Sphera > 实例探究 > Pharmaceutical Company Reduces Quality Risks and Streamlines Processes for Regulatory Requirements

Pharmaceutical Company Reduces Quality Risks and Streamlines Processes for Regulatory Requirements

公司规模

1,000+

国家

Worldwide

产品

Sphera’s Stature

技术栈

Risk Management Software

实施规模

Enterprise-wide Deployment

影响指标

Cost Savings
Digital Expertise
Productivity Improvements

技术

功能应用 - 企业资源规划系统 (ERP)

适用行业

药品

适用功能

质量保证

用例

监管合规监控

服务

软件设计与工程服务
系统集成

关于客户

The customer is one of the world’s largest pharmaceutical companies, with clinical research conducted in more than 50 countries and manufacturing plants in over 12 countries. The company is focused on continuous process improvement for their quality risk management. In 2009, the company identified an opportunity to improve current processes with the goal of reducing product defects across its worldwide operations. The company adopted Sphera’s Stature® as a consistent means of conducting Risk Assessments. The company recognized that they had an opportunity to grow into optimizing their solution – not to become more efficient only, but gain further visibility than they had in the past.

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挑战

The pharmaceutical company, with clinical research conducted in more than 50 countries and manufacturing plants in over 12 countries, identified an opportunity to improve current processes with the goal of reducing product defects across its worldwide operations. The company lacked a centralized tool to capture requirements or to conduct risk assessments for hundreds of their products within many product families. As a result, in order to meet regulatory guidelines, the company maintained multiple spreadsheets as well as Process Flow Documents which were over 100-pages long for each product family! This created a very complex and cumbersome process. In addition, since the information was contained in multiple sources, there were no linkages between the requirements and controls, and the content was difficult to search and query. It also meant reliance on a few experts who could assess the relationships between all these elements.

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解决方案

The company engaged with Sphera to implement a centralized risk management solution. The company adopted Sphera’s Stature® as a consistent means of conducting Risk Assessments. The introduction of Stature as a centralized risk management tool has enabled the company to create an end-to-end process which includes multiple interacting templates that connect the requirements to the PHAs, DFMEAs, PFMEAs, AFMEAS and related control strategies. Now the process is optimized, so for every requirement they can readily identify all the related controls and this in turn has brought many benefits, including improved visibility and the ability to easily answer questions such as ‘What are the controls around a Specific requirement?’ or ‘Which requirements are impacted at each manufacturing step?’. It also allows improved traceability since the relationships are built between elements in the system.

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运营影响

Reduced time spent on risk assessments and ensured consistency of data
Decreased time spent on reporting from weeks to minutes
Saved millions of dollars by streamlining the process for complaint investigation
Improved visibility and the ability to easily answer questions such as ‘What are the controls around a Specific requirement?’ or ‘Which requirements are impacted at each manufacturing step?’
Improved traceability since the relationships are built between elements in the system

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数量效益