Electronic Signature

During the last decades, quality assurance and GLP have become increasingly important. Data verification is one of the key aspects. That is why it is especially important to ensure that Raw Data is not modified later. In addition, the results generated from this raw data must not be modified without authorization once they have been accepted. Contrary to a data system, printed records can ensure this in part only.

If User Mode is enabled, Chromeleon allows you to electronically sign the results generated from the raw data. This is an important aspect for quality assurance and GLP. Electronic Signature allows you to sign and to protect Sequence reports that have been accepted as correct and thus, to 'freeze' the current state of the results.

 Note:

Electronic signature is only available for user databases created with a User Manager (CmUser) program version 6.10 or later. Update your database if an error message notifies you that electronic signature is not supported.

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.

For information about how to sign reports electronically, refer to Creating and Managing Files and Data  Signing Sequences Electronically.