An eQMS that builds client trust
公司规模
Large Corporate
地区
- America
- Asia
国家
- United States
- India
产品
- Qualio
技术栈
- Cloud-based platform
- Electronic system workflows
实施规模
- Enterprise-wide Deployment
影响指标
- Productivity Improvements
- Customer Satisfaction
- Digital Expertise
技术
- 功能应用 - 企业资源规划系统 (ERP)
适用行业
- 生命科学
适用功能
- 质量保证
服务
- 系统集成
- 培训
关于客户
eClinical Solutions provides a cloud-based clinical data software platform which makes truly digital clinical trials possible. eClinical Solutions empowers its clients in the clinical trial space with sharper insights and complete visibility of their trial journeys, from clinical analytics and biostatistics to data control. The company has grown significantly, including expanding its operations in India, and has embraced remote work. They handle over 50 remote customer audits a year and have seen a 25% company growth since implementing their new eQMS.
挑战
eClinical Solutions could get by with a paper-based quality management system while they were still a small, single-site operation. Things began to change as the company expanded its growth (including its Indian operations), widened its hiring radius and embraced more remote work, and as COVID-19 arrived. The company moved to a trial master file-based content management platform but found it lacked the extra QMS functionality they needed, such as full CAPA and training management. It was clear eClinical Solutions needed a holistic, purpose-built eQMS. VP of Quality & Compliance Evan Grunbaum and his team started to search for a tool which would eliminate their manual ceiling and free up the company to scale.
解决方案
The team were immediately drawn to the intuitiveness and ease of use offered by Qualio. Evan could access the company QMS at a glance and drill into a web of connected quality information in seconds. Internal Training Manager Aminah Brelvi knew the system would be easy for new hires to grasp, with functionality like Qualio's Training Overview providing snapshot visibility of company compliance. And QA Manager Angel Baez Vega could use electronic system workflows to manage quality events to completion and continuously improve the company's operation. With its balance of functionality, price and ease of use, Qualio was selected as eClinical Solutions's new eQMS, and the team went live in 2021.
运营影响
数量效益
Case Study missing?
Start adding your own!
Register with your work email and create a new case study profile for your business.
相关案例.
Case Study
Corporate Identity Solution Adds Convenience to Beckman Coulter
Beckman Coulter wanted to implement a single factor solution for physical and remote logical access to corporate network. Bechman Coulter's users were carrying smart card badges for doors, but also needed a one-time password token to access to our corporate network when they were not in the office. They wanted to simplify the process.
Case Study
Embracing Business Success in Real Time
· Increase control over growing Big Data to improve business decisions · Manage data for 28,000 biotechnology stockkeeping units in the fields of microbiology, molecular biology, animal cell cultures, plant tissue cultures, and lab ware for laboratory chemicals · Accelerate report generation and analysis with real-time data
Case Study
Flow Robotics: Scaling Up Production and Accelerating Product Development with IoT
Flow Robotics, a Danish manufacturer, developed flowbot™ ONE pipetting robots to alleviate the strain on bioanalysts in life-science laboratories and hospitals across Europe. These robots were designed to automate part of the testing process, speeding up the time it takes to produce results and reducing pressure on staff. However, the company faced challenges in scaling up production and accelerating product development. High workloads and physically challenging conditions have long been an issue for laboratory professionals. Flow Robotics estimates that around half of medical lab technicians carry out the same arm movements for at least a quarter of their working day. The American Society for Clinical Pathology reported that 85% of laboratory professionals feel burnt out; 36% struggle with inadequate staffing; and 32% face a heavy workload and pressure to complete all testing on time.
Case Study
Revolutionizing Aerospace Industry with 3D Printing: A 63% Lighter Titanium Part
GE Aviation, a renowned name in the aerospace industry, recognized the potential of 3D printing technology in transforming the sector. The primary challenge was to reduce the weight of the aerospace parts, which would directly impact the fuel costs. A lighter airplane would mean lower fuel consumption, leading to cost savings and a smaller carbon footprint. However, achieving this weight reduction without compromising the strength and functionality of the parts was a significant challenge. Traditional manufacturing methods were not able to provide the desired weight reduction while maintaining the required stiffness and strength of the parts. The challenge was to find a solution that could create strong, light, and functional aerospace parts.
Case Study
Material Intelligence at Ethicon: Sustaining Medical Device Manufacturability and Improving Patient Care
Ethicon, a world-class medical devices company, faced several challenges in its operations. The rapid selection of manufacturing materials compliant in global markets was critical to assure patients, practitioners, and purchasing organizations of the biocompatibility of their medical devices. Ensuring supply chain continuity and minimizing risks of obsolescence for medical devices due to regulatory changes were also crucial in meeting Ethicon’s ongoing commitment to maintaining patient care. Furthermore, the engineers at Ethicon were developing the next generation of medical devices and needed to access historical material data to accelerate new product development. The process of centralizing and digitalizing its materials information was a significant challenge that Ethicon needed to overcome.
Case Study
IWT's Transformation: Customizing with Efficiency in IoT
IWT, a company specializing in the design, manufacture, and installation of washing systems for the life sciences and pharmaceutical industries, faced a significant challenge in managing its wide product portfolio. The company manufactures 45 different models, 60% of which are customized to some degree. This high level of customization, combined with limited production quantities, necessitated a controlled process for managing the release of engineering changes. The goal was to achieve efficiency, reduce process time, and better coordinate production throughout the organization. The need for strict compliance in heavily regulated industries further complicated the situation. IWT's existing PLM journey with Dassault Systèmes’ SOLIDWORKS for 3D CAD and Enovia for managing CAD data and Bills of Materials (BOMs) was proving inadequate. The system had limited part classification, no workflow, and no tool to ensure data consistency. The management of non-CAD documents was also a challenge, with information often difficult to find and access.
