinar - UNBLOCK Your Life Science Initiatives with Blockchain

By Vinicius Tarantino
on April 09, 2021

Our last Webinar about data integrity was a great success, and we thank you all for the questions and participation. We believe we can bring value to the industry when we collaborate to give insights and share solutions to our customers' challenges within compliance in Life Science.

10 CAPA Tips for the Medical Device Industry

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.

BLOCKCHAIN: From Cryptocurrency to Life Science

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).

What If We Could Prevent Another Damaging Pandemic Together?

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? 

A Look-back on Data Integrity in 2020 – Part 2

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. 

A Look-back on Data Integrity in 2020 - Part 1

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). 

Breaking Down Big Data in Life Science

By Roberto Orlandini
on August 31, 2020

In these times, when everything and everyone is connected to the internet, a large volume of data is generated daily. The good news is, the more information we have, the more chances we have to achieve goals that require that large amount of data and knowledge.

This is why data collection is so important for companies.

Key Characteristics of FDA Part 11 Compliance

Properly managing sensitive information to maintain privacy and security has become paramount in recent years. Today, pharmaceutical companies and medical device manufacturers are increasingly using the Internet to broaden their services making compliance with FDA regulation even more important.