Regulatory Affairs Document Archive and Retrieval System
Single Source of Truth for Regulatory Correspondence
RADARS
The Regulatory Affairs Document Archive and Retrieval System (RADARS) is an archive solution which provides the ability to track regulatory communications with health authorities.
By logging and tracking official submission records, incoming correspondence, and other forms of communications from health authorities such as emails, phone calls, and letters, RADARS can provide a complete chronology of interactions for a particular product, drug application, specific topic, or timeframe.
This powerful and quick metadata-driven approach provides for instant retrieval of records and their associated electronic documents including digitized paper records.
RADARS allows consolidation of multiple systems and storage locations, combining file shares with other EDMS and tracking databases with spreadsheets into a single centralized location for all the information about a product.
Features
Compatible with all browsers. RADARS supports and is compatible with most modern browsers, such as Chrome, Edge, Firefox, and Safari. Its compatibility puts IT managers in control of the deployment, and allows end-users choice/Preference.
Single source of truth. Record content can be linked to any archive location, such as a file share or Electronic Document Management Systems, to preserve the corporate’s “Single source of truth” paradigm. You can also configure the system to centrally archive documents by uploading the documents to managed by the RADARS solution as your new single source of truth. This approach allows for a versatile management strategy by separating your work-in-progress documents from final and fit-for-user versions.
Metadata-driven records and content management. The metadata-driven search offers a customizable set of metadata index elements for the search form, allowing users to streamline and enhance their search process to find the most relevant records. Users can tailor the metadata elements according to their specific needs, resulting in more precise and relevant search outcomes.
Integrated eCTD capabilities. The product deeply integrates with eCTD, making record creation straightforward with automated indexing and document classification of eCTD submissions. These eCTD submissions are readily viewable in either full lifecycle eCTD Viewers, providing a comprehensive, easy-to-use interface for accurately managing and viewing eCTD data.
Secured. Access controls in our product, enabling administrators to set permissions at various levels such as country, product, and document classification. This allows for granular control over access rights, reinforcing security measures while ensuring that relevant parties have appropriate access.
Data integrity through master data management. The Master Data module equips the system with a consistent vocabulary, thus enhancing its controllability and ensuring data accuracy and consistency across the platform. In addition, it offers fully configurable procedure types, record types, and additional metadata, providing users with a high degree of customization to suit their unique workflow needs.