Aggregate reports scheduling, management and distribution processes within organizations have been fairly ad-hoc, linear and rigid utilizing a combination of localized tools, manual steps and knowledge base from individual resources. The complexity of new regulatory standards, individualized local country requirements and harmonization initiatives such as EURD further complicates the overall end-to-end aggregate reporting processes. Changing regulations in different countries, new product registrations (and withdrawals) and resource turn-over introduces tremendous challenges to organizations to ensure global regulatory commitments to agencies are met in time. The lack of centralized system or knowledge base does not offer capabilities to optimize worldwide reporting thereby increasing the overall number of aggregate reports. This increases the cost and resource needs within organizations.
Quartica’s solution can help manage the end-to-end process aggregate reporting process from scheduling to distribution and tracking of compliance metrics. The solution integrates regulatory knowledge base, company product portfolio and internal company processes to provide a centralized system. It provides automated, agile and proactive tools to organizations by reducing overall reports and ensuring regulatory commitments are met on time in a cost effective manner.
Manage end-to-end aggregate report process including planning, scheduling, reporting and tracking submissions
Generate reporting obligations worldwide based on product portfolio
Optimize reporting plans utilizing harmonization strategies to reduce total overall reports
Manage Review and Approval workflow process
Estimate resource and budget needs based on upcoming submissions and approvals
Collaborate with other departments, partners and local affiliates
Track decision log, review and approval history for complete traceability
Configure organizational specific strategies to fine tune reporting plans
Facilitate regulatory compliance of commitments to agencies on time.
Manage projects, resources and commitments by performing impact analyzes.
Monitor overall compliance, delays, CAPA and overdue reports
Generate reports on variance in expected timelines and actual timelines for different levels of management.
Determine the resource load across products and submissions.
Ensure conformance to standards, templates and regulations.
Please contact us for information or to schedule a demo