Sphera > Case Studies > Pharmaceutical Company Reduces Quality Risks and Streamlines Processes for Regulatory Requirements

Pharmaceutical Company Reduces Quality Risks and Streamlines Processes for Regulatory Requirements

Customer Company Size

Large Corporate

Country

Worldwide

Product

Sphera’s Stature

Tech Stack

Risk Management Software

Implementation Scale

Enterprise-wide Deployment

Impact Metrics

Productivity Improvements
Cost Savings
Digital Expertise

Technology Category

Functional Applications - Enterprise Resource Planning Systems (ERP)

Applicable Industries

Pharmaceuticals

Applicable Functions

Quality Assurance

Use Cases

Regulatory Compliance Monitoring

Services

System Integration
Software Design & Engineering Services

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 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.

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

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

Quantitative Benefit