Electronic Signature

According to the "21 CFR Part 11" rules and regulations published by the FDA in 1997 electronic signature means the "a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature".

Use the Electronic Signature feature in Chromeleon to sign and thus, to protect the results generated from your Raw Data. This is an important aspect for quality assurance and GLP. When User Mode is enabled, you can sign and protect Sequence reports that have been accepted as correct. In this way, it is possible to review and reproduce the results at any time later.

Electronic signature includes three steps:

• Submit

• Review

• Approve

Typically, the user who created the report signs and submits it. Afterward, for example, the laboratory manager reviews the report and signs it as well. Finally, the quality assurance manager approves the results.

 Tips:

Enable User Mode. If User Mode is disabled, electronic signature will not be possible. Besides, electronic signature is available only for user databases that have been created with a User Manager (CmUser program) version 6.10 or higher. Update your database if an error message notifies you that electronic signature will not be possible.

If you use the sample Types Spiked and/or Unspiked, please keep in mind that:

• An Electronic Signature created with Chromeleon 6.50 or earlier is invalid in Chromeleon 6.60 or higher.

• An electronic signature created with Chromeleon 6.60 or later is invalid in Chromeleon 6.50 or earlier.

For information about how to sign reports electronically, refer to Creating and Managing Files and Data  Signing Sequences Electronically. Also, refer to  Chromeleon User Management in the Administrator Help section.