The Electronic Signature option enables you to create a more secure environment by requiring that operators electronically "sign" for all database process changes resulting from data entry and alarm acknowledgement. Electronic signatures uniquely identify the operator making the change, and can optionally require the electronic signature of another person to verify the change. Operators no longer need to use paper and pen to record and sign for their actions, and the possibility of losing or damaging such records is essentially eliminated.
More detailed permanent records of operator actions are now written to and stored in a relational database. You can query and report on these records, and then use this data to provide a comprehensive audit trail detailing the history of your process. The electronic signature audit trail provides greater versatility than paper trails. You can query and analyze data quickly and conveniently. Additionally, record tracking through electronic signatures increases security for process changes and alarm acknowledgements.
You can easily upgrade existing applications to take advantage of this functionality. None of your pictures need to be modified. A simple change to the tags in the Database Manager allows you to implement the Electronic Signature option. For more information, refer to Configuring Electronic Signatures.
Electronic signature capability also helps address the needs of iFIX users who must conform to the 21 CFR Part 11 United States FDA government regulation. Using the feature by itself does not ensure compliance; however, applications built using the Electronic Signature option can help provide the necessary electronic verification needed to satisfy the requirements of this regulation. See Understanding 21 CFR Part 11 for more information.
