Modernize your Quality and EHS system
Streamline processes, improve collaboration, and ultimately bring new drugs and medical devices to market quicker with the cutting-edge technologies like cloud EHS and EQMS systems.
Scale your Business and Capabilities
Meet your Integrated Management System needs across your Environment, Health & Safety, and Quality processes using the comprehensive Intelex platform.
Achieve Continuous Improvement through Collaboration
Remove disconnected operational tools and give your teams access to the information they need to drive continuous improvement, including metrics, KPIs, work instructions, and root causes to make effective decisions in real-time.
Comply with Regulatory and Customer Requirements
Bring safer and better-quality pharmaceuticals and medical devices to market while maintaining compliance with 21 CFR 11, GAMP5, ISO 13485:2016, and avoiding costly FDA 483s with Intelex's EHSQ Platform.
Intelex EHSQ Solutions
- Supports 21 CFR 11 compliance and electronic signatures
- Mobile-first strategy for your smartphones or tablets with offline capabilities
- Manage non-conformances, customer complaints, corrective actions and perform root-cause analysis
- Establish trends using historical data and identify problem areas to support continuous improvement initiatives
- Integrate with third-party systems like SAP, Oracle, ERP, HCM, Microsoft, CRM, Tableau and others using Intelex API and ODATA technologies
Intelex EHSQ solutionsValidation services for your QMS ensure your organization remains compliant with the FDA’s 21 CFR 820 regulation. It helps you avoid risk as your business evolves over time with a GAMP5 V-model methodology.
Intelex helps you configure, validate and host your Quality Management System software solution through our partnership with Glemser Technologies. Glemser’s in-depth know-how and 30 years of experience helps organizations improve quality, maintain compliance and take advantage of proven technologies.
Glemser validation services use robust, risk-based change controls and SDLC practices to ensure critical deliverables are ready for your project.
You’ll benefit from:
- Expert implementation based on best fit to drive performance
- Use of the Intelex cloud platform to realize the full potential of your investment and scale your business
- Minimal customization and lower total cost of ownership
- Effective best practices to meet compliance requirements
Glemser Validation ModelWe offer an effective validation methodology with best practices based on our experience that has been audited and accepted by our life science clients. Our approach to validation is pragmatic and risk-based with a focus on critical business and compliance requirements.
Glemser advocates a practical validation approach that provides an appropriate amount of documented evidence of compliance with an auditable process. We deliver high-quality validation at a reasonable cost through careful planning and execution.
Explore our software solutions for these essential areas of your business
Get to know our clients and the difference Intelex has made in their organizations.
Subaru Canada, based in Mississauga, utilizes the Intelex solution to track its employee training across the entire organization. In addition, the company can now bring all instructional tools and materials into one system for centralized control and management.
GBW Railcar, headquartered in Oregon, is a railcar repair shop with 40 locations scattered across 39 states in America. The company sought to discover issues of safety non-conformance within its operations, ultimately to prevent similar incidents through lessons learned.
EQT Corp., a natural gas company based in Pittsburgh, needed an employee health and safety system that was user friendly and able to provide in-depth analysis of data. Amber noted, “everyone at Intelex is concerned with our success as a company.”
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The Intelex Platform
The most powerful EHSQ platform on the market, it provides a robust and secure backbone to the Intelex system and the core management functionality upon which all Intelex solutions are built.More