Joachim Nuyttens

August 30, 2021
regulations compliance

Audit trail requirements on GxP computerized systems

According to Wikipedia an audit trail is a chronological record providing documentary evidence of the sequence of activities that have affected at any time a specific operation, procedure, event, or device. The first uses of audit trails date back to ancient civilizations when rudimentary methods emerged to manage goods, soldiers and financial transactions. Audit trails to ensure data integrity came into the spotlight when US regulation 21CFR Part 11 was issued in 1997. Part 11 requires the use of secure, […]
May 28, 2021
office365 training

Tools to be efficient & effective

Yesterday our whole team joined in on a digital training, the second part of our program on “Efficiency & Effectiveness” organized by X-Conscious. We learned how to use tools such as Outlook, Onenote and Teams more efficiently. So that instead of these tools creating work, they start doing the work for us. Our trainer Bert Gielen explained us how to manage calendars and tasks, what good strategies are to manage our mailbox, how to effectively use Onenote for meeting reports […]
May 5, 2021
mobiliteitsbudget

About the mobility budget, from our colleague Rob

Our colleague Rob Hanusa is now in his second year using a mobility budget. We asked him how this is going, and how he organizes his commutes. How are you commuting? On the days I go to the office (which are fewer now because of Covid), I take the train and my folding bike. I’m fortunate to live near to a station, and once I get to my destination it’s an 8km bike ride to the office. Most of the […]
April 22, 2021
rocks and sand

Workshop efficiency & effectiveness

Today the whole team “zoomed in” on a digital workshop on “Efficiency & Effectiveness”. Nico Van de Venne was our coach. He gently guided us in discovering how we can organize our working days to be more efficient and less stressful. We learned what big rocks and sand can tell us about priorities. We learned how to make up a week planning providing time for the unexpected but especially for our non-work related activities. We learned how good Eisenhower was […]
March 14, 2021
Yannick Jonsson

Employee testimonial – Yannick Jönsson

In this testimonial our colleague Yannick tells us what it is like to work for Trevalco as a consultant. As a consultant, what are your main activities? Since I work at Trevalco I have executed multiple projects. As a CSV consultant it is my job to ensure correct testing and documentation when new software supporting pharmaceutical production is installed, existing software is updated or retired. On my current assignment, as an MBR project engineer I configure the electronic batch record […]
February 27, 2021
Team event: digital escape room

Digital escape room

2021’s new year event had to go digital, but nevertheless we had a great time with the whole team. First there was a business update by Tim, followed by introductions of new colleagues and some questions & answers. We skipped to the fun part of the evening after 30 minutes. All colleagues had received a food box delivered at their home by Cosmocafé. This was really delicious. For the vegetarians, like myself, there was a meat-free version. The fun part […]
February 20, 2021

Common FDA warning letter observations in 2020

Last year was a bizarre year and, hopefully, one of a kind. Not only did Covid-19 affect our personal and professional lives, it also had a huge impact on regulatory inspections which were delayed or executed remotely. In this article I present the main result of a data analysis on pharmaceutical FDA warning letters of 2020. I used the same tools as presented in one of my earlier articles on FDA warning letters. As shown on the pie chart below […]