Out of Specification Software

Out of Specification Software

All test results that exceed the stipulated limits defined by the manufacturer in the drug applications and drug master files (DMFs) are included in the OOS results of the samples.

Out of Specification results gotten from the quality control laboratory regulate raw materials, branding materials, finished products, and stability samples based on criteria that are unique to the company.

This OOS Software follows authorized procedures that ensure organizations comply with established regulatory standards of authorities such as the US FDA and MHRA who monitor their Out of Specification (OOS) strategies.

The software assists in classifying the OOS by determining whether the cause is assignable or non-assignable. When the limits do not fall within the stipulated metrics, they are called out of specifications. In a situation of OOS, the analyst is expected to notify the quality control manager, and the senior manager would also demand that the analyst be sent an OOS form by the QA.

The designated quality control analyst is responsible for the categorization of the OOS. Organizations can identify and distinguish between different OOS by using unique identification numbers.

With each OOS given a number at the end of the process, AmpleLogic’s OOS Software is a very efficient tool for making this process easier.

When an OOS is initiated, the organization performs a phase-by-phase analysis to determine the root cause.

Phase 1

The first phase in the investigation is to analyze to determine if there was a laboratory error, such as:

• Dilution error of standard and sample solution
• Errors in the method of analysis
• Malfunction of the equipment
• Errors in calculation

If there is no assignable cause or error discovered during phase 1 of the investigation, then phase 2 should be initiated.

Phase 2

In this phase of the investigation, an evaluation of the manufacturing processes, sampling procedures, and other laboratory tests which may have caused the error is carried out.

Retesting and Hypothesis are two of the additional laboratory tests performed.

Retesting

• The goal of retesting is to identify mistakes that might have occurred in the process of analysis or diluting. The retesting sample must be taken from the same initial lot to ensure an accurate investigation of the cause of the error.
• If the results gotten from retesting are also outside the defined range, the batches should be re-injected, and the investigation extended to include other related batches and products.

Hypothesis

• The hypothesis involves scrutinizing a specimen from any supplementary units collected as part of the original sampling or from a new sample taken from the same batch.
• Errors that occur as a result of an incorrect hypothesis serve to validate the original hypothesis. This makes it necessary for the organization to come up with a new procedure.

OOS Extension

• We will close the investigation if we discover the meaning or a fixable error in any of the aforementioned steps.
• If no correctable errors are found in either of the two phases, an OOS extension will be issued to repeat the earlier steps.

It is quite stressful and time-consuming to record and track information in OOS logs manually. The LOW CODE NO CODE (LCNC) PLATFORM is used to develop this Amplelogic OOS Software which can be used locally or in the cloud. As a web-based solution, it can be accessed from any device, including smartphones, tablets, and desktop computers.

This OOS Software not only provides the most effective strategy for OOS closure, but it is also totally compliant with electronic records and management regulations such as 21 CFR Part 11. In compliance with the regulatory standards and policies guiding the organization, the program provides correct audit trails, e-signatures, printing information, controlled access, records management, and record archiving.

The OOS Management Software System aids organizations in smoothly switching from their existing OOS handling processes as it is relatively simple to integrate the software into their existing environment in a short period.

Users can easily generate summary and metric reports with a single click as a result of its holistic tracking and trending features.

From the initial reporting to batch release, AmpleLogic’s Out of Specification Management Software automates the process of managing raw materials or finished products. It also includes rejection procedures that are constituted by phase-by-phase investigations and the identification of related CAPAs before closure.