CAASY

Along with our valued partners at Nexus Assurance we have developed a monitoring platform to assist you to identify and remediate any GMP compliance risks that you may have within your operation. Our platform allows you to know in real time what your compliance risks are and demonstrate that you value continuous improvement.  

Some of the advanced features of the system are:

• Risk Identification and Mitigation. The Pharmaceutical module has been built to identify any compliance risks against EU and FDA requirements. Pharmalliance would work with your team to perform an initial audit to identify any gaps which get entered into a dynamic risk register with full transparency to the issues. Depending on the risk level there can be automated escalation triggers to senior management with risk response and mitigation actions tracked within the system. 

• Enhanced Operations. Once the initial audit has been performed the ongoing compliance audits are very efficient with measurable cost reductions due to the elimination of manual reporting and gained efficiencies from remote team task management.

• Comply and Protect. As part of ongoing support we provide regulatory intelligence services to identify and manage any upcoming regulatory changes. If new changes are imminent we add the change as a task to be assessed by your team. We can then work with your team to define the best path forward to ensure that the new regulatory requirement is met. 

• Automated Reporting. The system is capable of providing automated reports to Quality Steering Committee Members to identify risks and demonstrate progress on mitigating risks. 

• Training. As part of the platform release process we provide training to internal site teams in the new system. This helps the site team understand the new system and speeds up the implementation process.   

 

We work in collaboration with your onsite team and our Quality Assurance partner to support your project implementation. Quality, compliance and project delivery are at the core of what we do. Get in contact today for a demonstration of the CAASY system.