Out of Specification

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 program 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 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.

Important Features of Laboratory OOS Automation Software 

Simplified OOS Reporting

One of the features of reporting is data capturing. This makes it simple for initiators to describe the OOS by simply aligning the fields according to a predetermined pattern.

It provides a wealth of information without the need for manual data entry because everything on it is automated. This feature includes automatic routing, which enables OOS reporting to be shared with and inspected by specified experts such as lab supervisors. Issues are rectified in real-time, and errors are significantly reduced due to this feature.

Phase wise Investigation

On reporting an OOS, an investigation is launched by using this feature. All tasks are evaluated, assessed, and sampled a second time to make sure that they comply with all policies, standards, and regulations.

A series of tasks such as a review of the document, re-testing, and re-sampling is needed to complete the investigation. The software makes it easy to create, designate, and monitor tasks across different departments.

Investigators are unified on a single platform, and they are able to communicate more effectively even when they are not together.

Integrated Quality Systems

Organizations can integrate AmpleLogic’s Out of Specification Management software with other new or existing quality systems. This improves on how information is passed between the OOS Management System and the other quality systems like CAPA.

The CAPA Management System which helps the OOS Management System with status tracking is used for managing all CAPAs.

Automated Alerts & Notifications

With the help of automatic communications and notifications shared by the system, this feature helps the organization stay abreast of the current OOS. These notifications let users know when the due date for a particular set of tasks is drawing near.

These notifications are delivered to users through direct email to the user’s inbox. Besides that, the software automatically escalates overdue tasks to ensure that the personnel in charge are informed, and speed up the issue resolution process.

Reports and Dashboards

The Summary Report contains up-to-date data from the selected OOS and metrics reports. It provides detailed performance visibility of a Quality System across the organization at any point in time.

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

  • The OOS Software is fully compliant with electronic records and management regulations such as 21 CFR Part 11 and provides complete audit trails, e-signatures, controlled access, and printing, records management, and archival in full compliance with regulatory requirements and policies of an organization in addition to following CGMP standards for effective closure of OOS.
  • Guarantees 24 x 7 accessibility because it is web-based
  • Compared to traditional paper-based methods, it has more distinctive workflows and faster timelines for project completion.
  • It enhances compliance while also ensuring that the final product is in conformance. This helps to reduce complaints from the customer or market. It also helps to minimize product deviations from the original specifications.
  • It keeps organizations informed about current OOS issues by closely monitoring it, and through notifications and prompt alerts about their current status.
  • During shipment, the product’s quality and safety remain uncompromised.  It also quickens the process.
  • When a complaint is filed, solutions are identified and tailored to your reports
  • Ensures smooth operation and easy integration with other systems such as CAPA
  • It is precise, credible, and also allows for data capture
  • The software automatically initiates the second phase based on the results of the first

AmpleLogic Out of Specification Software will also meet electronic record standards set by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH.

AmpleLogic OOS Management Software System can also be used in other industries such as:

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

To learn more about how AmpleLogic OOS Solution can benefit your company, please do well to contact us