Data integrity is the assurance of the accuracy, maintenance of and consistency of the data. The concept of data integrity has been applied for many years. However, it has become more acute recently since auditors are paying more attention to data integrity than before. The FDA, EMA and other regulatory bodies have also set new regulation guidelines that need to be adhered to.
When it comes to the calibration procedures, there are common places for data integrity pitfalls. These issues need to be addressed whether the calibration process is paperless or fully paper-based. You need to have experts who will offer specialized calibration equipment and repairs to ensure accurate measurements. Let’s take a look at the most common data integrity pitfalls.
Calibration needs to be recorded for analysis purposes. Sometimes older calibration results need to be compared with new results which mean that these records need to be easily accessible. Most industries use paper archives which makes record keeping a big task. To make the process easy, it is best to adopt an electronic system that can easily search for older records when the need arises.
Typing Errors, Loss Of Papers, Poor Handwriting
Paper based systems do have a lot of issues like poor handwriting and loss of papers. A reading will be taken from a measuring device, written on paper and later on typed into an electronic system. If the handwriting is not legible this can lead to typing errors which compromises data integrity. To take care of this problem, it is best to invest in modern electronic documenting calibration equipment that transfers data automatically in an archiving computerized system. Manual data inputs are time consuming and there is also the risk of losing some papers in the process.
Some electronic systems do not have proper controls for backdating actions. For example, if you need to backdate a calibration it may be hard to control the time/date settings. A paper based system is difficult to control the date and time written and it becomes hard to backdate any actions in case you forgot to do it in time. Despite the type of system you use, it is not possible to tamper, modify or edit any original calibration data once it has been recorded.
Delete, Undo Calibration Points
Electronic systems are designed not to allow data tampering, deleting or undoing once it has been recorded. This is so to avoid compromising data integrity. In case there are data entry errors and you need to redo the whole process, you are supposed to keep the original calibration data as originally witnessed. This does not mean that calibrations cannot be repeated. If the SOP requires doing several calibration repeats, you can still do this but you should never delete any original data prior to that.
User Rights And Passwords
An electronic system needs to have an audit trail to help keep track of records and modifications and who did the entry. The system needs to be installed with user rights and passwords and only authorized personnel are allowed to access the system. There should be no shared passwords which go against the FDA regulations. In case there are any changes that need to be made in the electronic system, a member of staff is required to use his or her electronic signature.