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Reduce Quality Risk and Streamline Regulatory Processes
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
The 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 The 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.
The 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.
Operational Impact
Quantitative Benefit
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