Out of Specification

Out of Specification Software

The OOS results of the Samples include all test results that fall outside the specified Limits defined by the manufacturer in the drug applications, drug master files (DMFs).

The Out of specification Results obtained in the Quality control Laboratory govern raw materials, packaging materials,, finished products, and stability samples according to company-specific parameters

Regulatory authorities like US FDA and MHRA audit an organization’s Out of Specification (OOS) techniques to ensure compliance with set standards and procedures. The OOS process adheres to an approved methodology that the organization is required to follow.

The software helps in categorizing the OOS by identifying the cause as assignable or non-assignable. When the limits are not under specified measures, then they are called out of specifications. In the event of an OOS, the analyst must inform the QC manager. Consequently, the senior manager requests QA to issue an OOS form to the analyst.

The classification of the OOS fall on the shoulders of the designated QC Analyst Organizations can distinguish between different OOS with the help of the unique identification number.

AmpleLogic’s OOS Management Software  is a reliable tool that is used to facilitate this procedure.. A unique number is assigned to each OOS at the end of the process

Once an OOS is initiated, the organization conducts a phase-wise analysis to identify the root cause.

Phase 1

As part of Phase 1 investigation, an analysis is carried out to identify any error that may have occurred in the laboratory such as

  • Dilution error of standard and sample solution.
  • Errors in analysis method
  • Equipment malfunction
  • Errors in calculation

If no assignable cause or error is identified in phase I investigation, then phase II investigation has to be started

Phase 2

This phase of investigation involves an analysis of the manufacturing processes, sampling procedures and other additional laboratory tests which could have caused the error.

These additional laboratory tests include Retesting and Hypothesis


  • Its main objective is to determine analytical or dilution error. To correctly investigate the cause of the error, the retesting sample must be taken from the same initial lot.
  • If the results from retesting are also out of specified limits, then the batches should be re-injected and the investigation should be expanded further to other associate batches and products


  • Hypothesis involves analyzing a specimen from any additional units collected as part of the original sampling or from a new sample collected from the same batch.
  • Errors which occur because of improper hypothesis, validate the hypothesis. This requires the organization to propose and document a new procedure.

OOS Extension

  • If we find the meaning or correctable error in any of the above steps we will close the investigation
  • When there are no correctable errors identified in either of the two phases then an OOS extension will be taken in order to conduct the above steps once again

Manually recording and tracking the information in OOS Logs is tedious and time consuming.  Amplelogic OOS Software is developed on LOW CODE PLATFORM. This Software can be installed on Premise or can be offered as a Cloud service. A completely web based solution, can be accessed from the Mobile, Tabs or Desktops.

Besides providing the best approach for effective closure of OOS, The OOS Software is in fully compliant with electronic records and management regulations such as 21 CFR Part 11. It provides accurate audit trails, e-signatures, printing information, controlled access, records management as well as archiving of the records. This is in adherence with regulatory standards and policies followed by the organization.

The OOS Management Software System supports organizations in easily transitioning from current OOS handling processes. Organizations find it relatively easily to integrate the software into the existing environment in a short time.  

The comprehensive tracking and trending features allow users to easily generate summary and metric reports in one click.

AmpleLogic Out of Specification Management Software automates the process of handling raw materials or finished products from initial reporting to batch release. It also includes rejection procedures which involve phase-wise investigations and identification of associated CAPAs before closure.

Key Features of Laboratory OOS Automation Software 

Simplified OOS Reporting

The reporting features include data capturing. This enables easy description of the OOS by initiators by merely aligning the fields in a well-defined pattern.

It provides substantial information without manual data entry as everything on it, is automated. This feature contains automatic routing that allows OOS reporting to be shared with, and vetted by pre-defined experts like lab supervisors. With this feature, issues are corrected on time and errors are drastically reduced.

Phase wise Investigation

When an OOS is reported, it is subjected to investigation with the aid of this feature. All tasks are analyzed, tested and sample again to ensure compliance with necessary policies, standards and regulations.

Investigation is concluded through a series of tasks. These include a review of the document, re-testing and re-sampling. The software allows for easy creation, assignment and tracking of the tasks to monitor completion across different departments.

Investigators are brought under one platform and communicate better with each other even when they are apart.

Integrated Quality Systems

AmpleLogic Out of Specification Management System makes it possible for organizations to integrate the software program with existing or new quality systems. This improves the flow of information to and from the OOS Management System and other quality systems especially CAPA.

All CAPAs are managed through the CAPA Management system which provides status tracking to the OOS Management system.

Automated Alerts & Notifications

This feature supports the organization in maintaining clarity about existing OOS through automatic communications and notifications shared by the system according to pre-defined workflow steps. These notifications alert users on approaching target date for a specific set of actions.

Notifications reach the users in the form of direct e-mail sent to the user’s e-mail account.

Additionally, the software automatically escalates overdue tasks to keep key personnel informed about it and to accelerate the process of issue resolution.

Reports and Dashboards

Summary Report gives real-time information within the selected OOS and metrics reports. It provides in-depth performance visibility of a Quality System across the organization at any given point.

Benefits of Out of Specification Software for Biotech, Pharmaceutical and Life Sciences Companies

  • In addition to providing the best approach for effective closure of OOS by following CGMP standards, The OOS Software is in full compliance with electronic records and management regulations such as 21 CFR Part 11, by providing complete audit trails, e-signatures, controlled access, and printing, records management and archival in accordance to regulatory standards and policies of an organization.
  • Guarantees 24 x 7 accessibility because it is web-based
  • Consists of some of the most distinctive workflows and better closure timelines than paper-based techniques.
  • Improves compliance and ensures product conformance. As a result, customer complaints or market complaints related to the product can be minimized. It also reduces deviations from the actual specifications of the product.
  • Allows organizations to stay updated on an ongoing OOS issue by easily tracking it and by receiving notifications and instant alerts which relay its current status.
  • Product quality and safety of the product can be guaranteed during the shipment. It also accelerates the process.
  • When complaints are initiated, solutions are identified and patterned to suit your reports.
  • Ensures fluidity and easy integration with other systems like CAPA.
  • It is accurate and allows for data capturing too.
  • The second phase is automatically triggered by the software based on the outcome of the first phase.

AmpleLogic Out of Specification 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

Other Industries that can benefit from AmpleLogic OOS Management Software System

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

Kindly contact us for more information about how your organization can benefit from AmpleLogic OOS Solution