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Calyx RIM License Modules

The Calyx RIM® modules enable different organizational roles and functions within the regulatory lifecycle of a drug product. Each module focuses on one particular area of expertise and includes the ability to control access permissions within the module for specified users and groups.

By assigning access permissions to users or roles, you can enable some users to merely observe or access queries and summaries while enabling others to perform the daily operations of project management, research, planning, and publishing.


Available Modules	Description
Calyx RIM Workflow Integration	Enables you to utilize client-specific workflows that contain multiple activities, with dependencies and preset fields, that guide processes within the system.
Calyx RIM for XEVMPD	Enables you to capture, maintain, and submit data about pharmaceutical products to comply with the Extended EudraVigilance Medicinal Product Database (XEVMPD) directive.
Calyx RIM for Analytics	Enables you to generate reports about Calyx RIM activities. These reports include dashboard reports, predefined reports, guided ad hoc reports, and ad hoc reports (which you define from scratch). Note: This module includes the Calyx InSight Dashboard module, but you can have InSight Dashboard without the rest of the Analytics module.
Calyx InSight Dashboard	Provides analysis reports of key performance indicators. Dashboard reports provide senior management with an at-a-glance perspective of the current status of a product, unlocking the business value of Calyx RIM data. Viewing Calyx InSight Dashboard reports, senior managers can quickly understand the current product posture, enabling rapid and informed business decisions. Note: This module is included in the Calyx RIM for Analytics module, but you can have InSight Dashboard without the rest of the Analytics module.
Registration Planning and Tracking	(RPT) enables you to plan registration activities and collect registration data without product formulation details. It improves affiliate communication, enables you to track the status of overall global product registration activities, and maintain product registration compliance.
Product Detail Management	(PDM) enables you to track product formulation and SPL exports. It also provides queries about where products are registered and other registration information.
Submission Planning and Tracking	(SPT) enables you to create, review and track submissions from planning to publishing. It also automates assembly creation and enables you to monitor the authoring process.
Registered Document Analysis	(RDA) leverages lifecycle submission information to enhance the DMS repository for better decision support based on usage information. It enables you to query for the external approval status of documents and to perform impact analysis of registered document changes.
Electronic Lifecycle Publishing	(ELP) simplifies eCTD creation and is required to publish assemblies as eCTD submissions.
Paper Review Publishing	(PRP) enables you to build assemblies for publishing to paper. PRP enables you to add paper elements such as TOCs, cover pages, overlays, and cross references to electronically published submissions suitable for generating study report submissions, hybrids, and other electronic submission formats. Using both the ELP and PRP licenses enables you to add these publishing elements to eCTD lifecycle submissions. Finally, PRP also enables you to publish an entire assembly to a single file electronically.

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Calyx RIM License Modules

The Calyx RIM® modules enable different organizational roles and functions within the regulatory lifecycle of a drug product. Each module focuses on one particular area of expertise and includes the ability to control access permissions within the module for specified users and groups.

By assigning access permissions to users or roles, you can enable some users to merely observe or access queries and summaries while enabling others to perform the daily operations of project management, research, planning, and publishing.


Available Modules	Description
Calyx RIM Workflow Integration	Enables you to utilize client-specific workflows that contain multiple activities, with dependencies and preset fields, that guide processes within the system.
Calyx RIM for XEVMPD	Enables you to capture, maintain, and submit data about pharmaceutical products to comply with the Extended EudraVigilance Medicinal Product Database (XEVMPD) directive.
Calyx RIM for Analytics	Enables you to generate reports about Calyx RIM activities. These reports include dashboard reports, predefined reports, guided ad hoc reports, and ad hoc reports (which you define from scratch). Note: This module includes the Calyx InSight Dashboard module, but you can have InSight Dashboard without the rest of the Analytics module.
Calyx InSight Dashboard	Provides analysis reports of key performance indicators. Dashboard reports provide senior management with an at-a-glance perspective of the current status of a product, unlocking the business value of Calyx RIM data. Viewing Calyx InSight Dashboard reports, senior managers can quickly understand the current product posture, enabling rapid and informed business decisions. Note: This module is included in the Calyx RIM for Analytics module, but you can have InSight Dashboard without the rest of the Analytics module.
Registration Planning and Tracking	(RPT) enables you to plan registration activities and collect registration data without product formulation details. It improves affiliate communication, enables you to track the status of overall global product registration activities, and maintain product registration compliance.
Product Detail Management	(PDM) enables you to track product formulation and SPL exports. It also provides queries about where products are registered and other registration information.
Submission Planning and Tracking	(SPT) enables you to create, review and track submissions from planning to publishing. It also automates assembly creation and enables you to monitor the authoring process.
Registered Document Analysis	(RDA) leverages lifecycle submission information to enhance the DMS repository for better decision support based on usage information. It enables you to query for the external approval status of documents and to perform impact analysis of registered document changes.
Electronic Lifecycle Publishing	(ELP) simplifies eCTD creation and is required to publish assemblies as eCTD submissions.
Paper Review Publishing	(PRP) enables you to build assemblies for publishing to paper. PRP enables you to add paper elements such as TOCs, cover pages, overlays, and cross references to electronically published submissions suitable for generating study report submissions, hybrids, and other electronic submission formats. Using both the ELP and PRP licenses enables you to add these publishing elements to eCTD lifecycle submissions. Finally, PRP also enables you to publish an entire assembly to a single file electronically.