Establishing a dedicated process enables a business to streamline triage, investigation, and problem-solving—effectively future-proofing itself against potential issues. An Out-of-Spec (OOS) software, such as ETQ’s Quality Events app, plays a crucial role by creating a standardized process that ensures every investigation is conducted consistently, promptly, and with the correct steps taken in the right order.
Lab Investigation Application from ETQ Reliance OOS software efficiently tracks, trends & resolves problems identified in laboratory testing.
OOS Software APP
ETQ Reliance’s® OOS 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 Out of Specification or Out of Trend result to determine the cause of the result, and through the investigation process, conduct re-sampling/re-testing to confirm the test results.
OOS Investigation software 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, OOS Investigation can eliminate the need to undertake a more costly and time-consuming CAPA processes.
From the Lab Investigation Out of Specification software, users can directly initiate the CAPA or NCMR, as the applications are connected through the ETQ Reliance quality management platform.
The interconnected OOS software 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 Out of Specification software 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 from ETQ Reliance OOS software enables you to capture and track your processes and results.
Provide a standard process definition that everyone follows when performing a lab investigation. This will ensure that each investigation is consistent.
Track the results of each investigation and identify trends for root cause analysis.
cGMP and 21 CFR part 210 and 211 requirements guide the process for investigating OOS & OOT lab results
The integrated Lab Investigation application streamlines that process, providing increased traceability and reducing the time to resolution.