A lab audit can be a big headache, but it doesn’t have to be. Automation of routine processes is a crucial step toward working in accordance with strict clinical regulatory requirements. The greater challenge of providing an auditor with proof of compliance can be solved with the right automation system.
Countless processes in the clinical laboratory that were once only performed manually are now easily automated. Whether the task is complex or relatively straightforward, such as liquid handling, the benefits of automation are undeniable. For instance, an automated liquid handling system can perform multiple tasks simultaneously and run far more efficiently than a human operator. By enabling the use of smaller volumes, an automated liquid handler can cut down on the use of reagents. Liquid level detection makes automated liquid handling far less error prone and more reliable than manual liquid handling. The list of benefits goes on.
An often-overlooked benefit of automated systems is the protection they afford labs operating in highly regulated environments. All clinical laboratories are required to fulfill certain regulatory requirements. Of these, one of the most common—and the most stringent—is FDA 21 CFR Part 11, which defines the set of criteria under which electronic records and electronic signatures are considered trustworthy and reliable.
How can an automated system help clinical labs maintain compliance with rigorous regulatory norms, like FDA 21 CFR Part 11?
Any automated system should offer a few fundamental features to support regulatory compliance. Sample barcoding and tracking enable the identification and traceability of precious samples as they move from the sample preparation stage through to reporting of results. An audit trail that tracks system and electronic changes helps to ensure that there have been no external manipulations to the system or records. This must include electronic signatures as a means of user authentication. User management features that control who can log in and out and make changes to the system safeguard against significant alterations being made by unauthorized users.
Sample tracking, audit trails, and user management can be considered the basic features that an automated system should offer in order to function in a regulatory environment. But to be truly audit-ready, a clinical lab is wise to invest in a system that also offers more advanced features.
When it comes to being audited, the clinical laboratory bears the burden of proof. It’s not enough to simply work according to regulatory standards; the clinical lab must be able to prove that it has been—and continues to be—compliant. An ideal automated system should therefore include a tool that verifies the integrity of all executable software components and electronic records, in a human-readable format, at the push of a button. An auditor must also be able to see that only approved and validated protocols are being used for day-today activities. While method approval and a dedicated audit tool are not features typically found in an automated system, they greatly help in facilitating a quick and pain-free audit.
THE FLUENT® GX
The Fluent® Gx, Tecan’s liquid handling workstation, is specifically designed to meet the regulatory needs of clinical laboratories. Its associated Fluent® Gx Assurance software includes a suite of basic and advanced features that enables clinical labs to comply with strict regulatory requirements, including FDA 21 CFR Part 11. Key features include:
- Electronic signatures provide an audit trail that tracks all system and electronic record changes.
- Scanned primary tube barcodes can be linked with destination plate positions and pipetting results.
- User management offers three default user groups: operators who can run the instrument but not make changes, key operators who can use the method approval feature, and administrators who may enable or disable user accounts.
- The Data Audit Tool proves that no external manipulations, additions, or deletions to the system or record have occurred.
- The Method Approval feature enables the release new or edited methods.
Beyond simply providing the tools for compliance, the Fluent® Gx also helps users prove their compliance. With the system’s advanced features, a lab audit can be completed with relative ease—and without a big headache.
This InFocus feature was crafted by Clinical Lab Manager’s Creative Services team and sponsored by Tecan.