Intelex and Glemser Technologies partner together to help you configure, validate and host your Quality Management System (QMS) software solution. Glemser’s 30 years of experience and expertise helps organizations improve Quality, maintain compliance with 21 CFR Part 11, ISO13485:2016 and take advantage of proven technologies to transform your organization.
Streamline processes, improve collaboration and ultimately bring new drugs and medical devices to market more quickly with cutting-edge technologies like cloud EHS and EQMS systems.
An Integrated EHSQ Solution
Help meet the needs of your Integrated Management System across your Environment, Health & Safety and Quality processes with Intelex’s fully integrated EHSQ platform.
Continuous Improvement through Collaboration
Remove disconnected operational tools and give your teams access to the information they need, including metrics, KPIs, work instructions and root causes, to drive continuous improvement and make effective decisions in real-time.
Comply with Regulatory Requirements
Enhance the safety and quality of the pharmaceutical products and medical devices you bring to market while maintaining compliance with 21 CFR Part 11, GAMP5 and ISO 13485:2016, and avoiding costly FDA 483s.
Intelex EQMS Solutions for Life Sciences
- Manage non-conformances, customer complaints, corrective actions and perform root-cause analysis
- Manage quality documents, quality training, incidents, audits, supplier audits, supplier relationships, changes, risks, products and shipping, receiving and inspections
- Establish trends using historical data and identify problem areas to support continuous improvement initiatives
- Mobile-first strategy for your smartphones or tablets with offline capabilities
- Supports 21 CFR Part 11 compliance, electronic signatures and ISO 13485:2016
- Integrate with third-party systems like SAP, Oracle, ERP, HCM, Microsoft, CRM, Tableau and others using Intelex API and ODATA technologies
Glemser Configuration and Validation ServicesGlemser leads the configuration and validation of Intelex QMS applications through an effective methodology based on best practices that has been audited and accepted by North American and European life science clients. This approach to validation is pragmatic and risk-based with a focus on critical business and compliance requirements issued by the FDA.
Glemser advocates a practical validation approach that provides an appropriate amount of documented evidence of compliance with an auditable process. Glemser delivers high-quality validation at a reasonable cost through careful planning and execution. The methodology is based on the following validation model and delivers the following documentation artifacts.
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.
Following a global expansion, England-based produce supplier IPL had to ensure employees in all locations had access to the same data. Intelex ensures they can access it from one source.
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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