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BlueCielo Meridian FDA Module 2013 SP1 Release Notes | BlueCielo ECM Solutions |
Through release 2010, the Meridian FDA Module was a separate module for Meridian Enterprise. The Meridian FDA Module 2012 has since been re-engineered to make it more integrated with Meridian Enterprise. This integration is similar to the level of integration of the current versions of the Meridian Advanced Project Workflow Module and the Meridian Transmittal Management Module. It makes deployment easier, the user interface is more standardized, and the functionality is more seamless. Implementing the new design has resulted in some additional functionality but has also required a reduction of some functionality compared to earlier versions of the module. Support for that functionality may be restored in future releases.
A primary goal of the re-engineering of the Meridian FDA Module was to support document renditions natively within Meridian Enterprise, which is useful in other industries than just the pharmaceutical industry. A part of that support is the ability to generate the renditions using the Adobe PDF output capability of the AutoVue rendering module in the BlueCielo Publisher. That capability eliminates the need for additional third-party rendering software, further simplifying system setup, configuration, and administration.
Another result of the re-engineering is that the new version does not support all of the same features as the old module. The following table compares the capabilities of the original Meridian FDA Module to the current Meridian FDA Module.
| Feature | Old Module | New Module |
|---|---|---|
| Installation | Meridian client software installed by and with FDA Module components. | No FDA Module client software installation necessary. |
| Rendering software | Acme CAD Converter, Image2PDF Converter, bFax2PDF, PDFTools. | BlueCielo Publisher rendering modules. Requires separate BlueCielo Publisher licenses. |
| Rendition storage | Separate linked documents in separate folders. | Separate content stream of the source document like hybrid parts. |
| Configuration | Dedicated Configurator page, .ini files. | Integrated with Meridian Enterprise standard features in Configurator and BlueCielo Publisher. |
| Audit log1 | Document, rendition, security, work area, workflow events only. | Same events plus standard document, folder, hybrid, vault configuration, report, CAD link, electronic signature, and custom events. The audit log data is stored in a new, enhanced schema. A web application is provided for viewing the data with a web browser and for saving filtered and sorted audit log data as external files. |
| Security privileges | Additional for Meridian FDA Module commands | No additional privileges are necessary for Meridian FDA Module commands but additional privileges that are included in Meridian Enterprise are necessary to view and print renditions. |
| CAD external reference rules | Reference resolution and workflow synchronization warnings or enforcement. | Replaced by Meridian Advanced Project Workflow Module functionality and custom VBScript procedures. |
| Controlled copying | Copying audited, referenced files and metadata included. | Replaced by open standard format briefcases. |
| Controlled printing | One type of configurable watermark on renditions printed by viewer. | Four types of configurable, conditional watermarks on renditions generated by BlueCielo Publisher. Can include a document property value. |
| Electronic signatures1 | Can be manifested on renditions or signature pages, CAD external reference rules must be satisfied first. | Can be manifested on renditions as watermarks and on signature pages. |
| Lookup list editor | Does not require Configurator. | Not supported. |
| Workflow notifications | Configurable events, message text, CC, and hyperlinks. | Replaced by Meridian Enterprise standard features. |
| Document subscriptions | Users may subscribe to be notified upon selected events. | Replaced by Meridian Enterprise standard features. |
| User authentication1 | Authenticated with operating system, limited retries, inactivity lockout, simultaneous logon at multiple computers prevented, batch support. | Authenticated with operating system, limited retries, user name retention, default domain name, logon failure lockout, batch support. |
| Work areas | Supported | Not supported. We recommend using Meridian Enterprise project folders instead. |
| Required vault objects | Custom document types, lookup lists, pages, properties, reference types, workflow definitions, VBScript procedures. | None |
| Web Access | Supported for single documents only. User re-authentication not supported. | Full support including batch electronic signature. |
Notes:
Warning Due to the extent of the reengineering of the Meridian FDA Module 2012, it is not compatible with prior versions. Upgrading an existing installation and migrating workflows, renditions, and audit log data to Meridian FDA Module 2012 should only be performed with consultation with BlueCielo ECM Solutions Professional Services.
For more information about the features of the new version, see the BlueCielo Meridian FDA Module Configuration Guide and the BlueCielo Meridian FDA Module User's Guide.
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