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Seamless management of crop protection product dossiers
All regulatory submissions start their life as a series of discreet documents and metadata. These are formed into a structured submission before being validated, published, and transmitted to the authorities. This is a long and complex process involving many different individuals, working with many forms of content, using a variety of systems, over an extended period of time.
Needless to say, working together on these can be incredibly complex and time consuming. To ensure compliance within the highly regulated crop sciences industry you need a solution that enables your organization to create and maintain compliant submissions across a number of products, within multiple geographic markets. EXTEDO’s PlantOS is an off-the-shelf solution designed to meet these needs and ensure effortless compliance with the latest regulatory requirements.
- Compliance with latest crop protection industry regulations
- Ability to validate and publish submissions from a single application
- Improves cro protection submission quality and consistency
- Supports for regional submission structures and formats (e.g. CADDY-xml, ePRISM, eIndex) from around the world
- Supports parallel work from multiple users
- Supports global management of crop protection dossiers
- Ensures a secure environment to submit virtually
- Minimal hardware requirements, rapid deployment and system validation, high performance and minimum training
A comprehensive electronic submission management solution
PlantOS provides you with a complete regulatory dossier assembly and submission management solution. Using PlantOS, you can build, view, validate and publish compliant submissions based on CADDY, ePRISM, eIndex and other regional standards.
Its scalable, all-in-one submission management capabilities meet the requirements for both electronic and paper submissions, while its configurable design enables PlantOS to be adapted to suit the internal business processes of your organization. Existing business and regulatory processes can be mapped out and, where required, additional metadata can be included.
PlantOS is a collaborative tool enabling your users to work simultaneously on a single submission. Through this approach, the time required to compile submissions is reduced and higher quality submissions can be created in a shorter timeframe. By enabling full-text search within documents, variables and table of contents, PlantOS enables you to quickly locate and navigate to specific documents. While sophisticated audit trail and archiving capabilities allow quick access to the full change history of dossiers.
Standards-based submissions can be generated automatically within PlantOS – its internal validation capabilities ensure that submissions comply with the latest regulatory requirements and the process of generating reports is automated.
User-friendly, highly secure & integrated solution
The PlantOS interface is intuitive and user-friendly, ensuring ease of adoption amongst users. It is quick and easy to install and requires minimal administration. Deployment to end-users can be as either a desktop installation or through a terminal server instance.
PlantOS is also a well-integrated solution that can be configured to use various Document Management Systems (DMS), like EMC Documentum or Microsoft Sharepoint. Content can be easily dragged and dropped from any repository (DMS or desktop) directly into your electronic submission.
User management capabilities within PlantOS are also highly sophisticated. Administrators can add, delete and manage individual permissions for users, ensuring a highly secure environment for your submission management process.
PlantOS is the most cost effective solution for building, validating and publishing electronic submissions, ensuring effortless compliance with regulatory requirements within the crop science industry.
Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.
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Education & Training Services
To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOsuite solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics.
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