Ditching admin tasks with the help of a supportive eQMS vendor
公司规模
11-200
地区
- America
国家
- United States
产品
- Neubie
- Qualio
- Qualio+
技术栈
- eQMS
- DocuSign
- Dropbox
实施规模
- Enterprise-wide Deployment
影响指标
- Customer Satisfaction
- Employee Satisfaction
- Productivity Improvements
技术
- 功能应用 - 计算机化维护管理系统 (CMMS)
- 功能应用 - 企业资产管理系统 (EAM)
- 功能应用 - 企业资源规划系统 (ERP)
适用行业
- 医疗保健和医院
适用功能
- 质量保证
用例
- 监管合规监控
服务
- 系统集成
- 培训
关于客户
NeuFit is an Austin-based manufacturer of Neubie, a neuromuscular electrical stimulation medical device. Neubie helps patients recover from neuromuscular damage and can treat conditions from plantar fasciitis to strokes and spinal cord injuries. NeuFit's team is small, with a Director of Operations & Quality Management, Ami Anderson, who is responsible for managing quality activities. The company faced significant challenges with their manual paper- and Dropbox-based system, which was cumbersome and time-consuming. This manual system led to inefficiencies and difficulties in managing quality and operations, especially during audits.
挑战
NeuFit relied on a manual paper- and Dropbox-based system to manage their quality activities. Documents required a cumbersome approach of downloading, editing, and passing to DocuSign for every edit. Key document updates were easily forgotten, and searching for information in multiple logs and filing cabinets became overwhelming. Director of Operations & Quality Management Ami Anderson spent 'every day, all day, and a lot of overtime thrown in' just completing quality admin tasks. Since her team of 2 were paid hourly and Ami was salaried, she would be first in line for after-hours work if things didn't get done. This excessive quality timesink meant the other half of her role – operations – didn’t get the same attention, causing issues in areas like supplier management. The issues with NeuFit’s manual system came to light when an FDA auditor arrived with a thumb drive, expecting to be able to load electronic quality documents and take them away with her. Her bag wasn’t large enough to hold the paper documents prepared by the NeuFit team.
解决方案
Ami homed in on three potential eQMS vendors for closer inspection. One option still required lots of manual change control, including downloading system documents for revision then re-uploading. The second option put Ami off with overly pushy sales tactics, which included putting down other eQMS vendors and overpromising functionality. During discussions with Qualio, Ami felt comfortable to discuss and explore her operational requirements without pressure. On top of that, the system itself met all of NeuFit’s needs. After NeuFit’s CEO Garrett Salpeter was impressed by Qualio too, sign-off was given to become Qualio customers. NeuFit took on additional Qualio+ support to accelerate their quality and compliance journey, and Ami was pleased by the entire onboarding and training experience.
运营影响
数量效益
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