labelBridge: Features and Specifications
labelBridge is a Java J2EE application, accessed via Web browser: no client software is required other than a current version of Microsoft Internet Explorer or Mozilla Firefox.
labelBridge works with Oracle (v9+) or Microsoft SQL Server (2000+). Document content is primarily stored in the database, but labelBridge can be customized to store content in a discrete Content Management System (e.g. Documentum) if desired.
labelBridge is also available as a service offering via labelBridge.ASP™. Organizations can have access to all labelBridge features without having to install the system on their own equipment. This solution is optimized for smaller and distributed compliance teams, and can be ready for use in a matter of days.
labelBridge can be deployed on a stand-alone basis, or as a complement to LORENZ’s suite of products, such as the docuBridge™ Submission Management System.
1. Document Management
- Allows management of an unrestricted number of Listings, GDUFA Self Identification forms, Establishment Registrations and NDC Labeler Code Requests, organized into customer-defined "Projects" (e.g. by document type, by product line, by active ingredient, etc.).
- Includes supporting descriptive and tracking information, such as Approval status (internal and regulator), version status, read-only status, validation status, etc.
- Allows import of SPL files. This import can be from a local source, or SPL files downloaded from the National Library of Medicine's DailyMed system.
- Supports additional site-specific data fields via system configuration file to support proprietary organizational requirements. These fields can have basic validation constraints (e.g. pre-defined drop-down lists, simple data-typing) and can optionally trigger appropriate system actions (e.g. audit, workflow).
2. Content Preparation
- The narrative text content of each Listing is managed and edited at a granular level (e.g. Sections, and Product Data Elements) to support integration into a compliant regulatory document without requiring authors to understand arcane XML structures or to memorize ever-changing code lists. The document components are assembled effortlessly, allowing authors and reviewers to easily examine the complete document in an intuitive way.
- Narrative text components are edited using the included browser-based WYSIWYG editor.
- Fielded content such as SPL Product Data Elements are presented in a forms-based interface. This is supported by context-sensitive help including links to both relevant Guidance documents and/or customer specific documentation.
- Individual information components can be easily copied to allow information re-use.
- Legacy SPL R4 content can be imported, and automatically transformed to SPL R5 syntax. Non-SPL content can be pasted into the XML Editor with formatting intact.
- Integrated guidance messages help authors minimize the possibility of entering invalid data.
- FDA mandated code and terminology lists integrated directly into labelBridge and kept up-to-date.
- Built-in Validation engine provides report of all warnings and critical errors that should be addressed prior to publication and submission of the document.
- Content state transition model can be configured to allow or disallow publishing of any document that contains even a single error.
- The labelBridge Validation engine checks all FDA requirements (i.e. ELIPS rules) and provides messages linking back to these requirements.
4. Annotation & Review
- The Annotation sub-system allows commentary on entire documents or major sections, via references to XML constructs in the SPL file. The document remains SPL-compliant with no proprietary markup added.
- Optional a Side-by-Side comparison tool available, which highlights differences between any two document versions.
- Content state transition notifications can be e-mailed to stakeholders. For example, an email can be sent to the Product Manager of a given Product that a sign-off has occurred.
- Quick Review provides a WYSIWYG view of the content using the FDA's style sheet. Review Mode displays the formatted document, combined with unobtrusive editing and annotation controls.
5. Export & Publishing
- Export can be done at most points in the document lifecycle and in a variety of formats including XML, PDF, HTML, and RTF (for use with MS Word).
- Files can be exported for direct submission to the FDA via the Electronic Submission Gateway (ESG) and for third-party validation.
- SPL document can be exported as browser-viewable preview version (to distribute to stakeholders who do not have direct labelBridge access).
- labelBridge Publishing is an auditable event in the life-cycle which cannot occur unless the document has passed any and all process/control requirements.
- labelBridge is designed to meet 21 CFR 11 requirements by, for example, having strong user authentication, role-based security, records management and activity auditing.
- Flexible user access privileges model provides the facility to restrict access to Projects, both for security reasons and for the added benefit of increased efficiency (users only see what they need to see).
- All changes to content are audited. Where relevant, audit entries allow a user comment to be included which is stored with the audit entry.