21 CFR Part 11 Compliance for Spreadsheets: Use-Cases, Insights and Reviews | 2024 Cuspera

Spreadsheets must have a digital signature feature that includes a cell-level audit trail, security for individual cells, sheets, and the entire file, and electronic signatures. The electronic signature must contain the signer's identification and printed name, the date and time the signature was created, and the meaning of the signature. Electronic signatures should be configurable to match the specific needs of each application.

Spreadsheet workflow management capabilities can meet 21 CFR Part 11 compliance requirements. They can manage documents electronically, including review and approval processes, which can reduce the need for manual tasks. These systems also help organizations track and manage data, ensuring the integrity and security of information.