To meet the requirements of EU, US and Canadian authorities the crop sciences industry has to use different standards and different technologies. A common worldwide understanding of how to submit pesticide registration application documents would facilitate the interchange of dossiers between industry and the competent authorities.
More recently, an additional standard CADDY.xml has been developed and authorised by the European Commission. It will allow better integration with the internal information system of regulatory authorities. CADDY.xml is aligned with future developments at OECD level, which go in the direction of xml-based submission templates, and will facilitate broader exchange of regulatory dossiers also in regions and countries where CADDY is not used.
EXTEDO’s off-the-shelf Submission Management System PlantOS.xml is the implementation of CADDY.xml and much more. It is a high-quality and functional product for the straightforward assembly and compilation of compliant electronic dossiers based on the standards:
and still paper
The PlantOS.xml system is an internationally applicable software solution for publishing electronic and paper-based submissions based on one single process. The general dossier structure is based on regional format templates which can be interpreted by PlantOS.xml.
› Improved dossier quality
› Reduced preparation and update time for new submissions, supplementals, amendments, etc.
› Fast access to documents for everyone who has access to the electronic dossier
› Shorter approval times which means reduced time to market
› Less paper quantity and lower logistics overhead
› Advanced archiving capabilities
PlantOS.xml is the implementation of CADDY.xml, US based PDF-submissions and Canadian e-Index. It ensures the fast and smooth functioning of a submission with the following additional benefits:
› Generation of PDF-submissions and the xml-based e-Index
› Living dossier
› Parallel work supported: in-house and worldwide
› Intuitive user interface
› Supports e- and p-publishing in one controlled process
› Powerful navigating tools: links, private and public comments, bookmarks
Structural elements can be edited, added and deleted and documents can be copied, moved or imported by drag and drop from other dossiers (DMS). Links, comments and highlights can be set at any time during compilation since documents are referenced relative to a structure element.
Once an electronic dossier has been approved by the agency, its Post Approval Maintenance Life Cycle starts which is comprehensively supported by PlantOS.xml.
PlantOS.xml has been designed as a client/server architecture allowing different users access to one dossier simultaneously. EXTEDO’s PlantOS.xml can easily be integrated into state of the art document management systems such as
Within a short time:
First Doc™, First Point™
The PlantOS.xml Suite is improved by a set of specific added value products. PlantOS.view represents the read-only application to fully access the dossier-specific submission and associated attributes. The entire retrieval capabilities are supported by PlantOS.view as well.