Brighton Associates has the capability to provide in-depth reviews of a company’s Quality Operations to pinpoint opportunities for complexity reduction to improve regulatory compliance, reduce approval cycle times and improve information flows. These systems include:

• CAPA systems
• FMEA
• Raw material testing and release
• Water processing, testing and release
• Environmental monitoring and control
• Pharmaceutical manufacturing, testing and release

The reviews include:

1. Manufacturing and processing documentation, QC testing documentation, incident, exception and deviation reporting, applicable operating procedures (SOPs), and the various systems and procedures (manual and automated) used to report, track and monitor incidents that affect product release.
2. Personnel involved in each step of the process to gain an understanding of the issues and the potential for gaps to exist in your current situation.
3. Review the current CAPA program to determine how it could be expanded and strengthened to ensure that there is complete visibility of any issues that could affect product release.
4. Prepare process flow charts of the current “As-Is” process for handling of incidents, exceptions and deviations. The charts will highlight any variations from applicable procedures and gaps that could negatively impact product release.
5. Prepare process flow charts of a proposed “Should-Be” process for handling of incidents, exceptions, and deviations and ensuring the all relevant information is available in a reliable, single system.
6. Identify where actions can be taken and provide recommendations to improve performance in terms of:
   
   
   
   1. improved information availability and reliability,
   2. elimination of parallel systems for incident reporting and tracking,
   3. consolidation of procedures, information and systems for incident reporting and tracking,
   4. more effective procedures, processes and systems for incident reporting and tracking, and
   5. reduction in overall manufacturing and product release cycle times and improved product output to meet demand.