FDA Laboratory Information Bulletin 4524

FDA Laboratory Information Bulletin 4524

The FDA publishes an internal Laboratory Investigation Bulletin (LIB) each month that is distributed to all FDA employees. It contains articles written by FDA employees that describe methods, procedures and products that a site has used that have demonstrated a high degree of success or an improvement over an existing method. The goal of these articles is to promote best practices to other sites within the agency. In the June 2012 issue, the San Juan District Laboratory released a Laboratory Information Bulletin 4524 detailing their experiences with ExcelSafe.

The San Juan District Laboratory investigation showed that ExcelSafe improved the analytical spreadsheet’s application’s data integrity, security and template accountability by using electronic signatures, audit trails, and other compliance and tracking features. Using ExcelSafe improved laboratory efficiency by decreasing the time required for internal document review. They praised the ease of using ExcelSafe, noting that ExcelSafe had produced significant cost and time savings, and stated they would continue to use ExcelSafe.

Download a copy of Laboratory Information Bulletin 4524 “Evaluation of ExcelSafe to Implement Part 11 Rules in FDA Analyst WorkBook Files”