Engineering Change Management Software
Manage engineering changes in a controlled workflow to assess impact and maintain traceability.
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What’s in SimplerQMS Engineering Change Management Software?
SimplerQMS provides a cloud-based QMS software for life science organizations with a built-in engineering change management solution that allows your organization to create, share, review, and release engineering-related changes to speed up approvals.
Here are some of the core engineering change management features and benefits you get using SimplerQMS.
Streamline Engineering Change Management Process
Gain a competitive edge by cutting down your administrative overhead and costs related to disconnected and ineffective tools.
With SimplerQMS engineering change management software you can create and manage engineering changes with ease. Create documents using our best-practice engineering change request (ECR) forms, route documents for review or approval, follow up on approvals, escalate pending approvals, and more.
Easily create relationships between ECR, ECO, ECN, and documents related to engineering changes, so you always have complete visibility and control over your engineering changes.
Explore change control capabilitiesAutomate Design Review and Approval Processes
Design changes are a common occurrence in medical device engineering. When these changes happen, you need to have a structured process in place to review the changes, get approvals, and implement the changes.
SimplerQMS automatically notifies and sends email reminders to those who need to review or approve changes. Assignments can be escalated to the managers if someone doesn’t act in a timely manner.
You can also track the status of engineering changes, so you always know what’s happening and where things are in the process.
Connect Quality Processes In One Platform
When teams, data, and processes are siloed, engineering change management becomes complex and difficult. Disconnected tools only add to the problem by creating more inefficiencies. SimplerQMS is designed to help you overcome these challenges and streamline your medical device engineering change process.
The software integrates with various quality processes to ensure flawless change implementation, such as suppliers, training, non-conformances, CAPAs, and other processes. All documents can be linked to each other and are stored in a secure, centralized cloud-based storage for easy access and retrieval.
Enable End-To-End Traceability and Ensure Compliance
The ability to track engineering changes throughout the product life cycle is critical for quality and compliance.
SimplerQMS allows you to easily review changes in light of engineering drawings, requirements, artifacts, bills of material (BOMs), and documents linked to quality processes.
Furthermore, SimplerQMS is designed to ensure compliance with regulatory requirements and helps you comply with ISO 13485, FDA 21 CFR Part 820, 21 CFR Part 11, and GxP requirements. We provide features like electronic signatures, password authentication prior to approval, document versioning, time-stamped audit trails, and more. This makes it an ideal solution for businesses in highly regulated industries, like medical devices.
Solution That Goes Far Beyond Change Management
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What Customers Achieve With SimplerQMS
“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.”
Frequently Asked Questions
A digital engineering change management system helps medical device organizations streamline and automate their engineering change management processes. The software includes features like automated document routing, document versioning, audit trails, electronic signatures, reminders and notifications, follow-ups, escalation of activities, and more.
It helps ensure that all stakeholders are aware of the changes, that the changes are reviewed and approved in a timely manner, and that the final engineering documents are accurate and up-to-date.
Popular engineering change control software features include:
- Document linking: Link engineering changes to other quality processes like suppliers, training, non-conformances, CAPAs, and more.
- Automated review and approval processes: Automatically notify and send email reminders to those who need to review or approve changes.
- Change status tracking: Track the status of engineering changes, so you always know what’s happening and where things are in the process.
- Cloud-based storage: Store documents in a secure, centralized cloud-based storage for easy access and retrieval.
- Microsoft Office integration: Open and edit documents directly in Microsoft Word, Excel, or PowerPoint.
- Out-of-the-box regulatory compliance: SimplerQMS is designed to help you comply with requirements applicable to medical device manufacturers, such as ISO 13485, FDA 21 CFR Part 820, 21 CFR Part 11, and GxP requirements.
SimplerQMS provides a fully validated solution, which complies with the requirements of the GxP, GAMP 5, FDA 21 CFR Part 11, and ISO 13485:2016.
We ensure continuous re-validation of the software and provide extensive validation evidence for use during audits and inspections. Including a validation plan, procedures, reports, as well as, IQ, OQ, and PQ documentation.
SimplerQMS software solution is a 21 CFR Part 11 compliant software system, designed to help Life Science organizations comply with the Electronic Signature and Digital Record practices set forth by the US FDA’s 21 CFR Part 11.
The SimplerQMS engineering change management solution is part of a QMS software subscription that includes all core QMS 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 total price depends on the number of users and the type of licenses. Therefore, we recommend you talk to our experts and request a pricing quote for the needs of your organization.
