Regulatory Operations Platform Overview

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  1. FDA 21CFR11 / EU Annex 11 Compliant
  2. Audit trails & validation ready
  3. Datamart pre-configured
  4. Configurable workflows
  5. Automatic email and task handling
  6. Review and approval processes
  7. Electronic signatures
  8. Comprehensive import capabilities
  9. Powerful Output mechanisms
  10. Connects to submission gateways (lifecycle management)

Regulatory
Operations
Platform

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Regulatory Compliance

Cunesoft’s Regulatory Operations Platform has been purpose built for life sciences. It includes all necessary mechanism for compliance with FDA, EMA, GxP, ICH, ISO IDMP etc. The platform can be provisioned as Private SaaS (Software as a Service) or on-premise. Both options are implemented as validated environments.

Datamart incl. complete ISO IDMP attributes

The underlying data model includes more than 1500 life sciences specific data attributes including the entire ISO IDMP data model. Where possible, the datamart connects to external data sources for smart meta data management. Internal data sources can be connected also. Customer can personalize and extend the powerful database with personalized data attributes.

Workflows and Tasks

Process driven workflows facilitate a smooth user experience. Workflows can be easily configured by system administrators. Review and approval process as well as electronic signatures compliant to FDA or EU regulation requirements are built in functions. Email notifications can be personalized and support a seamless and fast execution of tasks.

Import and Output

The platform supports automated import procedures for eCTD’s, documents, metadata, xEVPRM messages, Excel, CSV and more. If required, a direct connection into other systems can be configured for push and pull integration. System output can be done as eCTD XML submission, HL 7 compliant IDMP submission, standard XML, JSON, CSV or XLS files.

esubmission software
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Importer

Task
management

Workflows

Datamart

Electronic
Signature

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