I want to speak to the heart of the matter of data integrity, because I think that it will be of help to folks when setting up related systems or attempting to improve them. The purpose of data integrity controls is to make sure that each assay or procedure can accurately depict who, how, what, when, where and why any piece of data came about. If we can delete files, overwrite files with retested results, alter date and time stamps, and fill in batch records weeks after the process is completed, we alter the picture of the data and make it difficult to decipher. Controls to computer/software systems, forms, data storage and the like are necessary to have an environment where human error does not take away from the integrity of the data and to ensure that CFR regulations are being followed. It’s important to have a deep understanding of data integrity and its impact on the drug approval and manufacturing process.
In 2015 the FDA issued 23 warning letters of which 14 cited data integrity issues. Because of the high occurrences of data integrity issues, the FDA recently released a draft guidance for data integrity. This guidance is approximately 10 pages long, I encourage companies have employees read this guidance as part of their training, especially personnel in manufacturing, analytical or quality groups. This guidance gives key definitions regarding data integrity, cites the appropriate CFR’s and has a section written in question and answer format. It addresses computers and software validation and controls, validating work flows, data storage (electronic and paper), audit trails and much more.
Remember the purpose of data integrity is to paint an accurate picture, not to hinder the process in which work needs to be done. For instance, does having data integrity mean that you can never manually integrate a chromatogram? No! It just means you need to have a system for recording why and how the manual integration is being performed. Likewise, other functions can be performed, they just need the proper system for painting a picture of all the circumstances around the function. Another example would be performing a re-test. A re-test can be performed on a sample under the correct conditions and if accurately documented through a lab investigation. The work that needs to be done can still take place, with scientific justification and with a very systematic and documented approach.
Proper data integrity will protect companies because files (electronic or paper) will be stored in a way that’s easily retrievable and backed up properly. Part of this guidance addresses backup copies of data and what is acceptable. When I read this portion of the guidance for first time, I asked myself, who would not want to have safe back up storage of their electronic data files? Most companies will find that implementing these guidelines really helps to set them up for success both for meeting regulations and for keeping their data safe.
Data integrity is a large topic with many facets that affect every day work in the pharmaceutical industry. If you are interested in more information on data integrity, there is a webinar link on my website. If you need assistance with setting up systems or strengthening them contact Monsef Consulting through the website!