What is Data Integrity?
Data Integrity is the extent to which all data is complete, consistent and accurate throughout the data lifecycle. It must be attributable, legible and contemporaneously recorded and have an original copy.
Data Integrity is a major issue that isn’t confined to just one area. Many manufacturers may not realise that data integrity in the manufacturing process is the most important aspect in the process. The integrity of data generated by medical device, pharmaceutical and biotechnology manufacturers is extremely important.
Properly recorded information is the basis for manufacturers to ensure product identity, strength, and safety.
It’s highly recommended that manufactures use an electronic system as it makes it easier to have control over the data and information. Utilising an electronic system where this information is locked down, automatically time stamped, and can’t be maliciously altered allows for greater confidence in the data.
Manufacturers need to be assured that regardless of where information is stored, the system’s data is never invalid, falsified, or adulterated. User access to the system must require authentication (special signatures) and these systems should implement stringent document control, so any changes can be traced back to individual users.
Not being compliant can lead to warning letters and regulatory action from governing bodies. Every year there are reports of manufacturers falsifying data to get the products into the market as quickly as possible.
Data Integrity can be comprised in numerous ways whether it be human error intentionally or unintentionally. Transfer errors, including unintended alterations or data compromise during transfer from one device to another.
Ultimately, Data Integrity can come down to life or death circumstances and you want to make sure your data is 100% accurate if governing bodies come back to your business.