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Sunday, August 30, 2009
Grand Hall/Exhibit Hall
Building the Foundation for an Electronic Quality Management System via a COTS Implementation
Introduction
The Laboratory Response Branch (LRB) within the Division of Bioterrorism, Preparedness and Response (DBPR) has developed the foundation for a robust electronic Quality Management System (QMS) by successfully implementing a COTS product to address several core QMS functionalities. The LRB Electronic Quality Management System (LRB EQMS) provides LRB with document management, complaints management and corrective action/preventative action (CAPA) management.
Challenges
Previously, LRB had a shared-drive based document management system which presented challenges to change management and version control. Moreover, complaints management was a paper-based process and a formal CAPA tracking process did not exist. The former processes were not very transparent and thus management could not determine the status of quality activities easily nor did the former process have a formal auditing mechanism for tracking changes. Finally, LRB determined that it was not feasible to build a significant IT presence within the organization to implement or maintain a custom-developed solution.
Solution
After a thorough analysis, LRB chose a COTS-based solution for the EQMS. The implementation team consisted of internal quality management and regulatory affairs experts combined with external technology and process expertise which allowed LRB to further define and improve their quality system processes. The implementation team focused on leveraging the COTS product out-of-the-box and not developing any customized code to meet the requirements. Additionally, the implementation included a full risk-based validation approach for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
Key Differentiators
· Focus on using the COTS-based solution out-of-the-box, without customization
- Retain the ability to easily upgrade to future releases of the COTS product
· Quality management and regulatory affairs experts included on implementation team to develop/further define quality system processes
· Completion of a full risk-based validation approach
Introduction
The Laboratory Response Branch (LRB) within the Division of Bioterrorism, Preparedness and Response (DBPR) has developed the foundation for a robust electronic Quality Management System (QMS) by successfully implementing a COTS product to address several core QMS functionalities. The LRB Electronic Quality Management System (LRB EQMS) provides LRB with document management, complaints management and corrective action/preventative action (CAPA) management.
Challenges
Previously, LRB had a shared-drive based document management system which presented challenges to change management and version control. Moreover, complaints management was a paper-based process and a formal CAPA tracking process did not exist. The former processes were not very transparent and thus management could not determine the status of quality activities easily nor did the former process have a formal auditing mechanism for tracking changes. Finally, LRB determined that it was not feasible to build a significant IT presence within the organization to implement or maintain a custom-developed solution.
Solution
After a thorough analysis, LRB chose a COTS-based solution for the EQMS. The implementation team consisted of internal quality management and regulatory affairs experts combined with external technology and process expertise which allowed LRB to further define and improve their quality system processes. The implementation team focused on leveraging the COTS product out-of-the-box and not developing any customized code to meet the requirements. Additionally, the implementation included a full risk-based validation approach for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
Key Differentiators
· Focus on using the COTS-based solution out-of-the-box, without customization
- Retain the ability to easily upgrade to future releases of the COTS product
· Quality management and regulatory affairs experts included on implementation team to develop/further define quality system processes
· Completion of a full risk-based validation approach