PhRISMA’s Regulatory Information Management System (RIM) manages regulatory requirements across involved business processes.
PhRISMA is an extremely powerful, flexible and versatile information platform designed to handle the whole spectrum of Regulatory Information Management across the pharmaceutical enterprise. The system will help you to increase compliance, improve control, reduce risk, reduce costs, decrease time-to-market and increase flexibility.
Today, the focus on regulatory compliance is stronger than ever in the pharmaceutical industry, and the landscape of business is changing more rapidly than ever before. In this constantly changing environment, companies need to be able to quickly adapt to new circumstances, while remaining in compliance. But how do you make the right business decision to achieve regulatory compliance and operational excellence in this increasingly complex environment?
PhRISMA recognises that companies are having difficulties answering these questions as the answers are mostly embedded in the organisation and its departments. Despite the fact that there is an increased demand to share information between departments (RA , Supply chain, Production, QC, QA), most IT systems have difficulties with linking the information of the whole business process. PhRISMA helps you to make the right business decisions and achieve compliance by integrating IT systems.
- Application procedure management
- MA portfolio management and licensing tracking
- Logistic – RA synchronized business processes
- Alignment of Central and or Local organized RA departments
- Business decision support – regulatory compliance
- Extensive standards complaint reporting xEVMPD
- Labeling and packaging changes