Sphera Case Studies Reduce Quality Risk and Streamline Regulatory Processes

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	Reduce Quality Risk and Streamline Regulatory Processes Sphera

Reduce Quality Risk and Streamline Regulatory Processes

Sphera

Technology Category	Application Infrastructure & Middleware - Data Exchange & Integration
Applicable Industries	Pharmaceuticals
Applicable Functions	Quality Assurance
Use Cases	Regulatory Compliance Monitoring Root Cause Analysis & Diagnosis
Services	System Integration
Challenge	The global pharmaceutical company was facing challenges in managing quality risk and reducing product defects. The transition from conventional to biopharma drug production had made compliance more complex and traceability crucial. The company was using spreadsheets and extensive process flow documents to conduct risk assessments for hundreds of products. This process was complex, cumbersome, and difficult to query. The elements of the process were not clearly linked, making the investigation of complaints burdensome and expensive. The company was dealing with disparate risk assessment processes across more than 62 countries, using time-intensive, manual reporting tools, and had an ineffective complaints analysis process. Read More
About Customer	The customer is one of the world's largest pharmaceutical companies, with patient safety and regulatory compliance as their top priorities. The company has a global presence, operating in over 62 countries. It generates a revenue of $22.3 billion and employs over 33,000 people. As the company transitions from conventional to biopharma drug production, it faces increasing complexity in compliance and traceability. The company was using spreadsheets and extensive process flow documents to conduct risk assessments for hundreds of products, a process that was proving to be complex and cumbersome. Read More
Solution	The company engaged Sphera’s centralized risk management solution to streamline data capture and risk assessment across its portfolio. The company introduced Sphera’s Advanced Risk Assessment (ARA) solution as a centralized risk management tool. The solution helped the company create an end-to-end process, including multiple interacting templates, that connected requirements to PHAs, FMEAs, and related control strategies. The initial rollout began with over 500 users in five countries, who used the newly centralized risk management process to ensure quality and share best practices throughout the product lifecycle. The company also began using ARA to evaluate complaint severity and allocate resources accordingly. Based on its positive experience, the company plans to continue to expand usage of ARA into more countries and sites to continuously improve their quality processes. Read More Log in to view content
Contents

Technology Category

Application Infrastructure & Middleware - Data Exchange & Integration

Applicable Industries

Pharmaceuticals

Applicable Functions

Quality Assurance

Use Cases

Regulatory Compliance Monitoring

Root Cause Analysis & Diagnosis

Services

System Integration

Challenge

The global pharmaceutical company was facing challenges in managing quality risk and reducing product defects. The transition from conventional to biopharma drug production had made compliance more complex and traceability crucial. The company was using spreadsheets and extensive process flow documents to conduct risk assessments for hundreds of products. This process was complex, cumbersome, and difficult to query. The elements of the process were not clearly linked, making the investigation of complaints burdensome and expensive. The company was dealing with disparate risk assessment processes across more than 62 countries, using time-intensive, manual reporting tools, and had an ineffective complaints analysis process.

About Customer

The customer is one of the world's largest pharmaceutical companies, with patient safety and regulatory compliance as their top priorities. The company has a global presence, operating in over 62 countries. It generates a revenue of $22.3 billion and employs over 33,000 people. As the company transitions from conventional to biopharma drug production, it faces increasing complexity in compliance and traceability. The company was using spreadsheets and extensive process flow documents to conduct risk assessments for hundreds of products, a process that was proving to be complex and cumbersome.

Solution

The company engaged Sphera’s centralized risk management solution to streamline data capture and risk assessment across its portfolio. The company introduced Sphera’s Advanced Risk Assessment (ARA) solution as a centralized risk management tool. The solution helped the company create an end-to-end process, including multiple interacting templates, that connected requirements to PHAs, FMEAs, and related control strategies. The initial rollout began with over 500 users in five countries, who used the newly centralized risk management process to ensure quality and share best practices throughout the product lifecycle. The company also began using ARA to evaluate complaint severity and allocate resources accordingly. Based on its positive experience, the company plans to continue to expand usage of ARA into more countries and sites to continuously improve their quality processes.

Impact #1	Consistent, centralized risk data
Impact #2	Significant time-savings with digital risk reporting tools
Impact #3	Streamlined data capture leading to better complaint analysis and resource deployment

Impact #1

Consistent, centralized risk data

Impact #2

Significant time-savings with digital risk reporting tools

Impact #3

Streamlined data capture leading to better complaint analysis and resource deployment

Benefit #1	Saved millions of dollars streamlining the complaint investigation process
Benefit #2	Reduction in product defects and costly recalls

Benefit #1

Saved millions of dollars streamlining the complaint investigation process

Benefit #2

Reduction in product defects and costly recalls

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Overview

Reduce Quality Risk and Streamline Regulatory Processes

Operational Impact

Quantitative Benefit