Out of Specification

Out of Specification OOS Record Management and Tracking

Raw Material Testing sometimes results in an out-of-specification. This forms an OOS which needs to be reported and investigated as recommended by the guidance from Regulatory Authorities. Often the manufacturing priorities and the amount of time required for Re-testing and Re-sampling, weaken the investigation leaving scope for unidentified true root cause and repeated OOS that can lead to a major product failure. With time factor being crucial and to overcome un-negotiable priorities, automated Out of Specification (OOS) Management Software is a needy tool to accelerate investigations and conclude thoroughly.

OOS Management Software Solution

This OOS Management System automates the process of handling Out-of-Specifications for raw materials or finished products from initial reporting to batch rejection or release through phase wise investigations and any associated CAPA before closure. This enables an organization to reduce OOS reporting time, evaluate for its repetition with ease of access to previous records/ summary reports and disintegrate investigation into multiple tasks such as Re-analysis tasks, re-sampling 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 OOS closure timelines with overdue controls and auto escalations.

With configurable workflows and flexible workflow components/ sections it is easy for the OOS Management solution to be transitioned into your current OOS handling process within in a short period. Comprehensive OOS Tracking and Trending is made available at the click of a button with Summary Reports and Metrics Reports. OOS Summary Report gives real-time summarized information within the selected OOS and metrics reports bring high-level and in-depth performance visibility of the Quality System across the organization at any given point.

Besides providing best approach for effective closure of OOS , the OOS 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 OOS Management Advantage

This OOS Management Software solution was developed based on extensive research on OOS guidelines from various regulatory agencies, and to be practical and problem oriented with these core benefits:

  • Enterprise wide 24 x 7 accessibility to OOS Management Software that allows OOS reporting real-time as they happen.
  • 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 OOSs with status, automated alerts and notifications.
  • Improved OOS 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 OOS Reports according to OOS 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 OOS Management solution, the OOS Management system has several key features that enable organization and users to continuously improve the way OOS is handled

Key Features of OOS Management

Simplified OOS Reporting
OOS reporting involves a lot of description and data capture. By aligning the fields in an easy to define pattern, initiators can describe an OOS and provide all related information without much of manual data entry. Automated routing to pre-defined individuals such as lab supervisors ensures that the time involved in figuring out who to notify and how to respond is drastically reduced resulting in an optimized and simplified OOS reporting.

Phase wise Investigation
The reported OOS is investigated in first phase through re-analysis tasks assigned to initiator and concluded for assignable cause. A non-assignable cause automatically triggers second phase investigation across cross functional departments. Further the investigation is concluded through series tasks such as document review, re-sampling and re-testing 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 OOS Management system is designed to be flexible in integrating with other quality systems and establish a seamless and controlled workflow between OOS management System 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 OOS 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.

You can feel free to reach us to know more about AmpleLogic OOS Management System and get your questions answered.

Industries that can benefit from our Solution

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