PERIODIC SAFETY REPORTS (PSUR/PBRER/PADER/LOCAL)
Aggregate reports planning, scheduling, authoring and distribution processes within organizations are manual, 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 complicate 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 a 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 aggregate reporting process from automated scheduling/planning to automated authoring, distribution and submission tracking of reports. It can generate compliance metrics for the leadership on the fly. The solution integrates regulatory knowledge base, company product portfolio, company’s safety database and internal company business processes to provide a centralized system and repository for aggregate reporting. It provides organizations proactive decision making capabilities and compliance indicators to help reduce overall reports and to ensure regulatory commitments are met on time in a cost effective manner.
Benefits
Ready to automate your periodic reporting (PSUR) processes?
REQUEST DEMOKey Features
- Manage end-to-end aggregate report process including planning, scheduling, report generation and submission tracking.
- 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.
- Ensure conformance to standards, templates and regulations.
- 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
- Generate reports on variance in expected timelines and actual timelines for different levels of management.