Data integrity is one of the most critical factors in any regulated industry. This is because any data error could lead to profound consequences in a regulatory audit. Data integrity is defined as the assurance and maintenance of data consistency and accuracy throughout its life-cycle1. It is important to keep data consistent from start to finish in a regulated industry.
Data integrity are standardized across the industry to achieve high-quality product and better processes. The ALCOA principle states that data should have the following five qualities to maintain data integrity:
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
Attributable is the first term of ALCOA, all data should be attributed to the individual that generates it. This includes details of the individual and a timestamp of when the action was performed, this step can be completed physically or electronically. The second term is Legible, all recorded data shall be permanent and easily legible. Permanent means the information can not be changed or altered, the best practice is to utilize ink that can not be altered or erased.
Contemporaneous is an especially key factor in the ALCOA process because all data should always be recorded at the actual time of the action or when the work is being performed. Data should not be recorded retrospectively to align with data credibility. To be contemporaneous ensure all clocks are properly synchronized during the testing process to eliminate any errors.
All data should be in its original forms, such as protocols, databases, or notebooks. Do not record data on one entity and transfer it to the official test documents. Lastly, all data should be accurate. This includes all observations to be free of errors, truthful and complete. It is important to always review for accuracy before sending documents off for approval in the industry. If your company has issues with data integrity and would like to perfect your ALCOA processes, EMMA International is here to help. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.
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1Pharma Guidelines (2018). Principles of Data Integrity, Retrieved on APR 25, 2022 from https://www.pharmaguideline.com/2018/04/principles-of-data-integrity.html#comment-form
