OOT – Out of Trend
Life Sciences Companies generates a large amount of information data from Chemical, Microbial and Physical analysis for the raw materials and finished products. This valuable information will be tended to forecast and revise the alerts and action limits for quality specifications. But a variance or aberrant trends in comparison to the previous history results in an Out of Trend that needs to be investigated. The challenges with manual process OOT Management System is to have a well-organized, easily accessible information, fast-paced investigation process, and with traceability. Therefore, these challenges push the need for an automated OOT Management Software which can easily manage, effective fast track investigations and enhanced communications.
Out of Trend is used by drug manufacturers to ensure that drug products are produced within the defined specifications. Whenever the drug or product is not meeting the specified standards then it leads to a result of Out of Trend. As per the FDA guidelines the most important thing that quality issues are to be effectively resolved after phase wise investigation, CAPA or Change Control and Root Cause Analysis.
AmpleLogic offers electronic record management for records with an ability to store and retrieve all relevant documents based on organization need. Out of Trend Software will ensure compliance with FDA 21 CFR Part 11, EU Annex 11, cGMP, GMP (Goods Manufacturing Practices) and other best practices, etc.
AmpleLogic OOT Management Solution
This Software allows the Quality Unit of an Organization to manage and from initial reporting through a failure investigation, implementation of any associated CAPA and closure on an automated and streamlined platform. This enables the organization to reduce reporting time, evaluate for its repetition with ease of access to previous summary reports or trends and further disintegrate investigation into multiple tasks such as Review Tasks, Re-Analysis tasks, which can be assigned, completed and tracked. In Post investigation, initiate any associated corrective/ preventive actions and implement with effectiveness checks at integrated CAPA Management System. Therefore, it can improve, closure timelines with overdue controls and auto escalations.
Our Solution is to be transitioned into your current process within a short period. This Comprehensive Tracking and Trending will automatically generate Metric Reports and summarized Reports with a click of a button. The Summary Report gives you real-time summarized information within the selected OOT and metrics reports which will give high-level and in-depth performance visibility of closure of OOT across the organization at any given point of time.
Besides providing the best approach for effective closure of OOT. It is in total compliance with electronic records and management regulations such as 21 CFR Part 11, by providing detailed audit trails, electronic signatures, controlled printing, and access, records management and archival in accordance to policies and regulatory standards of an Organization.
Advantage of AmpleLogic OOT Management
IT has been developed based on extensive research on out of trend guidelines from various regulatory agencies, and to be practical and problem-oriented with these core benefits:
- Enterprise-wide 24 x 7 accessibility that allows optimized OOT reporting anytime and coordinates failure investigations effectively
- Out of Trend solution will comply with Pharmaceutical and Biotech Industry regulations i.e. 21 CFR Part 11 requirements, EU Annexure 11, cGMP and GMP (Goods Manufacturing Practice), etc
- Harmonization and Accuracy in initial data capture through business logic applied to 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 best-practiced workflows
- Easily integrates and establish closed-looping with other Quality Systems such as CAPA
- Customizable workflows to suit your current existing process
- Able to Customize OOT Reports according to their templates of the company
Apart from being an industry standard and an effective OOT Management Solution and OOT Management System have several key features that enable organization and users to continuously improve the way OOT is handled.
Key Features of OOT Management Solution
Simplified OOT Reporting
OOT reporting involves a lot of description and data capture. By aligning the fields in an easy to define a pattern, initiators can describe and provide all related information without much of manual data entry. Automated routing to pre-defined roles ensures that the time involved in figuring out who to notify and how to respond is drastically reduced resulting in an optimized and simplified OOT reporting.
The report is investigated through a series of tasks such as re-analysis tasks, document review that can be created, assigned, tracked for completion across multiple departments. This brings investigators across one platform and provides organized coordination without the need for individual one-to-one meetings or discussions.
Integrated Quality Systems
The OOT Management Solution has been designed to be flexible in integrating with other quality systems and establish a seamless and controlled workflow process between OOT Management and the rest of the quality systems specially CAPA Management. The CAPA’s originating can be initiated and closed with an enabled status of tracking.
Automated Alerts & Notifications
This is a practical feature that ensures the users are automatically communicated at defined frequencies and at a defined workflow process about the approaching target date for required actions. Users are notified directly through follow-up e-mails that are automatically sent to user e-mail accounts. Besides the system auto escalates the overdue to the concerned authority and thus helps in resolving the issue.
Industries that can benefit from our Solution
- Medical Devices
- Contract Manufacturing
- General Manufacturing
- Food & Beverages