Deviation Management Software for Life Sciences

Enhance investigation, documentation, and resolution of deviations through a streamlined deviation management process.

Deviation List in SimplerQMS (Laptop)


Comprehensive Deviation Management Software Within a Complete eQMS

SimplerQMS deviation management software helps Life Science companies simplify the handling of deviations.

The system enables users to create deviation documents using templates, route documents for review, update or approval, escalate deviation to a CAPA, relate relevant documents to ensure traceability, sign documents with electronic signatures, and more.

SimplerQMS deviation management module is an integral part of a complete eQMS software, which includes all Life Science QMS modules, such as document control, change management, training management, CAPA management, vendor management, audit management, and other quality processes.

Editing Deviation in Microsoft Word

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Create and Handle Deviation Documents

Create deviation documents in Microsoft Word using templates from our complementary document template package based on Life Science requirements. You can customize our forms and templates or use your own document templates in SimplerQMS.

Use pre-configured workflows to follow important steps required to achieve compliance regarding deviation management, such as assigning an Issue Handler, routing documents to review before approval, and so on.

Assign Deviation-Related Tasks

Easily assign relevant persons to specific tasks when drafting documents. For instance, assign the Issue Handler and the responsibility of escalating deviations to the CAPA process.

Create assignments and define timelines to receive automatic notifications regarding required actions before the due dates.

Route documents for review, update, or approval while the system automatically records all actions to ensure full traceability.

Email Notification Regarding Deviation Assignment

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Deviation List in SimplerQMS

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Keep Track of All Deviation-Related Data

Store all documents in a single cloud-based system for secure and easy access from anywhere.

Relate deviation documents to products, manufacturing, and vendors to keep track of related data points and help you investigate the root cause of the issue.

Create supplier deviation requests and share them directly from inside the system with your vendors.

Upload deviation evidence files into the system using a drag-and-drop feature. Any document format can be uploaded, such as Word documents, Excel tables, PowerPoint slides, PDFs, images, and more.

Monitor the Status of Deviations

Monitor deviation status using customizable views to keep track of the current status and be aware of the next steps.

Access a complete document history to see when, why, and who made changes to each document deviation record.

Export data to further analyze deviation-related KPIs, such as the number of deviations in a given period, deviations by risk level, the number of deviations that escalated to a CAPA process, and so on.

Deviation and Related CAPA in SimplerQMS

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Illustration of Integrated QMS Processes

Interlink All Quality Management Processes

Manage all quality processes in one system. From document control to deviation and CAPA management to supplier management, to change control and training management and other processes. All Life Science QMS modules are included and interlinked in a complete eQMS solution.

Link deviations to risk assessments and perform a risk analysis to help identify and mitigate potential risks. Escalate deviations to the CAPA process directly from the deviation document and have all information interlinked.

In case a deviation resolution leads to a document update, this process can then be controlled and managed via the change control management workflow. After the document update, automatic notifications for retraining activities can be automatically sent to the relevant people.

Connect to Other Systems to Manage the Entire Product Lifecycle

Centralize data from diverse sources to prevent data silos and losing important information.

Easily integrate SimplerQMS with existing systems such as CRM, ERP, LMS, MES, PLM, and others, using open API to manage the entire product lifecycle.

SimplerQMS Integration Illustration
Signing Deviation Document With an Electronic Signature

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Ensure Compliance With Life Science Requirements

Follow pre-configured workflows that support achieving compliance with Life Science requirements.

The system automatically records all actions in documents and provides complete time-stamped audit trails for full traceability.

Search for documents by using words mentioned in the title or content of the document, allowing for easy document retrieval.

Electronically sign documents using FDA 21 CFR Part 11 and EU Annex 11 compliant electronic signatures.

What Customers Achieve By Implementing SimplerQMS

Utilize Proven Technology

SimplerQMS is built on Microsoft & M-Files Technology which serves over 5,000 customers worldwide.


Pass Audit More Easily

Access needed documentation and present it to the auditor with a couple of clicks from anywhere in the world.


