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AssurX Inc.
18525 Sutter Blvd., Ste. 150
Morgan Hill, CA 95037
Tel: 408/778-1376
Fax: 408/776-1267
Web: http://www.assurx.com
E-mail: info@assurx.com
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AssurX: Focused on Quality Management and Regulatory Compliance
AssurX's success is a result of building on a core belief that our employees and customers share a dedication to quality and innovation. As a privately held corporation that has been profitable every year since we opened our doors 14 years ago, we have fueled our phenomenal growth with a relentless commitment to providing practical, flexible, and secure quality management and regulatory compliance software that enhances operations and boosts your bottom line.
We possess exceptional domain expertise, a motivated and talented workforce, and a clear vision to create the most innovative products on the market today.
Simply put, we define the Best Practices that our competitors follow.
AssurX serves the FDA-regulated industry including manufacturers and suppliers of medical devices, medical electronics, packaging, pharmaceutical, biotech, and all related manufacturers and suppliers that cater to this industry.
PRODUCTS AND SERVICES:
AssurX, Inc., provides FDA-regulated organizations with enterprise-wide global solutions for their quality management and compliance systems needs.

Q & A: Galderma R & D A new streamlined approach for QA Audits and CAPA Processes
With a choice of OnDemand services or OnPremise (licensed) software delivery options, AssurX offers CATSWeb a flexible, comprehensive all-in-one solution that automates quality & regulatory compliance related processes so issues can be globally managed—from detection to corrective action to trend analysis. It helps collect, organize, analyze and share information to better manage and improve quality and compliance performance everywhere in your enterprise.
Turn-key processes such as corrective action management, complaint handling & regulatory reporting, issue tracking, audit management, customer support, and supplier quality are provided with full documentation, validation scripts, template forms, executive dashboards, and everything else needed for rapid deployment. Codeless configurability allows you to point-and-click your way to designing your own forms, workflows, rules, permissions, charts, dashboards, and an unlimited number of processes.

Bausch & Lomb: Implementing a Global 21 CFR Part 11 CAPA System (PDF)
Management Dashboards, KPIs and Metrics: CATSWeb comes with built-in (not added on) comprehensive, configurable reports, charts & dashboards enabling you to monitor key performance indicators and drill down to the underlying data - in real time, all the time without the need to install 3rd party reporting tools.
Reduce problems by tracking trends over time by site, department, product, activity or any other parameter. Manage resources by identifying and working on the largest issues first. Prevent recurring problems by determining root causes and implementing lasting effective solutions. Increase efficiencies by monitoring cycle times and reduce costs by process and site. Eliminate lost assignments by providing visibility to late tasks by area, department and individual.
Flexible and Robust Integration with Other Information Systems:
CATSWeb provides an open integration interface that enables you to add value by integrating with any of your existing information systems and databases.

Guidant: The Perils of Paper in an FDA-Regulated Environment
PROFESSIONAL SERVICES
AssurX maintains a staff of highly experienced life sciences domain consultants that are available to assist you in identifying operational areas and processes that can be improved, resulting in higher product quality, improved operational efficiencies, and cost savings.
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Categories this company is listed under in the North American Suppliers Directory:
- Manufacturing Equipment and Software: Software: Design software (172 companies)
- Manufacturing Equipment and Software: Software: Manufacturing software (248 companies)
- Manufacturing Equipment and Software: Software: Regulatory software (135 companies)
- R&D, Design, and Business Services: Software development/Validation (222 companies)



