Seamless Connectivity to
Various products, several markets, merged with varied Regulatory requirements challenge Life Sciences companies to secure and preserve broad range of information in order to obtain Health Authority (HA) approvals. Additionally, the data generated to sustain the product lifecycle, supply chain and constantly changing market requirements would also multiply the Regulatory information management complexities. Since the inception of regulations, heaps of Regulatory data has been and is till date, controlled in silos, across the globe. Finding data in a single location remains a significant challenge. The constantly updated regulations, demand for global formats and upsurge of data requirements question the methods in which Regulatory information is being managed.
A next-gen advanced Regulatory Information Management System (RIMS) - Freyr SPAR (System For Products And Registrations) optimizes the Regulatory submissions process, accelerates time-to-market, helps better process integration and unifies information at a single location, which is accessible from any part of the world in a single click. With technologically advanced architecture integrated with ever-evolving Regulatory standards, Freyr SPAR maintains information – from tracking product registrations, marketing authorization lifecycles, product data, Regulatory document management, HA interactions, to generating reports with a zero-footprint viewer.
Freyr SPAR Expertise
- End-to-End Registration Lifecycle Management – Variations, Renewals, Commitments and Obligations
- IDMP Ready
- Ability to Integrate with EDMS, eCTD Submissions Publishing, Labeling Change Tracking, XEVMPD, IDMP, SPL, etc.
- Unified Repository for All Documents
- Customizable Reports and User-specific Dashboards
- Wizard-Based Record Creation Handle Multiple Products
- Application Types and HA Requirements
Freyr SPAR Features
- Simple and effective workflow with an option to draft, review and approve records
- Manage and access metadata with a few easy clicks
- Designed as an integrated yet independent repositories for products, devices, documents
- Freyr SPAR has been built based on the standards of ISO
- Highly customizable and a robust report can be configured based on the customers’ requirements
- Application can be accessed using a browser over the web
- User interface is very intuitive and easy to understand and navigate
- Software has powerful search filters, which would help a user to search and navigate to a specific record