Gain High Level of Traceability

Gain cross-functional visibility and trace back to the root cause of each nonconformance.

“It’s very flexible, smooth, and easy to use. Documents no longer get lost and the whole history of all products is accessible for anyone at any time.”

Christian Schärfe Thomsen

Project Manager, Cortex

Discover How SimplerQMS Can Help You

Beyond Just Deviation Management

CAPA Management

Reduce the number of reoccurring issues by implementing effective preventive and corrective actions.

Change Control

Monitor all changes to documents and ensure compliance within your organization’s QMS.

Training Management

Track employee training activities and ensure that all your employees are trained on the latest procedures.

Document Management

Streamline all processes associated with the creation, approval, versioning, and storing of documents.

Audit Management

Schedule and manage audits in a single system, from internal to external audits, to supplier and regulatory audits.

Supplier Management

Qualify, select, and monitor supplier performance with a comprehensive supplier management module.

Frequently Asked Questions

What is Deviation Management System Software?

Deviation management software is a tool that helps track, manage, and generate reports on deviations. It allows companies to gain a better insight into deviations, identify trends or patterns, and effectively manage the entire process.

The system provides a more streamlined and automated approach to capturing the details surrounding a deviation, tracking its progress from initiation to closure, and monitoring the implementation of corrective and preventive actions, if necessary.

Companies can use deviation control and management software as a part of a complete eQMS software, such as SimplerQMS, to control the entire deviation management workflow and achieve compliance with regulatory requirements.

How Does the Deviation Management Workflow Look Like in SimplerQMS?

In SimplerQMS, the deviation management workflow starts with creating a deviation document from a document template. This process is known as issue recording. While drafting this document, you can assign employees to specific tasks, define due dates, specify other documents in scope, and more.

After the deviation document is drafted, you can route it for review or approval. Workflow participants will be automatically notified of required actions.

Documents can be edited in Microsoft Office Word (or other file formats) and are automatically stored in the cloud. When you Check-In the document, the changes are automatically saved and uploaded.

You can electronically sign deviation documents to record responsibilities and justifications for actions taken.

How Can I Escalate a Deviation to a CAPA?

You can directly escalate a deviation to a CAPA process from a deviation document.

When creating a deviation document, you are required to assign a specific person as the Issue Handler. This person is responsible for deciding the course of action regarding deviation resolution and can escalate deviation to the CAPA process if necessary.

Escalation is done with just a few clicks in the Action Menu inside the system. It also ensures that documents and data are interlinked.

Is Deviation Management Software FDA 21 CFR Part 11 and Annex 11 Compliant?

Yes, SimplerQMS software complies with FDA 21 CFR Part 11 and EU GMP Annex 11 regarding electronic records and electronic signatures.

How Much Time Does Deviation Management Software Take to Implement?

The SimplerQMS solution usually takes five to six weeks to be fully implemented.

The deviation management module is only part of our complete eQMS solution. Core modules, such as document control, change management, and training management, are implemented first.

Implementation times can vary depending on the number of documents created or uploaded within the software and available time resources.

How Much Does Implementing a Deviation Management Software Cost?

SimplerQMS Software prices depend on the number of licenses you acquire.

We provide a solution that includes all Life Science QMS modules, implementation, user training, and ongoing support. As a result, the total cost will depend on how many licenses you purchase.

If you want to learn more about our license types and all the features and services included, please visit our pricing page.

See What Our Customers Have to Say

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“Spending most of my day using SimplerQMS, I would say I am very pleased with the ease of use.”

Dorthe W.

QA/RA Manager, Cortex Technology

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“SimplerQMS gave us excellent pricing, customer support for understanding how to use their system and set up our QMS, and is easy to use.”

Subba S.

Chief Technology Officer, CollaMedix

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“Easy to work with. Intuitive. Rather easy to setup. Very good customer support. Good quality to price ratio.”

Jean Claude M.

Head of Hardware and Software Development, hemotune

See SimplerQMS in Action

To see SimplerQMS in action and learn how you can make the most of it, request a personalized demo presentation.

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