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实例探究 > An eQMS that builds client trust

An eQMS that builds client trust

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
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.
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.
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
  • The eClinical Solutions team gave themselves a controlled, compliant and continuously improving eQMS to show excellence to clients.
  • eClinical Solutions face over 50 customer audits a year, as well as ad hoc quality information requests from customers and prospects. Qualio delivered a clear step-up from their old systems, which worked with clunky shared logins and SSO functionality.
  • The team can now quickly share external access to a single, controlled source of quality truth, proving their quality credentials, satisfying regulators and winning new business.
数量效益
  • 50 Remote customer audits a year handled in Qualio
  • 3x FTE Spend mitigated by eQMS investment
  • 25% Company growth since implementation

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