FDA 21 CFR Part 820

Achieve regulatory compliance and medical device excellence, ensuring quality and safety with robust management of FDA 21 CFR Part 820 requirements.

Solve your challenges
Promptly resolving quality issues identified in medical devices.
Monitoring and ensuring that suppliers also comply with the requirements of FDA 21 CFR Part 820.
Maintaining up-to-date accuracy of all documentation necessary to demonstrate regulatory compliance.

Achieve excellence in quality control of your medical devices with our software

Adherence to continuous improvement

Ensure process and device quality with a proactive approach to identifying and correcting deviations encountered and required improvements.
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Streamlined audit preparation

Simplify the management of all audit stages, from planning to execution, ensuring time and resource savings.
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Reduced organizational risks

Identify and mitigate potential risks to medical device safety, protecting both consumers and brand reputation.
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Why do customers choose SoftExpert

Kley Hertz

Success Case
Kley Hertz enhances processes, ensures information security, and increases productivity by 60% with SoftExpert
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Success Case
Comau increases operational efficiency and reduces risk of failure by 60% with SoftExpert
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Success Case
Hyundai reduced rework by 57% by automating its innovation program
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Success Case
Buschle & Lepper boosts performance with an 81% increase in preventive maintenance and expands revenue with SoftExpert
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Success Case
Dos Pinos centralizes 186 services with SoftExpert Suite and saves over 30% by implementing a Shared Services Center (SSC)
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Learn how SoftExpert solutions can help you achieve standards certification and regulatory compliance

Enterprise Content - ECM
Enterprise Quality - EQM

Enterprise Content - ECM

SoftExpert ECM is a comprehensive enterprise content management software solution that centralizes all organizational content. It allows you to create, capture, manage, store, preserve and share documents and records, reducing paperwork and related deviations. The ECM solution ensures security, integrity, reliability, and compliance with international standards such as ISO 9001 and FDA 21 CFR Part 11.

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Enterprise Quality - EQM

Modernize your quality management system with quality management software, reduce the work required to maintain compliance, improve agility and transparency, and promote continuous improvement across your organization while increasing customer satisfaction.

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Compliance with global privacy and security standards

Advanced data protection

SoftExpert ensures the protection of your company's data and compliance with the requirements of the latest standards.

Integrate with your ERP, CRM, Office365, and much more

Connect SoftExpert Suite to other business tools already used in your organization.

Worldwide Office Locations

Supporting and implementing your growth and expasion everywhere! We are present locally, ready to ensure that SoftExpert solutions are working without limits.

Customize the solution to your needs

Add new modules to your product, customize your experience and get all the solutions you need for your company.

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Get to know our Enterprise solution

“Now, with the company’s document management, business process automation and dynamic action assignments up and running, Yorozu Automotive Alabama is able to easily retrieve and analyze incident resolution records to support continuous improvement efforts. This takes efficiency to a new level.”

Kenny Reed - Director of Quality Assurance
Yorozu

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