What is really new about the topic
New, in particular, is the increasing complexity of state-of-the-art IT solutions and automation infrastructure! How can one be sure with the enormous amount of data from a wide range of organisations, technologies and processes that all is “ALCOA+”? During an audit, it is irrelevant whether data integrity violations are due to deliberate falsification, a mistake, or system failure. The application of the right tools and measures ensures the accuracy between the data and its references – from acquisition, over storage, all the way to destruction of the data.
Key to data integrity is the introduction and implementation of a holistic information management strategy. Starting point is the identification of data and data flow. On that basis, sustainable processes for the secure handling of data in all divisions of the company are implemented.
We are specialised in the life sciences industry, and are familiar with the regulatory requirements regarding data integrity (FDA, EMA, MHRA).
Data Integrity Awareness Training
The team is a crucial element. Deliberate falsification is not the factor behind most data integrity violations. Most of the time, these are just a result of simple lack of knowledge, negligence, or even a wrong management strategy. Are your employees aware of what is most important? Our awareness training is there to throw light on and create awareness of the hurdles, and demonstrates how to avoid them.