Out of Specification (OOS) Software

Streamline your out-of-specification (OOS) laboratory result investigations by ensuring consistent OOS result intake, root cause identification, follow-ups, and resolutions.

OOS CAPA Report in SimplerQMS


What’s in SimplerQMS’s Out of Specification (OOS) Software?

SimplerQMS provides a cloud-based quality management software for life sciences with a built-in OOS software solution that helps laboratories to manage OOS investigations from start to finish. Here are some of the main Out of Specification software features and benefits you get by using SimplerQMS.

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Simplify Document Review and Approval Processes

Capture, investigation, and addressing an OOS result requires a series of documentation activities which are time-consuming and manually laborious.

SimplerQMS provides a streamlined way for authorized personnel to review and approve documents within a familiar Microsoft Office environment. With our OOS software, you can quickly create, review, and approve documents related to your incidents, such as protocols, SOPs, and work instructions.

Furthermore, email alerts, notifications, and escalation of assignments to managers are just some of the features that will help resolve issues quickly.

Easily Initiate NCs or CAPAs, When Necessary

Not every OOS requires a CAPA or an NC, but sometimes OOS results can be a sign of a bigger problem, and corrective action and preventive action (CAPA) or NC might be required.

SimplerQMS allows you to push any quality issue, including, OOS results to your non-conformance or CAPA process by starting a form directly from the out-of-specification product or incident response effort, reducing human error, and ensuring complete data.

OOS CAPA Report Form in SimplerQMS

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OOS CAPA Report Relations in SimplerQMS

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Connect Quality Processes Across the Entire Organization

OOS incidents can have a ripple effect across the entire organization, so it’s important to be able to quickly connect investigations with other quality processes, such as change management, non-conformance, CAPA, and others.

SimplerQMS makes it easy to see how an issue is connected to other quality processes with its built-in linking feature. All documents can be linked to each other and are stored in a secure, centralized cloud-based storage location for easy access and retrieval.

Ensure Compliant OOS and OOT Management Process

When it comes to Out of Specification (OOS) and Out of Trend (OOT) lab results, you need to have streamlined processes for documentation and investigation in place to ensure compliance with cGMP, 21 CFR Part 210, and 21 CFR Part 211.

With our Out of Specification solution, you can be confident that your OOS and OOT investigations are being conducted in a compliant manner, and ensure 100% audit readiness. Furthermore, SimplerQMS provides time-stamped audit trails, document versioning, and electronic signatures which are 21 CFR Part 11 and GxP compliant so you can be sure your records will stand up to scrutiny.

OOS Document Audit Trail in SimplerQMS

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eQMS That Goes Beyond OOS Process Management


Track and manage nonconformances throughout the organization, from initial identification to final resolution.

CAPA Management

Automate and accelerate CAPA processes while ensuring regulatory compliance with CAPA management requirements.

Change Management

Ensure that all changes are properly documented, reviewed, and approved before being implemented.

Equipment Calibration

Track and manage your equipment calibration schedule, assign tasks, and track their progress with ease.

Supplier Management

Streamline the process of collecting supplier-related information, maintaining records, and managing supplier performance.

Audit Management

Simplify tasks related to auditing – scheduling audits, maintaining records of audit findings, preparing for audits, and more.

Frequently Asked Questions

What is Out of Specification (OOS) Software?

OOS software provides features and support for consistent identification and management of OOS results within the context of a quality management system (QMS).

As per requirements set forth by cGMPs, FDA, MHRA, Annex 11, and others, manufacturers must ensure that the product follows pre-defined specifications. In cases when a product is out of specification, an organization has to investigate and document the results.

The software solution helps establish a workflow to manage OOS results, allowing you to identify, document, evaluate, investigate, and resolve issues. As a result, this helps decrease cycle times, and operational costs, and promotes continuous improvements while meeting product quality specifications.

Why is Out of Specification Software Important?

Out-of-specification events can have a ripple effect across the organization and can lead to product recalls, loss of market share, and damage to reputation. To avoid such negative consequences, it is important to have a streamlined process in place for the identification and management of OOS issues.

They can be challenging to manage, but with the help of the Out of Specification software solution, you can streamline the process. The software helps you ensure consistent intake of OOS results, identify the root cause quickly and efficiently, and follow up on resolutions.

As a result, you can avoid costly mistakes, and keep your product quality up to par.

What makes SimplerQMS OOS Management Tools Popular?

These are a few reasons that make SimplerQMS software popular:

  • Automated workflows: Automate the documentation and investigation process from start to finish to ensure consistency and compliance.
  • Document linking: Link OOS investigations with other quality processes such as change management, non-conformance, and CAPA to get a holistic view of product quality.
  • Centralized cloud-based storage: Keep all your documents in one secure, location for easy access and retrieval.
  • 21 CFR Part 11 compliance: SimplerQMS is designed to meet the US FDA’s requirements for the acceptance of electronic records and electronic signatures.
  • Best-practice forms: Utilize our best-practice forms and templates to save time and ensure compliance, or use your own forms and templates.
  • Microsoft Office integration: Our software integrates with Microsoft Office products such as Word and Excel for easy document creation and editing.

How Much Does OOS Software Cost?

Out of Specification software by SimplerQMS is a part of an all-inclusive Quality Management Solution. This means that the price you pay includes all system modules, implementation, training, support, validation, and more.

The price of the software depends on how many people will use it. You can book a demo to talk to our experts and get a pricing quote for your needs.

Ready to learn more?

To learn how your life science organization can make the most of SimplerQMS, request a personalized demo.

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