QFINITY · Updates
The latest from QFINITY and the field.
An overview of updates beyond events and projects: articles and publications, work in industry bodies and committees, awards, and our perspective on new regulations.
At a glance
An overview of updates beyond events and projects: articles and publications, work in industry bodies and committees, awards, and our perspective on new regulations.
QFINITY’s CEO at the 30th anniversary of ISPE D/A/CH
Our CEO Oliver Herrmann was at the 30th anniversary of ISPE D/A/CH.
A total of 165 registered members celebrated the 30th anniversary of ISPE D/A/CH last week at the Annual General Meeting in Leverkusen. The motto of the event was “Shape the pharma world of tomorrow” and participants were treated to a two-day program full of expert presentations on current trend topics.
Oliver Herrmann also gave a presentation at the event.
We are delighted that Oliver Herrmann was able to take part in this event.
You can see more from the event here.
If you would like to read more news from QFINITY, click here.
If you have any questions, please contact us via our contact form.
article in the ISPE magazine
QFINITY’s CEO Oliver Herrmann, COO Marcus Schwabedissen and Sr. Exc. Consultant Frank Henrichmann have published an article in the official ISPE magazine.
Due to the increasing digitalization of the industry, we are highly dependent on IT systems and data. Cyberattacks have been on the rise for many years. Ransomware and phishing are the biggest threats to our industry. Unfortunately, people tend to think that disasters “only happen to other people”. As a result, they don’t pay enough attention to disaster recovery and business continuity planning. When an organization is hit by a ransomware attack, the value of pre-planning and preparation becomes clear, enabling an efficient recovery.
The article examines a hypothetical case of a successful ransomware attack. It outlines what recovery activities are required. The article also highlights the problems that arise from inadequate disaster recovery planning. And it examines potential challenges for the quality organization, such as root cause analysis, documenting recovery activities, risk management, assessing data integrity during recovery, and evaluating short-term workarounds.
We are pleased to have published another article in the official ISPE magazine.
You can find the article at ISPE.
You can find further news from QFINITY on our News page.
Read the article at Pharmaceutical Engineering (ispe.org)↗
Report 16th GAMP D-A-CH Conference
At the 16th GAMP D-A-CH conference, QFINITY was represented by CEO Oliver Herrmann, COO Marcus Schwabedissen, and Sr. Executive Consultant Frank Henrichmann – with a panel on innovation, digital transformation, and GxP, plus a talk on recovery after a cyber disaster.
QFINITY’s CEO Oliver Herrmann, COO Marcus Schwabedissen, and Sr. Executive Consultant Frank Henrichmann were at the 16th GAMP D-A-CH Conference.
Innovation, Digital Transformation and GxP
Our CEO Oliver Herrmann and Bernhard Appel led a panel discussion on “Innovation, Digital Transformation and GxP – now more than ever!”. They noted that companies today face the challenge of driving innovation and digitalization while also having to adhere to strict regulations and compliance requirements. The discussion centered on whether innovation and compliance can be combined. They emphasized that it is entirely possible to achieve both without jeopardizing patient safety or product quality. Quality Management & Compliance plays a crucial role here, as it ensures that processes run at the highest level without compromising safety.
On Dec. 7th, 2023, at the 3. GAMP Konferenz GxP in der Cloud in Mannheim, Frank Henrichmann presented practical aspects of recovering from a disaster. This is a hot topic: current data clearly show it is only a matter of time until a company is hit by a cyberattack. He used a ransomware attack on a cloud service provider as a hypothetical case study to highlight the potential challenges in the recovery process. He showed that good planning before the attack happens is key to a successful and timely recovery. But even the best plans need to be adapted to the actual scenario once disaster strikes. He focused on the challenges and questions that quality functions need to address and support to ensure the validated state of the applications and the integrity of the recovered data in the pharmaceutical industry.
Sustainability and GxP
Marcus Schwabedissen (QFINITY) and Steffen Ruttscheidt (d-fine GmbH) moderated the panel discussion on “Sustainability and GxP”. It offered insight into the growing importance of sustainability in the life science industry (GxP) and its impact on the sector. They showed that the Corporate Sustainability Reporting Directive (CSRD) plays a crucial role here. The CSRD will require companies to produce more detailed sustainability reports, promoting greater transparency and accountability around environmental impact and social responsibility. Companies in GxP-regulated industries will feel this too, as they will also have to implement sustainable practices.
QFINITY is proud to have participated in this year’s GAMP Conference. You can find further information about the conference at ISPE. For more information on events with QFINITY, please visit our website.