Good Products and Adlib Software Partner to Facilitate
Pharmaceutical Regulatory Submissions
(24 September, 2008) Good Products, a leading provider of Enterprise
Content Management (ECM) solutions for the pharmaceutical,
biotechnology and medical device industries, and Adlib Software, a
leading producer of server-based document conversion, recognition
and publishing software, today announced an OEM partnership. This
new partnership has been formed to facilitate regulatory submissions
in the pharmaceutical industry and will see the integration of Good
Products' electronic document management system (eDMS) g-docs with
Adlib Software's Express Server centralized PDF rendering tool.
The collaboration between the two industry-leading scientific
software providers addresses the need from the pharmaceutical
industry for streamlined and compliant regulatory document
management. Using the new integrated system, pharmaceutical
organizations will be able to store, manage and track regulatory
documents and create high quality regulatory submission-ready PDFs
with bookmarks and hyperlinks.
g-docs from Good Products offers life sciences organizations an
effective, easy-to-use way of managing their documents including
tracking document version history, managing approvals, monitoring
and recording changes in an audit log. Additionally, g-docs
incorporates CoSign, a digital signature solution that allows an
individual to digitally sign a document as if they were using ink.
CoSign digital signatures have now been upheld in the US court, and
are deemed to pass the 'non- repudiation' test as well as being
compliant with the FDA's 21 CFR part 11 Guidance. g-docs uses Adlib
Express Server to automatically convert different document formats
including Microsoft Office, scanned images, engineering drawings and
web and image formats to PDF while meeting the requirements of
international regulatory bodies, including the FDA. g-docs also uses
Adlib to automatically maintain audit, version, reference and
distribution tables within the rendered documents, massively saving
time and at the push of a button.
Peter Duff, president and CEO, Adlib Software, comments: "Our
partnership with Good Products complements the ability to provide
compliant document conversion systems to the pharmaceutical
industry. The integration of g-docs and Express Server accelerates
regulatory submissions and enables organizations to manage documents
in a compliant way across the whole lifecycle, from creation to
regulatory submission."
"With the increasing standardization of regulatory submissions in an
electronic format, and the need to simplify the User experience,
both Adlib Software and Good Products recognize the importance of
maintaining the consistency and accuracy of electronic documentation
from creation to submission," adds Keith Williams, CEO, Good
Products. "We are now looking to work together to develop further
enhancements and functionality, enabling deeper integration of Good
Products and Adlib Software solutions."
Article available at:
http://www.pharmiweb.com/PressReleases/pressrel.asp?ROW_ID=4640
http://www.scientific-computing.com/news/news_story.php?news_id=630