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Articles and analysis from our own work across GxP, pharma, quality management, GAMP and AI - what is changing in the regulated environment, what it means in practice, and what is happening inside our company.
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ISPE Europe Annual Conference | April 2024
QFINITY is proud and honored to continue its volunteer contributions to organizing ISPE Conferences. QFINITY’s CEO, Oliver Herrmann and the Sr. Executive Consultant and current ISPE GAMP Global Steering Committee co-chair Frank Henrichmann are part of the planning committee for the ISPE EU annual Meeting 2024 in Lisbon.
While Oliver Herrmann is helping organize the Digital Transformation track, Frank Henrichmann supports the GAMP 5 Track for this exciting conference in April next year. The program will be packed with workshops and presentations from leading industry experts and regulators. Join us at this exciting event in 2024!
More information about the ISPE EU annual Meeting 2024 is available at: https://ispe.org/euac24
ACDM Annual Meeting | March 3-5, 2024
Marcus Schwabedissen, COO, and Frank Henrichmann, Senior Executive Consultant, from QFINITY will be at the ACDM Annual Meeting in Copenhagen from March 3rd to 5th.
We are very pleased that Frank Henrichmann will present “How to comply with EU Guideline on computerised systems and electronic data in clinical trials” at the conference. The EMA released this regulatory guideline in 2023. It is the most extensive and detailed guidance ever published specifically for GCP systems. The EMA guideline covers key definitions and principles like Source Data, Responsibilities, and Data Integrity, along with expectations for computerized systems and their validation, including vendor management. It also covers electronic data – from data capture to audit trail review and migration – together with security expectations.
His presentation will focus on the guideline’s key topics and the challenges of adopting it.
What were the regulators’ reasons and intentions in creating this guidance?
What are the most critical changes, and how can we address them?
The main focus will be the validation of computerized systems used in clinical trials at clinical sites. He will also cover expectations for vendor oversight and collaboration, especially when using Software-as-a-Service (SaaS), and the detailed expectations for data archiving and retention.
We look forward to meeting you there and discussing technology quality management topics with you.
For more information about the ACDM Annual Meeting, click here.
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)↗