On November 15, 2021 GMP Trends® posted Issue #1076 featuring observations pertaining to data integrity and whether this data is secure. This report is used to notify other manufacturing companies and raise awareness of incidents that others are not unaware of or simply attempt to ignore. Manufacturing companies need to acknowledge and follow the rules of importing data and understand the importance of importing their results into their systems, tracking when information is altered and having a supervisor review data. It is important for manufacturing companies to understand the guidelines set by GMPs, FDA and the Code of Federal Regulations (CFR) specifically 21CFR Part11 electronic records guidance.
In the 483, this manufacturing company was reported for not having correct controls on their systems— such as, where they store and secure their data information. Data was stored in an excel spreadsheet; where data can be altered or deleted without any trace of changes and has no audit trail. This violates 21CFR Part11 guidance for electronic records quality assurance. It is noted that data is not reviewed by any supervisors— giving more room for inspectors to make mistakes. The supervisor granted these controls to all the QC employees, leading anyone to approve, change, delete and information they needed in order to approve a drug product to be sent out for patient use.
This manufacturing company did not have their spreadsheets validated; therefore, the data being imported should not have been accepted. Manufacturing spreadsheets need to be formulated and challenged to serve to store raw data, derive calculations or display trends.
With InQuest Science’s Identifier software is secure and easy to import product inspection results or defect control information required by USP-790/1790 while following all current guidelines for data integrity. Data is stored, tracked and traced all within one system. Reports are easy to access and printable. This shows proof of all data imported and deleted, who double checked the data and qualifications needed for the specific product. This software is versatile and could be used for many data storage options.
InQuest Science could help reduce issues with data and qualification integrity, quality assurance and tracking product information.
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