Engineering Change Management Software
Streamline formal engineering change management processes with automated document routing, follow-ups, escalation, and approvals. Decrease review cycle times and time to market.
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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.
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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.
Automate 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.
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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.
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Solution That Goes Far Beyond Change Management
Document Control
Create documents, track revisions, control access, and manage your entire document control process from start to finish.
Design Control
Accelerate your device product development by linking systems, documentation, and records in a central location.
Non-Conformances
Streamline the process of identifying, evaluating, analyzing, and managing non-conformities.
CAPA Management
Quickly and easily identify, uncover, resolve, and report all the corrective and preventative actions (CAPAs).
Change Control
Document, review, and approve or reject changes in an organized manner to ensure compliance and structure within your QMS.
Risk Management
Effectively manage your risk files, easily identify potential risks, and take corrective action to mitigate them.
Frequently Asked Questions
What is Engineering Change Management Software?
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.
What are Popular Engineering Change Management Software Features?
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.
Is SimplerQMS Engineering Change Management Software Validated?
SimplerQMS provides a pre-validated solution, which complies with the requirements of the GxP, GAMP 5, FDA 21 CFR Part 11, and ISO 13485:2016.
We also 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.
Is SimplerQMS Engineering Change Control Software Part 11 Compliant?
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.
How Much Do Engineering Change Management Tools Cost?
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.
What Customers Achieve With 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.”
See What Our Customers Have to Say
“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
“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
“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.
