Avoid FDA warning letters by Fostering Data Accuracy


Companies involved in the life sciences industry, either in the pharmaceutical industry, food or other trades, are all fully aware of their responsibility to ensure data integrity at all times. We expect no argument here. So why is it that the FDA has issued seven warning letters to companies from various countries last year, followed by already two new cases in 2017? And why is it that most of our employees recently had to be assigned to various projects regarding computer system validation?

‘Overdue maintenance’

Apparently the FDA has touched a sore spot here and revealed some ‘overdue maintenance’. For us at Vivenics, this only proves yet again that we are not selling hot air with our daily efforts to optimize the processes for life science professionals. After all, there are better ways to promote your company, to put it mildly. With a background in R&D at Organon, which was taken over by Schering-Plough and Merck respectively, we know R&D processes like the back of our hands. By looking at things from an IT perspective, without actually supplying IT, we help companies in the pharmaceutical, food and other businesses in streamlining their R&D processes. As such we provide solutions in the field of lab productivity, data management and process optimization.

Audit trail

Having your current systems validated before implementation is one thing but it is equally important to keep them up to date and in accordance with all national and international regulations. This means that patches, regular updates and other pieces of software that are added later on all have to be validated as well. While in the process, Vivenics also takes care of the extensive documentation and risk analyses involved in providing the necessary evidence. As shop floor and lab equipment and the associated software are particularly susceptible to harming your data integrity, co-delivering an audit trail or log file by suppliers has become mandatory. As we feel an obligation to be accountable in our turn, we will explain more about some of the crucial principles that rule our world in the upcoming blogs.

Meanwhile, if you want to incorporate the FDA in your daily practice, just make sure it stands for Fostering Data Accuracy!