Streamlining Lab Investigations
ETQ Reliance QMS offers a comprehensive solution for managing lab investigations with consistency and efficiency. By utilizing Out-of-Spec (OOS) software, businesses can establish a dedicated process that streamlines triage, investigation, and problem-solving, effectively future-proofing themselves against potential issues. This standardized process ensures that every investigation is conducted consistently, promptly, and with the correct steps taken in the right order.
Functionality of OOS Software
The OOS software app from ETQ Reliance provides users with a systematic and thorough approach to lab investigations. It allows for the documentation of Out of Specification (OOS) or Out of Trend (OOT) lab test results, facilitating the investigation process to determine the root causes of unexpected outcomes. Users can conduct re-sampling and re-testing to confirm test results and identify risks. Additionally, the software enables the generation of corrective actions or Nonconformance material reports (NCMR) promptly, reducing the need for costly and time-consuming processes.
Efficiency and Compliance
ETQ Reliance's OOS software efficiently tracks, trends, and resolves problems identified in laboratory testing. It is designed not only for life sciences customers but for any industry that conducts product testing in a laboratory. By streamlining the investigation process, the software reduces the time to resolution and provides increased traceability. Organizations subject to cGMP and 21 CFR Part 210 and 211 requirements, such as pharmaceutical and combination product makers, can benefit from ETQ Reliance's Lab Investigation OOS software to capture and track processes and results while ensuring compliance.
Key Benefits of ETQ Reliance OOS Software
ETQ Reliance OOS software offers several key benefits, including the ability to provide a standard process definition for lab investigations, increase visibility by tracking investigation results and identifying trends, ensure compliance with regulatory requirements, and reduce the time to resolution by streamlining the process. The software helps organizations build consistency in their investigation processes, enabling them to effectively manage risks and address issues promptly.
Enhanced Quality Events Application
ETQ Reliance's Quality Events Application complements the Lab Investigation OOS software by providing a comprehensive platform for managing quality events. By leveraging these integrated solutions, organizations can enhance their quality management processes, improve visibility and traceability, and ultimately drive operational excellence.