OOS – Out of Specification

It is very pertinent for specifications set by regulatory bodies be followed to the later. Out of Specifications(OOS) techniques are keenly investigated and checked by regulatory authorities to ensure that set standards and due process is followed.  This term is used to describe those results in process or finished product testing, this process follows a specified and approved methodology that must be adhered strictly to.

The OOS arises when there are deviations in the product manufacturing process, errors that may arise in testing procedures, or due to malfunctioning of analytical equipment. It allows for the proper investigation of a particular root cause analysis for that OOS.

The reasons for OOS can be classified under either assignable or non-assignable categories. When the limits are not under specified measures, called out of specifications. When OOS has occurred, QC manager should be informed by the respective analyst. Then the senior manager will communicate with QA for OOS form issuance to analyst.

The designated employee will classify the OOS as either assignable cause or non-assignable cause. Each out of specification will be identified with the help of unique identification number.

An automated OOS Management Software however, is a dependable tool that is used to facilitate this process and used to effectively classify the OOS as either assignable cause or non-assignable cause. An identification number is administered to each OOS at the end of the process

When an OOS Has been identified, a phase wise root cause analysis has to be initiated to find out the cause for OOS.

Phase 1

As part of Phase 1 investigation to identify any error occurred in laboratory such as

  • Errors in analysis method

  • Equipment malfunction

  • Errors in calculation

  • Dilution error of standard and sample solution.

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

Phase 2

In phase II investigation, we should look for the error in manufacturing processes, sampling procedures and other additional laboratory tests.

These additional laboratory tests include Retesting and Hypothesis.


• Its main objective is to determine the analytical or dilution error. This 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.

  • If the error is due to improper hypothesis, then the hypothesis is validated, and new procedure should be proposed and documented.

OOS extension

• If we find the meaning or correctable error in any of the above steps we will close the investigation

• If we Do not find proper correctable error in both the phase I and Phase II then OOS extension should be taken to re conduct the above steps.

OOS Record Management Software Solution

Out of Specification Management System automates the process of handling with raw materials or finished products from initial reporting to batch release or rejection through phase wise investigations and with any associated CAPA before closure. This enables the organization to reduce their OOS reporting time, evaluate for its repetition with ease of access to its records/ reports and disintegrate investigation into multiple tasks such as Re-Sampling, Re-Analysis tasks, Review tasks that can be assigned, completed or tracked. During Post investigation, initiate any associated corrective action/ preventive actions and implement with effectiveness checks at an integrated CAPA Management System. Therefore it will improve OOS closure timelines with overdue controls as well as auto escalations.

With flexible and configurable workflows, it is easy for the OOS Management Solution to be transitioned into your current OOS handling process within a short period of time. This Comprehensive Tracking and Trending will automatically generate Summary Reports and Metrics Reports with a click of a button. This Summary Report gives real-time information within the selected OOS and metrics reports will give you in-depth performance visibility of a Quality System across the organization at any given point.

Besides providing the best approach for effective closure of OOS and Management 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.

Benefits of Infotronicx Pharmasol Out of Specification Management

Infotronicx Pharmasol OOS Management has been developed carefully with the aid of extensive research carried out based on the OOS principles laid down by regulatory bodies.

This management solution provides users with diverse benefits including:

  • Guarantees 24 x 7 accessibility because it is web-based

  • Developed and researched painstakingly in compliance with pharmaceutical and Biotech Industry regulations i.e. 21 CFR Part 11, EU Annex 11, cGMP and GMP (Goods

  • Manufacturing Practice), etc.

  • Consists of some of the most distinctive workflows and better closure timelines than paper based.

  • This facilitates products conformance and hence, the customer or market complaints on products is reduced drastically. Deviations from actual specifications is minimized too.

  • OOS can be tracked effectively with its life tracking system and facilitates communications with automated and instant alerts or notifications.

  • Product quality and safety during shipment is guaranteed and swiftly carried out without delays.

  • When complaints are made, solutions are made 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.

  • Auto triggering of second phase investigation based upon the conclusion of the first

Infotronicx Pharmasol Out of Specification Management Solution has several key features that enable the organization and as well as users to continuously improve the way OOS is handled

Key Features of Out of Specification Management

Simplified OOS Reporting

The reporting involves an effective description feature that also includes data capturing. This enables easy description of the OSS 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 distributed to pre-defined experts such as lab supervisors for vetting. With this feature, issues are corrected on time and errors are drastically reduced.

Phase wise Investigation

When the OOS is reported finally, it is subjected to further investigation with the aid of this feature. Tasks brought here are re-analyzed, re-testing, re-sampling and crosschecked for compliance with regulatory bodies.

Investigation is concluded through a series of tasks such as document review, re-testing and re-sampling tasks that can be created, assigned, tracked for completion across different departments.

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

Integrated Quality Systems

Infotronicx Pharmasol Out of Specification Management System is designed to be flexible in integrating with other quality systems and establish a seamless, controlled workflow between OOS Management System and with rest of quality systems specially CAPA Management.

The CAPAs originating can be initiated and closed at CAPA Management with enabled status tracking at OOS Management.

Automated Alerts & Notifications

This is a practical feature that ensures 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.