How to choose a safety database: the Checklist
- Chaitali Gaikwad
- May 7
- 2 min read
Updated: May 14
Choosing a safety database is a delicate and time-consuming process, as every pharmaceutical company has unique needs. To assist in this selection, we have compiled a list of key factors to consider when choosing a pharmacovigilance database.
Requirements for Choosing a Safety Database
Regulatory Compliance: The foremost criterion is ensuring the database complies with pharmacovigilance regulations, the relevant authority, and the current electronic format, XML ICH E2B (R3).
Implementation Mode: Safety databases can be purchased or accessed via SaaS, a cloud-based leasing option. Not all providers offer both solutions, so choose one that aligns with your company's requirements.
Submitting ICSRs to Authorities: Individual Case Safety Reports (ICSRs) can be submitted via email, but using the Gateway is more efficient for large volumes. This program facilitates bulk data transmission to authorities like EMA, FDA, and MHRA.
Parameterizable Workflow: A good database should align with your company's internal procedures. Therefore, it should support customizable workflows to adhere to company-specific pharmacovigilance processes.
Safety Database Checklist
Security Requirements: The database must enable regulated access and permissions, track all activities, and maintain data integrity and privacy in compliance with GDPR.
Implementation Time: Implementing a pharmacovigilance database can be time-consuming, especially if data migration is involved. Evaluate the supplier's proposed timeline to ensure it meets your company's needs.
Validation: Computer System Validation is crucial to meet pharmacovigilance regulations. Ensure the provider offers comprehensive pre-validation documentation aligned with GAMP5 and supports the entire validation process.
Assistance: Direct assistance from the software developer is typically more effective due to their in-depth product knowledge and prompt response times compared to external management.
Maintenance: Regular maintenance is necessary to keep the database updated and compliant with regulations. Ensure this service is included in the fee.
Datacentre: The data center must have ISO 27001 certification for information security management. With GDPR in effect, data must be stored within the European Union.
MedDRA Dictionary: An integrated MedDRA dictionary with a browser for term searches is highly beneficial. The database should facilitate quick online updates in sync with the biannual MedDRA releases.
Useful Functions of a Safety Database
Advantages: A robust database should streamline pharmacovigilance activities. Essential features include:
Case preview to confirm import
Automatic duplicate case detection
Copy function to replicate case contents
Messaging and alert system for regulatory or process deadline notifications
Case agenda for recording actions and comments, with notification options
Performance monitoring reports
Business Intelligence for in-depth, immediate analysis of aggregated data.
Need help to chose the safety database? Book a FREE consultation meeting with our experts.
Comments