Preconditions
for Electronic Signature21 CFR Part 11 and 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.
Electronic Signatures allow you to protect raw data in a data system provided that these signatures are accepted in the same way as traditional signatures. In 1997, the FDA provided the basis for this by establishing the Electronic Records and Signature Rule known as "21 CFR Part 11." According to this rule, electronic signature means "the 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."
If User Mode is enabled, Chromeleon allows you to electronically sign the results generated from your 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 your results.
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 more information about electronic signature, refer to:
Preconditions
for Electronic Signature
Signing Sequences Electronically
For information on Chromeleon's compliance with the 21 CFR Part 11 law concerning data security and digital signatures please refer to Technical Note 54 – Using Chromeleon Chromatography Management Software to comply with 21 CFR Part 11. This document is also available on the Thermo Fisher Scientific website (www.thermofisher.com).