Did you know that 65% of warning letters issued by the FDA cited data integrity problems in 2021? That is a massive spike from 2020, where 51% of the 483s cited data integrity as a problem. Data integrity is a critical topic in pharma manufacturing. Despite the FDA’s ‘set-in-stone’ guidelines, we see numerous 483s citing data integrity as an issue each year. And this problem exists globally.
What is data integrity?
Data integrity is the practice of maintaining and ensuring the accuracy of data consistently during the manufacturing of a product. All records during the manufacturing process need to be validated as per FDA’s guidelines. Any change to the data without reflecting in the records is considered a failure of data integrity.
It involves ensuring which user created and saved a record along with date and timestamps and that all data is accurate, consistent, and complete, making it reliable and trustworthy.
It is important to note that FDA has not made any changes to the definitions or regulations or expectations in recent years. There have not been any new guidelines or regulations in the category. This clearly indicates that the companies have not been able to implement the requirements satisfactorily.
To ensure data integrity, pharma manufacturers need to ensure all data meets the guidelines outlined in the ALCOA acronym:
- Attributable – All information about the person collecting the data, the origin of the data, and the timestamp of data collection.
- Legible – Data should be easy to read.
- Contemporaneous – All data must be recorded as and when the activity is done.
- Original – The original data records need to be preserved throughout their life cycle and be long-lasting.
- Accurate – Data needs to be error-free and high quality, with all changes being reflected in the supporting documentation.
