Increase Safety Case Management Efficiency by Integrating with Leading Safety Systems
Pharmacovigilance case assignment can pose significant operational challenges, particularly when multiple Marketing Authorization Holders (MAHs) are involved, each with their own safety systems. Below are some of the challenges that can arise in this scenario:
Data Management Challenges: One of the most significant challenges of having multiple MAHs and safety systems is managing the data from these systems. The data may be stored in different formats, and there may be a need to integrate data from different sources to ensure that a complete picture of the case is obtained.
Duplication of Efforts: Another challenge that can arise is duplication of efforts when multiple MAHs are involved. This can occur when each MAH conducts its own investigation into the same safety issue, leading to redundant efforts and potentially delayed identification of safety signals.
Communication Challenges: Effective communication is essential for successful pharmacovigilance case management, and this can be difficult when dealing with multiple MAHs and safety systems. There may be differences in terminology and processes between the different systems, leading to confusion and delays in case management.
Resource Allocation: Having multiple MAHs and safety systems can place a significant burden on resources, including staff, budget, and IT infrastructure. Allocating resources to manage cases across multiple systems can be challenging, and it may be necessary to prioritize cases based on their potential impact on patient safety.
Regulatory Compliance: Compliance with regulatory requirements can be challenging when multiple MAHs are involved. Each MAH may have its own obligations under local regulations, and it may be necessary to navigate different regulatory frameworks when managing cases across multiple jurisdictions.
Introducing Compier ICSR Management
Compier ICSR Operations provides digitalization and automation of case assignment along with insights on the case and user progress. Cases can be auto assigned to users thereby reducing the manual work of a workflow manager.
Solution Features & Benefits
- Eliminate lengthy, redundant and error-prone process in assigning safety cases to global PV team members
- Managers can perform periodic reconciliation of cases’ statuses and re-assign cases for speedy processing
- WIth Compier, decision makers can assess their team’s productivity and efficiency with operational insights
- Simplify the overall case processing effort when Pharma companies have more than one MAH configured
- Gain visibility on case processing outcomes with connected communication and historical tracking
- Stay informed on reporting delays and other issues that could result as findings during audits and inspections
Solution FAQs
We offer the Compier ICSR Management solution using the Software as a Service (SaaS) model with a standard Service Level Agreement (SLA). Additionally, Techsol shall also provide professional services to complete the successful implementation, configuration, validation, and global rollout of the Compier Aggregate Reporting system along with the required system integrations.
Compier ICSR Management is a GxP regulatory compliant software system that fulfills FDA’s 21 CFR Part 11 and EU Annex 11 requirements. Techsol will provide the complete IQ/OQ validation documentation during the time of system implementation.
Our subject matter experts will deliver a hands-on Compier ICSR Management application training to your application champions by using ‘Train-the-trainer’ approach. Trainings will be delivered primarily through web conference using standard presentations.
The Compier ICSR Management solution architecture is designed to support various types of system integrations to eliminate manual effort and facilitate stakeholder collaboration across different PV business functions for increasing quality, compliance, and productivity.
The system supports a wide range of external system integrations using RESTFUL APIs and file-based data exchange transactions. Our approach towards integrations with third party solutions is based on industry standards, web services, APIs, and open architecture-based solutions.
