GMP trends published “Are you protecting your lab data from deletion or alteration?”
In this newsletter it explains a 483 that a manufacturing lab was caught altering data information. This lab manufacturer did not have a protected system for their data, meaning information is not locked down after being inputted. Information can be altered or deleted without trace in an audit trail.
Based off of CFR part 11—people who use electronic systems to create, modify, maintain or transmit records, should follow a procedure that honors integrity and authenticity. Manufacturers should ensure that each employee is following the correct procedure and CFR part 11.
Falsifying data could lead to major recalls in drug manufacturing, harm patients and could cause lawsuits against the manufacturer. Having correct data could save manufacturers a lot of money. Data integrity is continuously enforced, but cannot penalize a specific person if violated; due to the inability of paper-based data platforms tracing back to a specific person.
InQuest Science’s Identifier Software keeps track of all data entries, alterations and deletions in a printable audit trail. With any new data submission or change, a supervisor’s approval is mandatory with a “sign off” to ensure the data entered is checked and accurate—following CFR part 11. Our software’s audit trail is easily accessible to pin point where mistakes are coming from; as well as who is responsible. The Identifier Software supports a better workflow, allowing all data information to be imported into one site. Paper-based data platforms will no longer be needed.
