Technical Considerations for the Validation of Electronic Spreadsheets for Complying with 21 CFR Part 11

January 1, 2003
Tuan T. Phan

Tuan T. Phan is president of Validation Associates, Inc.

Pharmaceutical Technology, Pharmaceutical Technology-01-01-2003, Volume 27, Issue 1

Bridging the gap between compliant spreadsheet production and limitations in available technology can be achieved by the use of custom-created electronic solutions.