E-Signature

FileTrail's E-Signature Module Achieves Compliance with FDA Regulation 21 CFR Part 11 Requirement

San Jose, CA – August 30, 2011 - FileTrail Inc. – http://www.filetrail.com – the leading provider of physical records management solutions, today announced they have achieved compliance with the Food and Drug Administration (FDA) Regulation 21 CFR Part 11 via their e-Signature Module. The part 11 requirement defines the criteria in which electronic records and electronic signatures are considered trustworthy, reliable and equivalent to paper records. The e-Signature Module was first implemented by a global pharmaceutical company in early 2011 and the client already has witnessed dramatic benefits. By using the e-Signature Module, the pharmaceutical client has eliminated the need for a wet signature when checking out, browsing, or transferring GxP documents. The FileTrail solution as a whole has automated compliance and tracking of the pharmaceutical company’s diverse set of auditable documents and biologic samples leveraging both bar code and RFID technology. The e-Signature Module is fully integrated into FileTrail’s configuration engine and is highly configurable – allowing configuration of which types of transactions require an electronic signature and if a reason code or textual explanation may be entered. Additionally, an electronic signature of a witness can be configured as optional or required for each type of transaction. Information about the signature is displayed in the item’s history, including the initial electronic signature, reason, as well as the witness electronic signature. This information also is available in the audit report for presentation to internal and external auditors.

Read the complete press release here.

FileTrail's New E-Signature Module Provides 21 CFR Compliance

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.