One of the most essential roles of a laboratory information management system is to ensure data integrity for the laboratory.  This has always been the case, but the LIMS security requirements are always expanding.  The capabilities of modern software systems can be quite sophisticated.  But they are not evenly implemented across products, and not always leveraged by all laboratories.  In this article we will provide a broad overview of the capabilities you should be considering.

LIMS Security

The most fundamental prerequisite for ensuring data integrity is a robust security feature set.  A configurable, role-based security model is commonly viewed as a best practice.  Users should only be able to modify the data that is relevant for their role and their qualifications. And even if they are granted the ability to enter or change data, it should only be at the appropriate times. Test results that have been reviewed, approved, and reported, should not be able to be changed without tight controls. If reported data did need to be revised, the system should be set up to limit the change to a specific set of individuals.

Historically, most applications managed their own authentication.  A better, more secure approach is “Single Sign On”.  This allows IT to enforce standard rules for passwords and centrally disable accounts when needed.   User experience is also improved because they don’t have to learn another set of credentials.  Instead, they can login to LIMS with the same credentials that they login to their computer.

The product of most laboratories is a test report. The most common format for that report is PDF. Most laboratories do not take advantage of the full security capabilities of this format, however.  These features allow you to guard against the unauthorized alteration of the report.  Encryption, password protection, and view only permissions should be offered by LIMS.

Wavefront Software utilizes secure cloud configurations to ensure our customers enjoy the peace of mind that their data is secure. Find out more and schedule a demo today!

Traceability in LIMS

The system must fully audit laboratory test results and make that audit history easily accessible to users, managers, and quality personnel.  The audit history should capture who changed what, and when.

Occasionally, analytical data is captured that is deemed to be invalid in subsequent review.  When the laboratory elects to not report or otherwise use recorded results, LIMS must provide the capability to do so in a way that ensures that data is never deleted.  It should also be apparent to those charged with peer review and final approval that these decisions were made and allow those persons easy access to the full history of the data.

Electronic signatures should be available throughout the product, aligning with the procedures the laboratory has implemented.

All laboratories will have to revise reports for one reason or another. Each revision of that report should be maintained. Reports that are revised should have revision history incorporated into the report.  The reader of the report should be able to clearly see that the report was revised, why, and when.

Eliminating Manual Data Entry

Where possible, the laboratory should seek to eliminate manual data entry.  Interfacing instrumentation to LIMS not only improves quality, but it increases efficiency. Learn more about efficient methods for populating data into LIMS in this article: “Populating Data into LIMS“.

LIMS Quality Control

A laboratory information management system should facilitate the management of laboratory quality control, such as:

• Capturing QC data
• Understanding if laboratory QC meets requirements.
• Providing control charts
• Alerting the appropriate personnel when QC fails
• Providing alerts for laboratory processes that are drifting out of control – before they fail.

Manufacturing Quality Control

If the laboratory is serving a QC function for manufacturing processes, the LIMS should be able to compare test results to one or more product specifications.  This allows for the automation of passing and failing of tests.  The final lot pass/fail usually occurs after review.

Data Backups

An important foundation of any data integrity is making sure that data is adequately backed up.  Historically this has meant a “nightly backup”.  Today, for most organizations, this is simply insufficient.  “Point in time” backup and restore allow for the laboratory to pick any point during some reasonable window (last 30 days) and restore a database.  Having the data stored in a geo-redundant location is also critical for preparing for disaster recovery.

Summary

Unlock the secrets to maintaining impeccable LIMS data integrity mentioned here and more with Wavefront LIMS. From robust security protocols to streamlined data entry methods, we offer essential strategies for safeguarding laboratory information. Learn how Wavefront LIMS offers advanced features such as configurable security models, comprehensive traceability, and efficient data interfacing, ensuring not only data integrity but also enhancing productivity. Ready to experience the power of Wavefront LIMS firsthand? Request a demo today and revolutionize your laboratory management processes.