Lab Investigation | OOS Software

Manage your lab investigation with consistency and ease

New Lab Investigation Application efficiently tracks, trends & resolves problems identified in laboratory testing.

A systematic, thorough approach to lab investigations

ETQ Reliance’s® Lab Investigation software app helps to document the investigation process of an Out of Specification (OOS) or Out of Trend (OOT) lab test result.

Users now have the ability to investigate an OOS or OOT result to determine the cause of the result, and through the investigation process, conduct re-sampling/re-testing to confirm the test results.

Investigate the root causes of OOS results

Lab Investigation can help determine risk. A user has the ability to generate a corrective action (CAPA) or Nonconformance material report (NCMR) after determining if one is required. In many cases, Lab Investigation can eliminate the need to undertake a more costly and time-consuming CAPA.

From the Lab Investigation application, users can directly initiate the CAPA or NCMR, as the applications are connected through the ETQ Reliance platform.

Chemist filling vials in experiment at laboratory

Efficiently track, trend & resolve

The application was designed for not only life sciences customers, but any industry that tests products in a laboratory. Unexpected lab results require further investigation, which can help define if there is a need to generate a costly and resource-intensive nonconformance or CAPA. The integrated Lab Investigation application streamlines that process, reducing the time to resolution.

For organizations that must comply with cGMP and 21 CFR Part 210 and 211 requirements such as pharmaceutical and combination product makers, Lab Investigation enables you to capture and track your processes and results.

 

ETQ Reliance Lab Investigation software helps you determine the risk of lab investigations

Build consistency

Provide a standard process definition that everyone follows when performing a lab investigation. This will ensure that each investigation is consistent.

Increase visbility

Track the results of each investigation and identify trends for root cause analysis.

Stay compliant

cGMP and 21 CFR part 210 and 211 requirements guide the process for investigating OOS & OOT lab results

Reduce time to resolution

The integrated Lab Investigation application streamlines that process, providing increased traceability and reducing the time to resolution.

Now that you’re here…

Why not take a minute
to find out more about ETQ Reliance.

ETQ Quick Read

The 8 Elements of an Effective Document Control System

Learn what to consider when planning and implementing your document control system.

Read Now