Enterprise Quality Management System Software

Streamline quality processes and ensure regulatory compliance across the entire enterprise.

SimplerQMS Document Control Interface - Procedure List


What’s in SimplerQMS Enterprise Quality Management Software?

SimplerQMS provides a cloud-based enterprise quality management software that helps enterprises streamline quality processes, work more efficiently, and ensure compliance with regulatory requirements. Here are some of the core features and benefits you get using SimplerQMS.

Automated Document Workflow Description in SimplerQMS

Click to Enlarge Image

Automate Document-Related Processes

A well-designed document management system is essential for an enterprise QMS. By automating the process of creating, approving, distributing, and archiving documents you can ensure that they are effective and efficient.

With SimplerQMS you can create and manage documents with ease. Store all your documents in a central repository and keep track of their step-by-step development thanks to automated workflows. The workflows ensure that the authors, reviewers, and approvers you assign to each document get instantly notified about their tasks, streamlining the work of your employees.

SimplerQMS also offers FDA 21 CFR Part 11 compliance electronic signatures which make it easy to get sign-offs from anywhere in the world.

Easily Manage and Track Employee Training

A well-run enterprise QMS ensures that all employees receive the necessary training and that this training is delivered effectively and efficiently.

Using SimplerQMS, you can create, assign, and track employee training tasks with ease. You can create groups that will get the same learning assignments and make sure that people only have to read the documents that are relevant to them. Learning assignments are sent immediately after you release or update the target document and you can ensure you stay compliant by continuously tracking the training your employees carry out.

The software also sends out automated notifications and reminders to ensure all employees receive the necessary training on time.

Employee Training Assignment Statuses in SimplerQMS

Click to Enlarge Image

Change Request List in SimplerQMS

Click to Enlarge Image

Track and Manage Changes Across the Organization

It’s crucial to link changes with the processes they impact, allowing users and data to be connected in one central system.

With SimplerQMS you can easily create, track, approve and manage changes across your entire company with ease. The system gives you opportunities for customizing your Change Request process but limits you in places that would jeopardize compliance.

Send change request documents through an automated workflow and ensure that all relevant stakeholders are notified of any changes, allowing them to review and approve them before they are implemented. You’ll rest easy knowing that all your changes are registered and compliant.

Reduce Time Spent on Audits

With the right software solution in place, you’ll be well-prepared for any quality audit, at all times.

SimplerQMS offers a powerful audit management module that helps you prepare for different kinds of audits, schedule them ahead of time, and track their progress. The software acts as an audit checklist that allows you to easily manage the needs for every audit you have to go through.

From document control, with time-stamped audit trails and the FDA 21 CFR Part 11 compliant electronic signatures, with automated assigning of tasks and notifications, SimplerQMS helps you streamline quality and compliance. Each version of a document’s life is well documented and will allow you to walk any auditor through the history of your organization’s development.

Nonconformance Audit Trail in SimplerQMS

Click to Enlarge Image

Connected Documents and Products in SimplerQMS

Click to Enlarge Image

Connect Processes Across the Entire Product Lifecycle

SimplerQMS provides a closed-loop quality management solution by connecting processes across the entire product life cycle. This ensures that quality is considered at every stage of the product life cycle, from design to delivery and beyond.

Ensure that your documents are filed in the right archives, link them to current and future R&D projects and get them organized for regulatory submissions. Manage your products, parts, and components down to the batch or serial number in one platform. Linking these to both pre-and post-market activities such as equipment, risk management, manufacturing instructions or CAPAs, customer complaints, and non-conformances is as easy as the press of a button.

Streamline Supplier Related Documentation Processes

Maintaining supplier documentation manually can be error-prone and time-consuming.

The SimplerQMS provides a streamlined process for selecting, qualifying, and monitoring your suppliers. Choose between standard or quality-critical suppliers and file documentation as proof quickly and efficiently.

Track and manage supplier performance data and documentation in one central location, and ensure that all your quality data is accurate and up-to-date. Furthermore, periodic monitoring secures that you manage supplier quality data and documentation continuously.

Supplier Management Actions List in SimplerQMS

Click to Enlarge Image

All-in-One QMS Software for Life Sciences

Training Management

Save time by automated training assignments, reminders, generation of training certificates, and more.

