Out of Trend

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 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.

OOT Management Solution for Quality Control Laboratories

The Sample OOT Management Software enables an organization’s Quality Unit to manage an OOT through an automated and simplified process, from first reporting of Sample information to conduct a failure investigation, to applying any related CAPAs, and finally closing the OOT.

This reduces reporting time, allows analysis of the work for duplication, and makes prior summary reports or trends easily accessible. Once all of these tasks have been completed, they may be allocated, accomplished, and monitored. The post-investigation procedure entails the implementation of a CAPA, and it starts with the creation of an investigation request. Following this, the CAPA management System requires effectiveness checks to be performed. The implementation of this system allows for alerts, auto escalations, and system integration to minimize closing time.

Amplelogic Sample OOT Tracking Software will be quickly integrated into your environment, and you’ll be able to put it into use quickly. Automating the creation of metric reports and summary Reports of each sample with a press of a button will be possible with the use of this complete tracking and trending system.

The Summary Report provides real-time summaries of the data included inside a particular OOT and associated metrics reports. It enables improved visibility and traceability of the OOT at all times.

Along with offering the optimal strategy for successful OOT closure, the program complies with all applicable electronic records and management standards, such as 21 CFR part 11. The software does this by providing organizations with comprehensive audit trails, electronic signatures, restricted access, comprehensive records management, and control printing and archiving in line with the organization’s rules and regulatory standards.

Advantage of Out of Trends Automation 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:

  • Any authorized personnel around in the organization have instant access to the program 24/7, which assists in efficiently organizing failure investigations
  • The Out of Trend solution will adhere to all applicable laws in the Pharmaceutical and Biotechnology industries. These include 21CFR Part 11, EU Annexure 11, and cGMP and GMP (Good Manufacturing Practices) rules, among others
  • Harmonization and accuracy in initial data capture are achieved by the application of business logic to areas, such as rounding values to two decimals
  • Its rapid-response investigations eliminate customer shipment delays and make sure of product quality and safety
  • The second phase of the investigation is initiated automatically after the completion of the first phase
  • It enables real-time monitoring and tracing of status, as well as automatic email alerts and notifications
  • Improved OOT closure times with the use of best practices-based processes
  • Integrates easily and creates closed-loop control with other quality systems, such as CAPA
  • Workflows that are configurable to fit your present procedures
  • The ability to customize OOT reports to meet an organization’s template

Apart from conforming with industry standards, and being an efficient OOT Management Solution, the OOT Management System has several essential features that enable organizations and individuals to constantly enhance the way OOT is managed.

Features of Pharmaceutical OOT Management and Tracking Software 

 Simplified OOT Reporting

OOT reporting entails a great deal of description and data collection. Initiators can describe and give the necessary information without having to manually input the data by arranging the fields in a simple-to-define pattern. The time spent determining who to notify and how to proceed with the work is minimized since the system automatically forwards the task to pre-defined roles. As a result, the OOT reporting becomes more accurate.

Investigation Tasks

The report is scrutinized by a series of minor tasks, such as re-analysis and document review. Even when many departments are involved, these tasks can be readily created, allocated, and monitored through the system. This unifies investigators on one platform and eliminates the need for separate meetings or conversations.

Integrated Quality Systems 

The Sample OOT Management Solution is designed to integrate easily with other quality management systems. It assists in the creation of a workflow process that interacts seamlessly with the rest of the quality systems, particularly CAPA, to improve OOT management. CAPAs linked with OOT operations can also be monitored.

Automated Alerts & Notifications 

This is a useful feature that makes it easy for users to follow established workflow processes by sending automated communications to them. It notifies the appropriate personnel of the coming goal date. Individuals assigned to the job are alerted immediately via e-mails delivered to their e-mail accounts. The software is also programmed to escalate outstanding tasks to the relevant authorities, helping to remedy the problem.

Additionally, AmpleLogic’s Out of Trend Software complies with electronic record requirements prescribed by the TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH.

Additionally, the following industries can also benefit from AmpleLogic’s Out of Trend Software:

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