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Pharmaceutical Industry: Process Improvement / Pharmacovigilance / Quality Complaints

Capability

Regulatory, Compliance & Quality

Client

A major generic pharmaceutical company

Problem

Inefficiencies in pharmacovigilance processes were causing redundant work and quality complaints. Given a long-range forecast for increased volume, the company wanted to streamline processes in order to scale up the organization‘s capacity while reducing the need for additional headcount and maintaining a high level of compliance.

Approach

Tunnell performed a four-week operational excellence assessment, including the mapping of as-is processes, analysis of value-added activities, calculation of required headcount to handle current and future volume, and examination of existing SOPs to verify the level of compliance against regulatory requirements. As a result, Tunnell recommended that the company:

• Redesign the intake process to eliminate redundant activities
• Eliminate low-value data collection and analysis not required by regulation
• Redesign the peer review process to increase the level of compliance
• Eliminate redundant hand-overs in processing ‘combo’ AE/Quality cases
• Implement auto-population of correspondence generated by the system, reducing labor time and potential errors
• Streamline the flow of cases through the system, reducing number of touches in each case
• Modify enabling technology platforms to improve productivity and increase the quality of data and responsiveness

Results

Tunnell’s solutions enabled the company to:

• Reduce headcount by 45%
• Maintain the ability to handle current and projected volume
• Increase the level of accuracy and compliance

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