Out of Trend Software
The chemical, instrumental, microbiological, and physical analysis of the raw materials and finished goods samples generates a large amount of informative data for the Life Sciences Industry from the Quality Control Labs. Drug production companies use QC Sample Out of Trend (OOT) to make sure that the products meet the laid down specifications. This important information will be used to predict and revise alerts and action limits for quality specifications. In a case where sample results differ or deviate from the sample’s historical results, a case of Out of Trend must be investigated.
When a drug or product doesn’t meet the requirements, it’s classified as Out of Trends. Following FDA guidelines, it is very important to resolve quality issues effectively after a phase-wise investigation.
A member of the QC team will look into the source of the OOT results of the sample, starting with the Initiation of OOT Result.
It is then followed by the Phase I Investigation, the Phase 2 Investigation, and the QA decision. Each Investigation does have its own set of sub-steps.
- To identify correctable errors, OOT Phase I investigates the sample in depth. A thorough laboratory investigation includes an investigation by the Supervisor and Analyst, a Root Cause Analysis, a Repeat Analysis, and the start of a CAPA.
- Phase II of the OOT investigation, also known as full-scale integration, includes an investigation into the sample. It includes the selection of an investigation team, Root Cause Analysis, Raise Deviation, CAPA initiation, Product Impact Assessment, and Quality Risk Assessment. Part of the Hypothesis Design process includes conducting Laboratory Failure Investigations.
- Following a thorough investigation, with the assistance of the QC HOD, the QA will decide on the Batch disposition depending on the OOT Results.
Having a simplified system in place that aids access to information, accelerated investigation, and issue traceability is one of the challenges with a manual process OOT Management System with a large number of samples. Warning letters, plant audits, and investigations from the Food and Drug Administration (FDA) highlight the necessity for pharmaceutical and biotech companies to use Sample OOT Automation and Trending Software to enhance the investigation process and facilitate better communication about the problems between different departments.
AmpleLogic’s electronic OOT Tracking Software is built on a Low Code No Code (LCNC) Platform. It can store and recover all appropriate documents based on the needs of the organization.
This Out of Trend Software ensures compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, GMP, and other international and national manufacturing standards.