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Dr. Thaleia Papadopoulou
By Dr. Thaleia Papadopoulou
on October 13, 2021

In this 2nd part of the article series, we discuss the main outcomes in respect to eSource and EHRs in context with current regulations and expert views.

Dr. Thaleia Papadopoulou
By Dr. Thaleia Papadopoulou
on September 27, 2021

Global collaboration between regulatory agencies and health authorities became of paramount importance during the COVID-19 pandemic. Not only allowed it regulators to continue their inspections and surveillance function, but the cooperation also enabled the rapid development and approval of treatments and vaccines against the coronavirus SARS-CoV-2.

Dr. Ulrich Köllisch
By Dr. Ulrich Köllisch
on August 27, 2021

FDA recently published its quality report for FY 2020 which presents us a very interesting collection of observations, trends, and programs. Read more about it here.

Thomas Cullum
By Thomas Cullum
on August 02, 2021

Let's discuss in this article the potential use of statistical analysis to accomplish a computer system validation.

James Francum
By James Francum
on July 21, 2021

Regulatory bodies like the FDA enact initiatives on a routine basis. While their timing may seem random, such actions are usually driven by logic; most are taken in response to some noteworthy concern.

Gabriel Sena
By Gabriel Sena
on June 30, 2021

The world is getting connected more than ever. 

We know that  COVID  pushed the digital transformation and the cloud solutions, in combination with the broad access of the Internet, turning data consumption economically capable and available, creating an exceptional volume of data nowadays. 

James Francum
By James Francum
on June 11, 2021

The Quality Systems (QS) Regulations of FDA 21 CFR 820 are general standards that apply to finished devices, that are intended for human use. Rather than impose strict requirements, the regulations offer an opportunity to the manufacturers of these devices to incorporate their quality management standards into key organizational processes.

By Julian Oberle
on June 02, 2021

Let’s start this piece with a question for ourselves: do we still need password expiration as a security measure? In today’s life science industry, especially the pharmaceutical sector, a number of compliance reasons, guidelines, and agency regulations are responsible for an organization’s requirement to have their employees change their passwords every so often. It is now fair to say that we arrived at a point in time where most of the reasons behind the password expiration policy seem obsolete. 

James Francum
By James Francum
on May 19, 2021

According to a report from the US Food and Drug Administration (FDA), major deficiency letters were issued to 67% of premarket approval applications. Such deficiencies in applications can hold up premarket approvals - sometimes more than 180 days.

James Francum
By James Francum
on May 03, 2021

You have received one of the dreaded FDA Warning Letters. The last thing you want is to delay the launch of your company's latest innovation. However, you cannot risk shutdown for non-compliance and the possibility of never making it to market with your latest brainchild. 

Dr. Ulrich Köllisch
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.

Vinicius Tarantino
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.

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). 

Roberto Orlandini
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.

By Henry Macartney
on July 08, 2020

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.

By Henry Macartney
on June 30, 2020

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).

By Henry Macartney
on June 23, 2020

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.

Dr Zuhdi Hussein
By Dr Zuhdi Hussein
on June 12, 2020

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.

By Julian Oberle
on June 02, 2020

Computer Software Assurance (CSA)

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.

By Álvaro Spindola
on May 04, 2020

Ditital Transformation

Currently, digital transformation is a hot buzzword, and it’s something that everyone wants to be a part of, even if they don't understand what it is or what it means. So, what is digital transformation really?

By Julian Oberle
on April 03, 2020

ISO-9001-QMSTo stay competitive, every organization should consider what they can do to improve the quality of their products and services. In fact, having a clear understanding of your overall quality management system to ensure that you meet or exceed your customer’s expectations is a compelling way to improve your business.

That’s where the ISO 9001 Quality Management System (QMS) comes in.

The ISO 9001 is an internationally-recognized QMS standard that can benefit every organization or company. As a powerful business improvement tool, the ISO 9001 standard sets forth a strong QMS framework that produces many benefits for businesses.

By Henry Macartney
on April 02, 2015

Data IntegrityIs cybersecurity something you consider when designing a new product? As medical devices become more and more interconnected, the data they generate, store and share becomes more exposed.

James Francum
By James Francum
on September 03, 2014

ICH Harmonization ProcessThe methodologies your firm employs in the creation of pharmaceuticals, medicines and similar products designed for human consumption are most likely unique. Even if you follow relatively common chemical or physical manufacturing procedures, for instance, you still have to make modifications that fit your specific product design standards.

James Francum
By James Francum
on August 14, 2014

Ink Color for Signing DocumentsNot sure which pen to use? Although it seems like an amusing topic, your choice of writing utensil actually does make a difference when you're dealing with FDA documentation.

Dr Zuhdi Hussein
By Dr Zuhdi Hussein
on July 15, 2014

Quality By DesignPharmaceutical firms that wish to create product lines and cater to consumers as reliably as possible must ensure that their products are of a consistently high enough quality to fulfill user needs. While certain post-production checks and assurances can aid in this area, many organizations find it far more helpful to institute quality by design standards (QbD).

James Francum
By James Francum
on June 10, 2014

Process ValidationHow do you know your life sciences firm is maintaining compliance? While FDA audits and warning letters are obvious indicators, GMP guidelines give you a number of less-stressful ways to determine how well your equipment and processes are performing their tasks and whether they'll continue to do so consistently.

By Henry Macartney
on June 02, 2014

Deviation ManagementYour firm will experience compliance failures from time to time. In the realm of complex GxP-regulated processes, like automated pharmaceutical manufacturing and medical device quality assurance, things can go wrong with little advance warning.

Dr Zuhdi Hussein
By Dr Zuhdi Hussein
on April 25, 2014

FDA Gap Analysis ComplianceWhen GxP firms take actions to maintain compliance with recommendations from the FDA and the EU, it's critical that they actually analyze the results after the fact. Failing to assess your compliance implementations effectively and on a periodic basis could result in a regulatory authority taking action against your company.

Dr Zuhdi Hussein
By Dr Zuhdi Hussein
on March 26, 2014

IT InfrastructureMedical device manufacturers and pharmaceutical companies use advanced IT tools to maintain sensitive business information, manufacture products and establish valid Quality Systems. In the past data integrity has been an important topic and is an increasingly important focus for FDA and EU regulators. The architectures employed by life sciences firms must be designed to facilitate consistent oversight and well-maintained compliance.

James Francum
By James Francum
on March 12, 2014

Pharmaceutical Production ComplianceThe most succinct answer to the question of what determines FDA compliance with GMP regulations of pharmaceutical production is adherence to 21 CFR Part 210 and 211. Anything less than complete adherence will render products as “adulterated” in the eyes of the FDA. Failure to comply could lead to disruptive regulatory action against a company.

James Francum
By James Francum
on March 10, 2014

FDA & EU Medical Device ComplianceThe European Medical Device Directive or 93/42/EEC regulates which medical devices may be sold in the European market, while 21 CFR 820 is an FDA Quality Systems Regulation is a document that helps manufacturers of medical devices establish and follow a quality system within their company / organization in order to ensure that their manufacturing processes and the resultant products consistently meet and fulfill their applicable requirements and specifications. The 21 CFR 820 (also known as the FDA’s Quality System Regulation (QSR)) determines the cGMP requirements for medical devices.