FileTrail’s new e-Signature Module provides electronic signature capture to comply with a 21 CFR Part 11 requirement. This is a documentation requirement that is important to Pharmaceutical and Medical Instrument companies. The e-Signature Module is integrated into FileTrail’s configuration engine. It allows configuration of which types of transactions require an electronic signature, and whether a reason code or textual explanation can be entered. Additionally, each a witness electronic signature can be configured as optional or required for each type of transaction.
The initial electronic signature, reason, and witness electronic signature are captured and displayed in item history. They also appear on an audit report for presentation to internal and external auditors.