Regulatory Intelligence Management

  • Over the last decade, regulatory agencies worldwide have gradually developed regulations and laws to regulate drug development processes in a consistent manner. As more counties adopt these practices there is a large set of rules and regulations that are both global and local in a constant state of evolution and change. Organizations currently do not have a centralized process to manage tracking, maintaining and distribution of the various rules and regulations. The current processes utilize a combination of tools, external system and websites to collate the information. This process is manual, error-prone involving repetitive work with a high degree of risk and non-compliance. As the scale of operations grow, the potential for delays, errors, or loss of communication of critical information increases.

    Quartica’s solution can help organizations manage global and local regulations worldwide in a centralized collaborative system. Organizations can manage up-to date information with history of changes and ensure all stakeholders within the company have access to the latest information. The system also provides country based roles access allowing individual countries to update and publish their regulations set.
  • One stop shop to manage worldwide regulatory agencies regulations and guidelines.
  • Support to track internal company policies and guidelines.
  • Interactive map based view color coded based on strength of regulation in the country.
  • Re-use meta-data, fields and data across globally.
  • Version history to track all changes and effective documents.
  • 21 CFR Compliant with built in audit trial, security and confidentiality protocols.
  • Manage regulatory intelligence information in a collaborative centralized repository.
  • Automate existing manual process using the workflow and roles based access to individual countries.
  • Automate distribution of updates and changes in real time to all stakeholders.
  • Track PRAC activities along with milestones and dates in various countries.
  • Generate reports and metrics to determine change in regulations, strongly vs. not strongly regulated countries, PRAC activities and others.
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Compliance ready by Design

Roles based access control

Audit Trail and Life cycle traceability

Personalized user experience

Cost effective

Easy to deploy and mantain