Out of Trend

Out of Trend Software

The Life Sciences Industry generates a large amount of informative data from the Quality control Labs on Chemical, Instrumental, Microbiological and Physical analysis of the raw materials and finished goods samples. QC Sample Out of Trend (OOT) is used by drug manufacturers to ensure that drug products are produced within the defined specifications. This valuable information will be utilized to forecast and revise the alerts and action limits for quality specifications. When there is a variance or aberrance in the sample results as compared to the historic results of the sample then an Out of Trend  needs to be investigated .Whenever the drug or product does not meet the specified standards, it leads to a result of Out of Trend. As per FDA guidelines the most important thing is that quality issues are effectively resolved after phase wise investigation,

A QC personnel shall investigate the cause for OOT results of the sample which begins with the Initiation of OOT Result. It is followed by Phase I Investigation, Phase 2 Investigation and the QA decision. Each Investigation has its own sub steps.

  • OOT Phase I Investigation of Sample includes Preliminary Investigation to identify correctable error. A detailed laboratory investigation includes investigation by the Supervisor and Analyst, Root Cause Analysis, Repeat Analysis and CAPA initiation.
  • OOT Phase II Investigation or Full-scale integration includes Manufacturing investigation of the sample. It consists of the Investigation team selection, Root Cause Analysis, Raise Deviation, CAPA initiation, Product Impact Assessment, and Quality Risk Assessment. This phase also includes the conducting of Laboratory Failure Investigation as part of the Hypothesis Design.
  • After a detailed investigation QA will take a decision on the Batch disposition based on the OOT Results with the help of QC HOD.

The challenges with manual process OOT Management System with the large no of samples is to have a streamlined system in place which facilitates accessibility to information, accelerated investigation and traceability of the issue. Food and Drug Administration (FDA) warning letters, plant audits and investigations reinforce the importance of Pharmaceutical and biotech companies to adopt Sample OOT  Automation and Trending Software that improves the investigation process and enables better communication of the issue between different departments

AmpleLogic offers electronic OOT Tracking Software is developed on LOW CODE PLATFORM. It has the ability to store and retrieve all relevant documents based on the organization’s requirements.  Out of Trend Software will ensure compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, GMP and other international and national standards which govern manufacturing practices

OOT Management Solution for Quality Control Laboratories

Sample OOT Management Software allows the Quality Unit of an Organization to manage an OOT from initial reporting of Sample information through a failure investigation, to implementing any associated CAPA and eventually closing the OOT through an automated and streamlined platform.

This enables the organization to reduce reporting time,  analyse the task for repetition, easily access previous summary reports or trends, and break the investigation down to smaller tasks like review tasks, and re-analysis tasks. These tasks can then be assigned, completed and tracked. The post investigation procedure includes the initiation of associated CAPA and its implementation. This is followed by effectiveness checks carried out through the CAPA management System. As a result, the system reduces closure time through notifications, auto escalations and integration of systems.

Amplelogic Sample OOT Tracking Software will transition to your environment in a short time. With the help of this comprehensive tracking and trending system you will be able to automate the generation of metric reports and summarized Reports of each sample with a click of a button.

The Summary Report gives you real-time summarized information within a specific OOT and its metrics reports. It supports better visibility and traceability of the OOT at any given point of time.

In addition to providing the best approach for effective closure of OOT, the software is absolutely compliant with electronic records and management regulations like 21 CFR part 11. The software achieves this by providing organizations with complete audit trails, electronic signatures, controlled access, thorough records managements, controlled printing and archiving in accordance to policies and regulatory standards of an Organization

Out of Trends Automation Advantages for Analytical Laboratories

It has been developed after extensive research on out of trend guidelines from various regulatory agencies like US FDA, MHRA and WHO GMP. It is designed to be practical and problem-oriented with these core benefits:

  • The software is accessible round the clock by authorized personnel throughout the organization and coordinates failure investigations effectively.
  • Out of Trend solution will comply with Pharmaceutical and Biotech Industry regulations. These include 21CFR Part 11, EU Annexure11 as well as cGMP and GMP guidelines (Good Manufacturing Practices), etc
  • Harmonization and Accuracy in initial data capture through business logic applied to the fields such as rounding off results to two decimals
  • Fast-track investigations prevent delays in customer shipment and ensure product quality/ safety
  • Automated triggering of second phase investigation based upon the conclusion of the first phase
  • Ensure live tracking and traceability of status, automated email alerts, and notifications
  • Improved OOT Closure timelines with workflows promoting best practices
  • Easily integrates and establishes closed-looping with other Quality Systems such as CAPA
  • Customizable workflows to suit your existing processes
  • Customization of OOT Reports according to the organization’s templates

In addition to being an industry standard and an effective OOT Management Solution, the OOT Management System has several key features that enables organization and users to continuously improve the way OOT is handled.

Pharmaceutical OOT Management and Tracking Software Features

 Simplified OOT Reporting

OOT reporting involves a lot of description and data capture. By aligning the fields in an easy to define pattern, initiators can describe and provide all related information without entering the data manually. The system automatically routes the tasks to pre-defined roles ensuring that time involved in figuring out who to notify and how to proceed with the task is significantly minimized. This results in better OOT reporting.

Investigation Tasks

The report is investigated through a number of small tasks like re-analysis tasks, and document review. These tasks can be easily created, assigned and tracked through the system even when multiple departments are involved This brings investigators on one platform and provides organized coordination without the need for individual one-to-one meetings or discussions.

Integrated Quality Systems 

The Sample OOT Management Solution has been designed to be flexible in integrating with other quality systems. It supports the establishment of a workflow process which smoothly integrates with the rest of the quality systems especially CAPA to enable better management of the OOT. The associated CAPAs which originate from the OOT tasks can also be tracked.

Automated Alerts & Notifications 

This is a practical feature that allows users to receive automatic communications as per the defined workflow process. It intimates the required personnel about imminent target date. People responsible for the task are notified directly using e-mails which are automatically sent to their e-mail accounts. Additionally, the software automatically escalates tasks which are overdue to the respective authorities thus helping in resolving the issue.

AmpleLogic Out of Trend Software will also comply with electronic Record standards defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA and MoH

OOT Software advantages in GMP Environments

  • Pharmaceuticals
  • Biotechnology
  • Biologics
  • Medical Devices
  • Chemical
  • Contract Manufacturing
  • General Manufacturing
  • Food & Beverages