Streamlining Pharma Compliance

The Challenge

Pharmaceutical manufacturing companies face the daunting task of establishing comprehensive quality management and compliance systems that meet a multitude of legal requirements. They must maintain standardized operating procedures (SOPs) that legally cover all processes and procedures. Traditional compliance tasks involve not only publishing internal policies and training materials but also managing complex regulatory frameworks. This process is labor-intensive, requiring employees to manually compare and update documents—a task that can take several days.

The Use Case

A Compliance Manager and Qualified Person in the pharmaceutical industry sought to create a highly efficient compliance management system. Using the Libra platform, she developed a custom AI-powered Pharma Agent to tackle these challenges. The Pharma Agent checks documents against complex regulatory frameworks and provides user-friendly, immediate solution suggestions. This significantly reduces the workload, saving up to 85% of the time that quality assurance staff would otherwise spend manually reviewing documents and replacing outdated or incorrect sections.

In the area of Good Manufacturing Practice (GMP), the Pharma Agent also assists in creating audit day plans and audit reports, considerably reducing preparation time. Additionally, it offers an AI-powered GMP knowledge database that supports legal inquiries and compliance matters, reviews and creates SOPs, and prepares audits.

Libra’s Solution

The Pharma Agent is a specially developed AI assistant built on the Libra platform. It performs thorough analyses based on over 300 legal foundations and numerous iterations of regulations. Trained to recognize methodological approaches, identify relevant passages, and compare documents with applicable guidelines, the Pharma Agent efficiently structures and accelerates the entire compliance process.

How Libra Streamlined the Workflow

• Automated Document Review: The Pharma Agent scans and analyzes documents against complex regulatory frameworks, identifying discrepancies and providing immediate solution suggestions.

  
  

• Significant Time Savings: By automating the comparison between old and new regulations, the workload is reduced by up to 85%, allowing staff to focus on more strategic tasks.

  
  

• GMP Audit Support: Assists in creating audit schedules and reports, reducing preparation time and ensuring compliance with GMP standards.

  
  

• AI-Powered Knowledge Base: Provides a comprehensive GMP knowledge database for legal questions and compliance issues, supporting the creation and review of SOPs and audit preparations.

The Results

Implementing the Pharma Agent through Libra led to substantial benefits:

• Reduced Workload by Up to 85%: Automation of manual comparison tasks saved significant time and resources.

  
  

• Enhanced Accuracy: Thorough analyses based on relevant laws and guidelines minimized the risk of human error.

  
  

• Improved Efficiency: Compliance processes became more streamlined, facilitating quicker adaptation to regulatory changes.

  
  

• Better Resource Allocation: Employees could focus on higher-value tasks, improving overall productivity.

Conclusion

By leveraging Libra's platform, the pharmaceutical company transformed its approach to compliance management. The AI-powered Pharma Agent not only saved time but also elevated the quality and accuracy of their work. This solution is transferable to any field requiring alignment with extensive regulatory frameworks.

For more information or specific questions about the Pharma Agent, please contact our team.