Data Integrity is an increasingly important topic in the Pharmaceutical Sector. Partly because it is on the agenda with the regulatory bodies and a topic for inspections, resulting in a significant number of observations, FDA Warning Letters and EU Non-Compliance Reports.
Specializing in Pharma and IT we have been assisting preparing for a Pre-Approval Inspection, where Data Integrity is expected to play a vital role. So, if you are looking to improve the Data Integrity Awareness- and Compliance Level in your organization, we suggest you to seek inspiration in the below approach.
1. Data Integrity Awareness
This is done through a multi-channel approach.
First and foremost, through class room training with the basis of the ALCOA+ principles. The class room training approach has the advantage of enabling a discussion of good and bad data integrity practice in the company – and it also acts as a hook to the next step, identifying gaps, as the participants can raise concerns related to specific processes, systems and equipment.
Other awareness channels include post on intranet and an updated policy for all employees.
2. Identifying Data Integrity gaps
Second step is go through the selected processes, systems and equipment. The selection can be a gross list approach or a risk-based approach, according to scope and time available. In this step the process is analyzed from a data input point of view, a process- and process governance point of view and lastly a data output point of view. This step covers more than 50 data integrity related questions. This means that the process is thoroughly described, and the result is that potential gaps are listed and reported.
3. Closing gaps
A plan is made to close identified gaps
If you want to know more about the suggest approach or our recent project, please feel free to contact our Data Integrity Subject Matter Expert Jesper Damborg Bendtsen or Project Manager Peter-Emil Iversen
…. and if you are in for a data integrity laugh, check this song. Be warned – it might get stuck in your head 🙂