Gilero: Managing Multiple FDA Regulated Sites with Intellect
公司规模
Mid-size Company
地区
- America
国家
- United States
产品
- Intellect’s eQMS Suite
- Intellect’s Document Control App
- Employee Training App
- Calibration and Maintenance App
技术栈
- No-code platform
实施规模
- Enterprise-wide Deployment
影响指标
- Productivity Improvements
- Digital Expertise
技术
- 应用基础设施与中间件 - API 集成与管理
适用行业
- 医疗保健和医院
- 生命科学
适用功能
- 质量保证
- 产品研发
服务
- 软件设计与工程服务
- 系统集成
关于客户
Gilero is a North Carolina-based company that was founded in 2002 as an engineering design firm with a focus on single-use medical devices. Over the past five years, the company has expanded its offerings to include everything from consumable medical devices to full electromechanical drug delivery systems, and has added manufacturing services. It now has locations across the globe. Gilero handles the design, development, and contract manufacturing of medical and drug delivery devices from concept to commercialization. Most of Gilero’s customers are medical and pharmaceutical companies. It also works with VC-funded startups, entrepreneurs, clinical professionals, and others looking to bring an idea to life and deliver it to market. Because it operates in the medical industry, compliance with the FDA and other international regulatory agencies is mandatory to Gilero’s business.
挑战
Gilero, a company that handles the design, development, and contract manufacturing of medical and drug delivery devices, was facing challenges with its original Quality System. The system, built in 2011, was paper-based, manual, and became complex over time. As the company expanded to new locations, the complexity of the system grew, as did the amount of time needed to manage it. The team at Gilero realized that it would need a quality management software in order to improve efficiency, streamline processes, and minimize the errors endemic in a manual system. However, many of the software platforms available required users to have coding and software engineering experience, which would mean hiring additional personnel.
解决方案
Gilero chose Intellect’s eQMS Suite and no-code platform for its accessibility and ease of use. The software allowed for real-time, hands-on training, and could be easily operated by everyone on the team, regardless of their computer software programming experience. Gilero initially focused on Intellect’s Document Control App and the Employee Training App, with plans to roll out Intellect in other areas such as Calibration and Maintenance, Non-conformances, and CAPAs. The software was easily configurable to conform to Gilero’s own document numbering strategy and additional requirements of Gilero’s training program. Gilero is also implementing the Calibration and Maintenance App to replace its existing calibration software and make its maintenance program fully electronic, allowing for seamless collaboration between quality engineers in North Carolina and design engineers in California.
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