If someone asks you about your data integrity, do you know what exactly that entails? Often, we don’t know what exactly data integrity means, we just know that we want it and need to keep it in place. While it is true that data integrity is important and needed, it is also important to understand what all is involved with data integrity.
What is Data Integrity
Data integrity involves the accuracy, completeness, and quality of the data, how it is maintained over time, and how it is maintained across formats. The goal is to keep your data complete, consistent, and accurate throughout the lifecycle of your data.
A common reference tool that is used when comes to data integrity is to use the ALCOA principles. ALCOA has six principles at its base. They are as follows:
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
- Complete
Each of these principles represents a pilar upon which your data integrity rests. If you have all of them, your integrity is in place. If any of these pilars are missing, then your integrity falls apart.
It is worth noting that data integrity and data security are two different concepts. Keeping your data secure is a part of keeping the integrity of your data, but security and integrity are not the same.
Data Compromises
There are several ways in which data can lose integrity and become compromised. Some points to consider are things like these:
- Human error
- Inconsistencies across formats where the same data is being used
- Data collection error
- Internal or external privacy breaches
When it comes to validations and calibrations some of these points are more likely to happen than others, but there is a chance that any of these four points could be a part of your study and the data that is collected from that study. So, all these points should be considered.
Regulations
There are numerous major international regulatory agencies that have published guidance documents to address data integrity and data management. The overall goal of all these agencies is to increase and include data integrity requirements into your studies. The agencies also place a certain level of expectation on you with this guidance:
- Incorporate Data Integrity / Data Management into Quality System.
- Risk Assessment on all aspects of Data Integrity thru lifecycle of products.
- Validation of all computer-based systems for CFR 21 Part 11 / Data Integrity compliance.
- Ensure Audit Trail reviews as part of Batch Record reviews
- Ensure Data Integrity / Data Management programs are part of internal and external audits.
Data Integrity & Kaye
At Kaye, we know that your data integrity is important for you and your studies. When it comes to our validation systems, they all have numerous compliance points in place to keep the integrity of your data. First and foremost, our systems enable compliance to 21 CFR Part 11 standards. This is a security standard from the Food and Drug Administration (FDA) that aims to keep electronic records safe and secure. The system also has enhanced security permission levels that produce user lists for your review of user activity.
Another big point is that many of our products offer several features that can assist you when it comes to an audit. Your data integrity, along with your studies themselves, are all subject to audits. Our validation systems have an enhanced audit trail features in place to help you for your audits. Some of these features include:
- Inclusion of any applied filtering of Audit Trail in Audit Trail report
- Include permission rights into Users List
- Expanded Auditable events
- Inclusion of Time Zone into reports.
Bottom Line
Often, given the fields in which our products serve, someone health and safety can be on the line when it comes to the information and data that we collect. Keeping the integrity of that data is so important and can be a matter of life and death. The accuracy, truthfulness, and having data that is complete is so important.
At Kaye, we understand that fact as well and want to help ease that burden as much as we can. Our products have so many great features that can assist you with your data integrity. A great place to start is to request a demo with one of our knowledgeable account managers to allow them to not only show you our products, but all the awesome features they have that can help you.
To request a demo, please visit our demo request webpage here: https://www.kayeinstruments.com/en/demo
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