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

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

Pharmaceutical Company Reduces Quality Risks and Streamlines Processes for Regulatory Requirements

Sphera

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
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. Read More
About 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. Read More
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. Read More Log in to view content
Contents

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

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 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.

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.

Impact #1	Reduced time spent on risk assessments and ensured consistency of data
Impact #2	Decreased time spent on reporting from weeks to minutes
Impact #3	Saved millions of dollars by streamlining the process for complaint investigation

Impact #1

Reduced time spent on risk assessments and ensured consistency of data

Impact #2

Decreased time spent on reporting from weeks to minutes

Impact #3

Saved millions of dollars by streamlining the process for complaint investigation

Benefit #1	Reduced time spent on reporting from weeks to minutes
Benefit #2	Saved millions of dollars by streamlining the process for complaint investigation

Benefit #1

Reduced time spent on reporting from weeks to minutes

Benefit #2

Saved millions of dollars by streamlining the process for complaint investigation

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Overview

Pharmaceutical Company Reduces Quality Risks and Streamlines Processes for Regulatory Requirements

Operational Impact

Quantitative Benefit