Written by: Chris Pardo, Associate Business Development Manager
When you run a test and you get a result or OOS you don’t like, you wish you could delete it and just run a re-test, but we don’t. There is a very good reason we do not do this and you probably aren’t aware you are already complying with data integrity. Data integrity is essential for the life science industry. Most people don’t know why we have data integrity or what it is. Let’s go into what data integrity is and why it is important to maintain.
What is Data Integrity
We all have heard the phrase, “if it isn’t written, it didn’t happen”. Data integrity follows that, but takes it up a notch and expects the data to be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (commonly known as ALCOA). To ensure that data integrity is being met, there must be a record of anything that is changed from the original document while keeping the original document intact. When making a change a reason must be given and recorded. This brings us to an audit trail.
Following the Trail
The FDA defines an audit trail as a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the events relating to the creation, modification, or deletion of an electronic record. The audit trail shows us who made changes, why the changes were made, when they were made and what changes were made
What it All Means
What data integrity means is that not just anyone can either alter data, erase it, or make any changes to a document without a record of the changes being made in an audit trail that can be reviewed. Severe penalties can occur due to not following data integrity such as a warning letter and criminal prosecution. Everything is recorded and made available for review by anyone.