Document Control

Manage all of your documents in one central repository, track changes, maintain version control, and disseminate information to stakeholders with ease.

CAPA Management

Identify, uncover, resolve, and report all CAPAs and ensure issues are mitigated and prevented from recurring in the future.

Complaint Management

Automate various customer complaint management tasks, including the intake of customer complaints, generation of reports, and more.

Change Management

Streamline the process of identifying, assessing, and implementing changes to your enterprise’s quality management systems (QMS).

Supplier Management

Simplify supplier-related activities and ensure that all supplier documentation is handled in a consistent and compliant manner.

Frequently Asked Questions

What is an Enterprise Quality Management System?

An enterprise quality management system (EQMS) helps document and manage business processes for product development, manufacturing, quality management, and regulatory compliance.

It offers a holistic, top-down view of quality management that helps streamline the management of complaints, suppliers, quality audits, non-conformances, CAPAs, and other quality processes.

As the cost and complexity of goods continue to rise, many organizations are finding that they need a more advanced system for managing quality.

Digital Enterprise Quality Management Systems provide these capabilities with features like electronic signatures, automated workflows, centralized document repository, and others. As a result, it is possible to drastically improve efficiency within a business’s operations – all while saving time!

Plus, such software solution, nowadays, typically has a cloud-based IT infrastructure that facilitates cross-functional communication from anywhere in the world.

What Makes Enterprise Quality Management System Software Popular?

Popular SimplerQMS enterprise quality management software features include the following features (and more!):

  • Microsoft Office integration: Work on your documents in Microsoft Word, Excel, and PowerPoint and store them with one click in SimplerQMS Cloud. No need to export and then upload documents to the system.
  • FDA 21 CFR Part 11 compliance: The software includes features that help you to comply with FDA 21 CFR Part 11 requirements such as electronic signatures, time-stamped audit trails, and others.
  • Automated workflows: Send documents through an automated workflow for authoring, review, and approval processes. Plus, automate notifications, reminders, and escalation of overdue assignments.
  • Centralized cloud-based repository: Store all your quality documents in one centralized, cloud-based repository. Access them anytime, from anywhere, with an Internet connection.
  • Integration with other quality processes: Connect data with other quality processes such as quality audits, customer complaints, non-conformances, suppliers, and CAPAs. Or integrate SimpleQMS with other existing applications like an ERP, CRM, or PLM software solution via an API (Application Programming Interface).

Is SimplerQMS Enterprise Quality Management Software Validated?

SimplerQMS provides a fully validated software solution, which complies with the requirements of the GxP Guidelines, FDA 21 CFR Part 11, and ISO 13485:2016.

Furthermore, we ensure continuous re-validation of the software and provide extensive validation evidence for use during audits and inspections. We provide validation plan, procedure, report, as well as, IQ, OQ, and PQ documentation.

How Much Does Enterprise Quality Management Software Cost?

SimplerQMS enterprise QMS software solution is part of an all-inclusive subscription, which includes all system modules, implementation, training, ongoing support, validation, hosting, and more.

This means that everything is included in the price you pay and there are no other costs associated with subscribing to SimplerQMS.

The price of the solution differs depending on how many people will use it.

Therefore, we recommend you book a tailored demo and talk to our experts to request a pricing quote for the needs of your organization.

How Much Time Does It Take to Implement a Digital Enterprise QMS?

Depending on whether you already have a Quality Management System (QMS), and the number of documents, implementation time may be shorter or longer.

We take pride in helping our clients launch and start using SimplerQMS quickly. Our track record shows that the average implementation time is 5-6 weeks.

Is Your Enterprise QMS Software a Good Fit For My Organization?

Whether you’re a ten-person business or a large-scale enterprise, the SimplerQMS quality management platform scales with your needs.

You can request a demo to learn more about the SimplerQMS solution and how it would fit your organization.

What Customers Achieve With SimplerQMS

“The chance of a human error in the process of filling out documents has been reduced. There are several different human errors that have been eliminated and we feel like the system helps us to catch possible human errors more easily.”

christian photo

Christian Schärfe Thomsen
Project Manager, Cortex

Ready to learn more?

To learn how your enterprise can make the most of SimplerQMS, request a free demo presentation.

SimplerQMS Demo Interface