CRF Compliance

Is SharePoint 2010 a Records Management System?

In order to understand if SharePoint 2010 can be considered a Records Management System it is essential to understand what records management is. Records management is the maintenance of records within an organization, which includes security, retention, disposition, compliance, workflows. Currently many companies are using SharePoint to manage their records. Though the platform is different from traditional records management systems, SharePoint 2010 was designed with tools for managing records. Records management features included in SharePoint incorporate search tools, compliance, audit reports, retention schedules, workflows among other tools. However, many organizations are still finding the need to extend the Records Management functionality through third party vendors.

FileTrail for SharePoint fills the demand for physical records management within SharePoint. The solution integrates electronic and physical documents in document library making it easier to manage all documents through one platform. Through FileTrail for SharePoint, users can utilize the native SharePoint functionality for physical records, including built-in legal hold, retention, disposition, workflows and security. Added tools to manage physical records including current location and request retrieval allowing records managers to gain control of physical items.

The excitement surrounding FileTrail's trailblazing FileTrail for SharePoint solution has spurred a case study by Microsoft featuring FileTrail's client Black Elk Energy. Black Elk had adopted the SharePoint solution but needed to extend the capabilities for managing their multiple volumes of physical files. Read Microsoft's case study, showcasing the success Black Elk Energy has already realized through FileTrail for SharePoint.

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

San Jose, CA – August 30, 2011 - FileTrail Inc. – – 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.