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.
Achieve excellence in quality control of your medical devices with our software
Adherence to continuous improvement
Streamlined audit preparation
Reduced organizational risks
Bring this solution to your company
Why do customers choose SoftExpert
Kley Hertz
Comau
Hyundai
Buschle e Lepper
Dos Pinos
Learn how SoftExpert solutions can help you achieve standards certification and regulatory compliance
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.
Enterprise Quality - EQM
Modernize your quality management system (QMS) with an all-in-one solution. Reduce the effort to stay compliant, increase process agility, and gain transparency to drive continuous improvement with more control and efficiency.
Project and Portfolio - PPM
Transform your project and portfolio management with a complete, cloud-based, AI-powered solution aligned with PMBOK. Connect planning, execution, and monitoring through intelligent automation and real-time insights to ensure on-time delivery with quality and high performance.
Supplier Lifecycle - SLM
Manage the full supplier lifecycle with a cloud-based solution enhanced by Gen AI. SoftExpert SLM automates processes, qualifies partners, ensures compliance, and reduces risks with real-time insights. Boost performance visibility, efficiency, and trust with a secure, intelligent, and scalable platform.
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.
“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.”
Glossary
An award-winning platform recognized by customers
