Using PKS™ Reporter

Electronic Signature of Reports

PKS™ Reporter supports electronic signatures of reports, facilitating compliance with FDA regulation 21 CFR part 11. The author of a report can set up a list of users required to sign to the report.

The list may include any PKS users with read-level or higher access rights to the PKS study associated with the report. A table which will hold the signatures can then be placed in the report. The list of signatories, and the signature table, become part of the report document.

When the report is ready to be signed, the signers use PKS Reporter's signature tool to electronically sign the report and (optionally) to notify the other signers of the signature. The electronic signature is recorded in the PKS. It includes the report and version being signed, and the following items based on US FDA 21 CFR part 11 regulations:

• the first name, middle initial, and last name of the signer
• the meaning of the signature
• the date and time of the signature

Each electronic signature in PKS Reporter is valid for only the specific version of the report that was signed. If a report is edited after it has been signed, the new, edited version will not inherit signatures from the prior version.

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