Life Sciences Companies generate a huge amount of information from Chemical, Microbial and Physical analysis for the raw materials and finished products. This valuable information can be trended to forecast and revise the alerts and actions limits for quality specifications. But a variance or aberrant trends in comparison to previous history, results in an Out-of Trend which needs to be investigated. The challenge with manual OOT Management systems is to have a well-organized, fast paced investigation structure, easily accessible information and with good traceability. These challenges push the need for an automated OOT Management Software that can easily manage OOTs with effective fast track investigations and enhanced communications.
Our OOT Management Software Solution
The AmpleLogic This OOT Management Software allows the Quality Unit of an Organization to manage OOTs, from initial reporting through failure investigations, implementation of any associated CAPA and closure on an automated and streamlined platform. This enables an organization to reduce OOT reporting time, evaluate for its repetition with ease of access to previous trends/ summary reports and further disintegrate investigation into multiple tasks such as Re-analysis tasks, review tasks that can be assigned, completed and tracked. Post investigation, initiate any associated corrective/ preventive actions and implement with effectiveness checks at integrated CAPA Management System. And ultimately improve OOT closure timelines with overdue controls and auto escalations.
OOT Management Software to be transitioned into your current process within in a short period. Comprehensive OOT Tracking and Trending is made available at the click of a button with Summary Reports and Metrics Reports. OOT Summary Report gives real-time summarized information within the selected OOT and metrics reports bring high-level and in-depth performance visibility of closure of OOT across the organization at any given point.
Besides providing best approach for effective closure of OOT , the OOT Management Software is in total compliance with electronic records and management regulations such as 21 CFR Part 11, by providing audit trails, e-signatures, controlled printing, controlled access, records management and archival in accordance to regulatory standards and policies of an Organization.
AmpleLogic OOT Management Advantage
AmpleLogic This OOT Management Software solution was developed based on extensive research on 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
- Total compliance with 21 CFR part 11
- Harmonization and Accuracy in initial data capture through logical business rules applied to fields such as rounding off results to two decimals
- Fast-track investigations prevent customer shipment delays and ensure product quality/ safety
- Automated triggering of second phase investigation based upon conclusion of first phase
- Live tracking and traceability of OOTs with status, automated alerts and notifications
- Improved OOT Closure timelines with best practiced workflows
- Capabilities to easily integrate and establish closed-looping with other Quality Systems such as CAPA
- Customizable workflows to suit your current process
- Customizable OOT Reports according to OOT templates of the company
- Metrics Reports or Trends that are exclusively analytical and visually eye catching
Apart from being an industry standard and an effective OOT Management solution, the OOT Management system has several key features that enable organization and users to continuously improve the way OOT is handled.
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 an OOT 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 reported OOT is investigated through series of tasks such as document review, re-analysis tasks that can be created, assigned, tracked for completion across different departments. This brings investigators across one platform and provides organized coordination without the need of individual one-to-one meetings or discussions.
Integrated Quality Systems
The OOT Management Software is designed to be flexible in integrating with other quality systems and establish a seamless and controlled workflow between OOT management and rest of the quality systems specially CAPA Management. The CAPAs originating can be initiated and closed at the CAPA Management with enabled status tracking at the OOT Management.
Automated Alerts & Notifications
This is practical feature that ensures that the users are automatically communicated at defined frequencies and at defined workflow steps about the approaching target date for required actions. Users are notified directly through follow-up e-mails that are sent automatically to the user e-mail account. Besides the system auto escalates the overdue to the concerned authority and help resolve the issue.
Industries that can benefit from our Solution
- Medical Devices
- Contract Manufacturing
- General Manufacturing
- Food & Beverages