Compier Regulatory Intake
Pharma companies are required to download files from the EV Web portal and Canada Vigilance based on active substances (not based on the company’s products). Due to this regulatory change, Pharmacovigilance operations at small to mid-size companies are challenged with timely completion of review and submission of huge volumes of ICSRs. It is must for companies to include these ICSRs in the company’s centralized safety database to comply with other regulatory agencies for expedited reporting.
Common Regulatory Intake Challenges
- Manual filtering of company specific AE cases from Eudravigilance Web and Canada Vigilance database and completing ICSR intake
- Lengthy redundant and error-prone process to compile Individual Case Safety Reports (ICSRs) and finish case processing
- Users have to download multiple excel files from the Canada Vigilance database and apply filters to segregate their company data
- Poor visibility on case volume processed from these regulatory safety databases with disconnected communication and no historical tracking
- Lack of awareness on reporting delays and other issues that could result as findings during audits and inspections
Introducing Compier Regulatory Intake
Compier Regulatory Intake enables automated case filtering and ICSR intake from safety data obtained from the Canada Vigilance and Eudravigilance database. Our platform automatically reads the product information from the E2B R3 files (from EV Web) and CSV files (from Canada Vigilance) and auto-creates a valid safety case without any manual intervention.
Solution Features & Benefits
> Regulatory Intake provides various, ready to use dashboards and reports to manage the process efficiently.
> Dashboard for total cases processed in a specific time interval with details of success and non-success numbers
> Total number of cases received for a country and processed based on report type
> Multiple trend reports indicating total number of cases reported by time interval, source, product etc
> Reduces manual effort and address the regulatory compliance needs of the pharmacovigilance department.
Solution FAQs
We offer the Compier 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 Regulatory Intake 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 Intake 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 PV Aggregate 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.
