ONE RIMS
To comply with ISO IDMP standards, as required by Commission Implementing Regulation (EU) No 520/2012 (Articles 25, 26) (2), the European Medicines Agency (EMA) offers four SPOR data management services. For centralized management of SMS, PMS, WHO & RMS data.
What is ONE RIMS?
This is a practical tool that supports the management of product dossiers and regulatory information, the preparation of product submissions and the management of product regulatory information in the approved formats.
RIMS is ready to send data directly to the EMA (PMS) to comply with the legislation.
The most important in the installation RIMS is that the companies will need to collect more data, earlier in the process.
ISO IMP STANDARDS
- Substances ISO 11238
- Regulated medicinal product information ISO 11615
- Pharmaceutical dose forms, units of presentation and packaging ISO 11239
- Regulated pharmaceutical product information ISO 11617
- Units of measurement ISO 1124
Why contracting ONE-RIMS to QbD Group?
Redefining standards through innovative solutions, ensuring quality, and paving the way for your unparalleled success. Choose more than a supplier; choose a dedicated partner in your journey to excellence
The XEVMPD Maintenance Services will be obsolete and replace by this new maintenance in this RUM and will ensure regulatory compliance and data quality
Unlock cost savings by choosing us over direct supplier contracts. Our efficient processes deliver quality with affordability. Optimize your investment with our streamlined solutions
Installation process, migration, maintenance, communication with the EMA, etc. No customer support will be required as the information is already included in the GAP analysis
Contact us
Contact us for more information or to request a free, no-obligation proposal.
