CIMdata PLM Industry Summary Online Archive
26 November 2007
Implementation Investments
Open Text Announces Completion by Jazz Pharmaceuticals, Inc. of FDA Electronic Pilot Submission Using Livelink ECM - Collaborative Submissions
Open TextT Corporation announced that Jazz Pharmaceuticals, Inc . has successfully completed its pilot submission to the U.S. Food and Drug Administration (FDA) using Open Text's Livelink ECM - Collaborative Submissions. This initial step is required to ensure that an electronic submission in the eCTD (Electronic Common Technical Document) format can be prepared according to published guidelines and successfully received by the FDA prior to the January 1, 2008 deadline.
Livelink ECM - Collaborative Submissions is designed to manage and support the assembly, review, approval and release of large document sets (submissions) made to government regulatory agencies around the world that are responsible for drugs, biologics and related products. The comprehensive Livelink ECM - Collaborative Submissions solution manages documents through their lifecycles and reduces time-to-market by enabling companies to prepare and make submissions in the industry's standard eCTD format.
Developed by the International Conference on Harmonization (ICH), the eCTD was designed to be a common format for company-to-regulatory agency transfer of information and is acceptable across the United States, Japan, the European Union and Canada. However, since the eCTD is still an evolving standard, with a number of different interpretations and region-specific guidelines, the FDA established the pilot submission process to certify the technology platform used for eCTD submissions.
Like many pharmaceutical companies today, Jazz Pharmaceuticals, Inc. has embraced the eCTD format as a way to improve its regulatory processes. Using Livelink ECM - Collaborative Submissions, Jazz Pharmaceuticals prepared and sent to the FDA a very sophisticated pilot submission that was composed of more than 500 documents, including SAS-format statistical information, supplied in native form; the FDA's required Study Tagging File (STF); and the FDA's Structured Product Labeling (SPL). In addition, the company provided several hundred PDF links between the submitted documents.
The pilot submission was thoroughly verified by the FDA and passed with no issues.
"We selected Open Text's Collaborative Submissions for our eCTD submissions because we wanted a tightly integrated solution to our Livelink ECM document management system," said Lynn Ferguson Lewis, Project Manager, Information Technology, at Jazz Pharmaceuticals. "We are very pleased that our pilot submission was confirmed by the FDA."
"Being able to submit documents according to the FDA's rules is obviously a business-critical issue for any pharmaceutical company," said John Wilkerson, Executive Vice President of Global Sales, Services and Support at Open Text. "The team at Jazz Pharmaceuticals planned ahead and has deployed a solution that has worked well for a successful pilot submission that met regulatory guidelines. The success at Jazz Pharmaceuticals validates the work we've done in the life sciences industry, with customers and partners, to create solutions that are addressing the latest compliance requirements from the FDA and other regulatory agencies around the globe."
Livelink ECM - Collaborative Submissions offers life sciences companies a single, end-to-end system to help manage eCTD-compliant submissions to the FDA, the European Agency for the Evaluation of Medicinal Products (EMEA) and other regulators worldwide. The solution combines documents, forms and records management software, content publishing tools and the ability to automate a wide range of processes, from ad hoc to tightly sequenced workflows. Integrated tools such as check-in/check-out, version history, event auditing, signing controls, alternate renditions and compound documents make it easy to manage documents, their constituent documents and related components to ensure accuracy.
For more information about Livelink ECM - Collaborative Submissions, go to: http://www.opentext.com/2/sol-industry/sol-ind-pharma/sol-ind-pharma-collaborative-submissions.htm
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