Design Control Software

Accelerate your medical device product development by linking systems, documentation, and records in a central location.

Use forms to build and connect your design control documentation

Easily create design control records based on forms for documenting your product development. We provide readily available forms, or we can help you migrate your forms and procedures into the system.

With SimplerQMS, you can link design control records to change requests, products, components, suppliers, customers, equipment, or other documents.

Recommended Reading: Design Controls for Medical Devices

Maintain an audit-ready design control documentation

SimplerQMS makes you better prepared for any audit. All records and approvals, for a specific product, with versioning, audit trail, and electronic signatures, can easily be found in one location.

Our Technical File / Design History File (DHF) Dashboards give you an overview and quick access to necessary documentation. Furthermore, our built-in Google-like search functionality can also help you quickly find necessary documentation.

Design control documents can be related to multiple archives, for example, DHF, DMR, TF, 510k submission, CE Marking, etc. This means that one file can be placed in multiple archives with no need to have duplicates of the same files.

See Our Design Control

Possibilites in Action

This video is a part of a DEMO presentation that explains how SimplerQMS handles design control documentation. Take a look at how the system handles linking to archives, metadata, building of design control structures and external document workflows.

Generate and export DHF, DMR, and TF when needed

With SimplerQMS you won’t have to waste time searching for the required documentation when compiling your DHF, DMR, and TF. With our Document Collection Tool, you can easily make a “snapshot” of the current documentation for each product. Afterward, documentation can easily be exported or shared externally.

Recommended Reading: Design History File (DHF): What It Is & What Does It Include?

Overview design documentation by product or component

With SimplerQMS, you can link design and development documentation to specific products or components and maintain a DHF, DMR, TF for each product.

Our Design Control Software is designed to securely store all the needed documentation for each product that you would need for a 510k submission or CE Marking.

Save time by using a single repository

With SimplerQMS you can use a single repository for any design documentation such as drawings, reports, notes, images, and videos. You can then reference these files to procedures, products, components, suppliers, equipment, and processes. This way you can easily develop fully traceable technical documentation.

Ensure compliance across everyone in your team

Inaccurate, incomplete documents and unapproved documents changes can easily cause delays in product development. With SimplerQMS you can avoid these issues by creating and maintaining Design Control SOPs and forms that enforce learning activities and capture training records for the employees that need to follow them.

Perform and document design review activities digitally

SimplerQMS allows you to sign Design control documents with built-in 21 CFR Part 11 Compliant electronic signatures and automatic workflows.

This means that your team can stop wasting time manually circulating documents and chasing wet signatures.

Jira integration

Documentation from Jira can easily flow into SimplerQMS.

This allows you to connect your Technical Documentation to the quality documentation in your eQMS.

Looking for more modules?

Regardless of the stage of your Life Science organization, our integrated software modules cover all your needs.

Training Management Module Icon

Training Management

Save time with automated training activities, learning overview, reminders, and generation of training certificates.

CAPA Management Icon

CAPA Management

Identify, uncover, resolve, and report all the preventative actions and corrective actions (CAPAs) seamlessly.

Complaint Management Module Icon

Complaint Management

Reduce the associated risks and resolve issues quickly by optimizing complaint management processes.

Change Management Module Icon

Change Management

Recognize and manage all changes accordingly to ensure compliance and structure within your organization’s QMS.

Deviation Management Icon

Issue Management

Simplify your issue management workflows by automating tedious tasks.

Document Management Module Icon

Document Control

Automate and standardize your document control activities with ease.

Equipment Calibration Icon

Equipment Calibration

Manage your equipment calibration schedule and automatically assigns tasks before due dates.

Electronic Signature Module Icon

Electronic Signatures

Sign and send the necessary documents for authoring, review, approval, from anywhere in the world, at any time.

Product Lifecycle Management Icon

Product Lifecycle

Plan and organize all your product management activities and integrate them with other processes.

Audit Management Icon

Audit Management

Automate your audit-related activities and ensure better audit preparedness.

Risk Management Icon

Risk Management

Consolidate risk and handle your risk management file in a well-organized and structured manner.

Supplier Management Module Icon

Supplier Management

Simplify supplier-related activities and handle your supplier documentation following the standards.

Form Management Icon

Form Management

Standardize your documentation processes and boost employee productivity with effective document forms.

Deviation Management Icon

Deviation Management

Streamline the investigation, documentation, and resolution of all your deviations.

Electronic Batch Records Icon

Electronic Batch Records

Digitize and automate your batch record processes to ensure regulatory compliance.

Nonconformance Management Icon

Nonconformance Management

Identify, evaluate, analyze and manage nonconformances more efficiently.

Trusted by companies around the world

Ready to learn more?

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

SimplerQMS Demo Interface