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?
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).
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.
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.
Quality risk management implementation identifies and manages risks; under normal circumstances the risk-based approach to the validation of computerized systems should eliminate the risks to the system, or should at least reduce the risks to a tolerable level. (This tolerable level must naturally be defined prior to the execution of the risk analysis).
Are you sure your IT infrastructures are fully qualified, or is it possible that your methodologies missed some vital detail along the way? Perhaps you know you're good at maintaining infrastructure compliance, but your organization is about to reach its operational limits. Either way, it's time for a serious change.
Data integrity is an ever-increasing concern in life sciences, with medical device manufacturers feeling much of the conformity backlash. There continues to be heightened regulatory focus on diverse cybersecurity topics, including data integrity.
Companies that are regulated by the U.S. Food and Drug Administration (FDA) are required to perform validation to prove their software and systems are performing correctly. That’s why, with relatively few changes, we have been using Computer System Validation (CSV) for over 20 years in the regulated sector. The FDA’s first Principles of Software Validation, and later ISPE GAMP, continue to be the main go-to guidance and principles to help implement CSV.