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Pharmaceutical Company Reduces Quality Risks and Streamlines Processes for Regulatory Requirements
Technology Category
- Functional Applications - Enterprise Resource Planning Systems (ERP)
Applicable Industries
- Pharmaceuticals
Applicable Functions
- Quality Assurance
Use Cases
- Regulatory Compliance Monitoring
Services
- Software Design & Engineering Services
- System Integration
The Challenge
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.
About The Customer
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.
The Solution
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.
Operational Impact
Quantitative Benefit
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