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Freyr RIM Process
Freyr’s RIMS system, SPAR, is based on ISO guidelines recommended for IDMP. The data elements derived from ISO standards are well-drafted to be a comprehensive RIMS system. Freyr SPAR is better equipped to manage complex RIMS requirements than legacy data structure-based RIMS. Freyr possesses RIMS data expertise and can work with an organization on IDMP data collection, collation and cleaning exercise.
Freyr SPAR software has a flexible and scalable architecture. It can be easily integrated into an organization’s Regulatory systems with connectors and adaptors that can exchange data/documents to form a seamless, comprehensive RIMS ecosystem. Once into the organization’s Regulatory ecosystem, Freyr would work with the organization for a possible futuristic RIMS system, moulded as per the organization’s requirements.
Freyr is an end-to-end Regulatory services provider engaged in developing software solutions for all Regulatory functions.
Freyr RIMS Expertise
- Data cleansing/Data entry in 3rd party Regulatory & Compliance software and other Custom-software of Bio-Pharma companies
- Design & development of quick, agile & validated software tools and accelerators that interface with multiple systems to provide required information
- Regulatory Data Management services with well-defined SOPs and audit-trail
- Custom report design and development for compliance needs
- Regulatory data quality checks
- Addition of metadata to Regulatory documents and Regulatory DMS
Freyr RIMS Features
- Reduces effort and timelines to obtain Regulatory compliance concerning products and Regulatory organizations
- Delivers clear oversight of lifecycle compliances
- Effectively manages the post-submission queries raised by Health Authorities
- Helps manage commitments, variations and obligations easily
- Tracks marketing authorization and lifecycle applications
- Tracks dossiers for variation in products and Regulatory organizations
- Tracks variations, reviews of records and product information
- Accomplishes Regulatory mandates of electronic systems, such as 21 CFR Part 11
- Improves efficiency and collaboration with increased speed and quality of the submission