Sharon Forder, ESPS
44 1753 725203
[email protected]
FOR IMMEDIATE RELEASE
ESPS Launches DAMOS Software Module at IBC Common Technical Document Conference
London ñ April 5, 1999 ñ ESPS, Inc. (Electronic Submission Publishing Systems, Inc.), a leading, global developer of electronic compliance (e-compliance) management solutions, today announced at the IBC Common Technical Document (CTD)/Electronic Submissions Conference the addition of the DAMOS Compilerô module to its flagship compliance software product, CoreDossierÆ. Since its introduction in 1995, CoreDossier has been setting the standard for electronic regulatory and business compliance publishing. It enables organizations to efficiently assemble, manage and publish the large volume of information necessary in regulatory submissions and other mission-critical documents.
ìThe key to success for the pharmaceutical and medical products industries is to implement strategic solutions that address the ever-changing regulatory environment,î said Robert Kuller, director, global pharmaceutical and medical device markets at ESPS. ìChanging product registration regulations, progress towards global data harmonization and evolving electronic submission standards make bringing products to market increasingly complex and costly for these organizations.î
The DAMOS Compiler is specifically aimed at helping pharmaceutical and medical products companies fulfill their regulatory requirements when electronically submitting required documents to regulatory agencies worldwide. DAMOS, the acronym for Drug Application Methodology with Optical Storage, is a TIFF-based international standard for exchanging dossiers between pharmaceutical companies and certain drug regulatory agencies. For instance, it is currently used extensively at BfArM in Germany.
ESPS Launches DAMOS Software Module at IBC Common Technical Document Conference
ìThe DAMOS Compiler meets the DAMOS 3.0.1 electronic submission specification. According to this specification, an electronic submission consists of primary document content in TIFF format, metadata in a specific ASCII structure and CD-ROM for optical media storage. There are also provisions for inclusion of supporting documents in native file format,î explained Katia Musitu, european regulatory compliance manager at ESPS.
Use of CoreDossierÆ with the DAMOS Compilerô to create DAMOS-compliant submissions offers companies numerous benefits, including:
o Eliminates need to develop custom DAMOS compilation tool or use service provider.
o Provides intuitive user-interface of dossier structure and content for effective submission assembly.
o Provides data entry windows to capture DAMOS-specified dossier information.
o Verifies DAMOS-specified data formatting requirements at time of entry.
o Creates a DAMOS table of contents with depth and automatic structure numbering options.
o Allows authors or publishing managers to assign cross-references and position them on
evolving document.
o Allows users to attach supporting files with minimal effort.
o Provides user-defined page stamps for easier paper and electronic submission navigation.
o Accesses studies and reports from shared file systems and multiple document management systems.
o Manages the collection of audit trail information pertaining to dossier changes for post-marketing amendments (with subsequent release).
o Determines number of required CD's and organize pages, supporting files, and metadata files across CD's appropriately.
o Adapts to more than 100 source file formats, including TIFF for scanned legacy documents and older versions of various authoring tools.
o Produces exact TIFF format specified by the DAMOS Format Specification.
o Produces the metadata file formats specified by the DAMOS Format Specification.
o Shelters registrants from reacting to the changes of DAMOS Format Specification, since it will be continually updated to meet evolving pharmaceutical electronic submission specifications.
About ESPS
ESPS, Inc. (Electronic Submission Publishing Systems, Inc.) is a global leader in the development and implementation of enterprise-class software solutions used to manage and publish regulatory compliance and other business-critical document collections. The ESPS flagship software product, CoreDossier®, addresses the needs of companies faced with regulatory compliance submission requirements through industry expertise, best-of-breed technology and a commitment to high-quality implementations. ESPS has set the standard for electronic-compliance (e-compliance) management in industries, including pharmaceutical, chemical, and utilities, among others. The ESPS world headquarters is located in suburban Philadelphia, with additional offices throughout North America and in Europe. More information can be found at www.esps.com, or +44 (0) 1753 725203 (Europe) or at 800.515.ESPS (North America).
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