Does Your Scale Have an Audit Trail Feature?

Data integrity means the completeness, consistency and accuracy of data. In the pharmaceutical industry, data integrity means ensuring and guaranteeing the accuracy and consistency of data throughout the product manufacturing process. Since our country is now a PIC/S member, data integrity has become the most discussed topic in the pharmaceutical industry. Data integrity is one of the fundamental elements in the pharmaceutical quality system that ensures medicines are of the desired quality. This data integrity feature is a desirable condition for all equipment used in production and laboratory. Balances used in the pharmaceutical sector must fully comply with data integrity. One of the most important requirements of data integrity is audit trail. Audit trail is a chronological record related to security that provides evidence of the action performed on the device at any time, affecting a particular operation, procedure or event. Audit trail is an electronic record that provides the validity and integrity of the recording made on the balance and the connection between it and any associated record with an electronic signature. The purpose of the audit trail feature is to make the electronic data on the balance secure and traceable. Audit trail is a legal requirement in pharmaceutical manufacturing. Audit trail ensures record integrity and security on the balance. It is a regulatory requirement and should be present in all devices and equipment that record real-time data.

Audit trail data should be protected immutably and should not have an option for modification or deletion. The following information should be recorded in the audit trail.

1. Date and time. 2. Name of the person making the change. 3. Original and modified value. 4. Reason for the change made. 5. Invalid login attempts should also be recorded in the audit trail. The audit trail feature is included in 21CFR Part 11: Electronic Records and Signature, FDA: Data Integrity and Compliance with cGMP, EU-GMP Annex 11, MHRA: GxP Data Integrity and Definition for Industry, WHO: Guidance on Good Data Record Management Practices. Of these; according to 21CFR Part 11, a system with audit trail feature should include the following: 1. Records should be protected and their accuracy and readiness should be ensured during the storage period. 2. Access to the system should be limited to authorized persons only. 3. The system should record the date and time of entries used and action, modification and deletion of records in the system. These records should be displayed during system review. Audit trail reports can be reviewed to identify system security issues, errors in event sequencing, investigation of errors and unexpected events, training issues and data integrity incidents. After laboratory managers determine which process needs to be monitored, regulations provide context on what is required as part of the audit trail. In particular, FDA 21 CFR 11 specifies that an audit trail must be secure, time-stamped, computer-generated and must not delete or conceal previous data. Similarly, EU GMP Annex 11 paragraph 12.4 states that "management systems for data and documents should be designed to record the identities of operators who entered, modified, approved or deleted data, including date and time." PIC/S as of August 2016 in the "Good Practices for Data Management and Accuracy in Regulated GMP/GSP Environments" draft also defines Audit trails and presents comprehensive review requirements. Mustafa Yetim Sales and Marketing Manager Sartonet Separation Technologies A.Ş.