Out of Specification (OOS) Management
Capture, investigate, and document out-of-specification results to support timely resolution and compliance.
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What are SimplerQMS Out of Specification (OOS) Management Capabilities?
SimplerQMS provides a cloud-based quality management software for life sciences with OOS management capabilities that help laboratories manage OOS investigations from start to finish. Here are some of the main Out of Specification management features and benefits you get by using SimplerQMS.
Simplify Document Review and Approval Processes
Capturing, investigating, and addressing an OOS result requires a series of documentation activities that 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 SimplerQMS, 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, or 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.
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 Processes
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 management capabilities, 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.
eQMS That Goes Far Beyond OOS Management
Frequently Asked Questions
QMS software with OOS management supports and ensures 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 must investigate and document the results.
The QMS 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.
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.
OOS issues can be challenging to manage, but with the help of comprehensive QMS software, you can streamline the process of Out of Specification management. The QMS software helps you ensure consistent handling 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.
These are a few reasons that make SimplerQMS 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: SimplerQMS integrates with Microsoft Office products such as Word and Excel for easy document creation and editing.
Out-of-specification management is part of the all-inclusive quality management software by SimplerQMS. This means that the license fee you pay includes all QMS 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.
