Vigipx is an E2B ICH R3 Global Safety Database for the electronic processing of individual case safety reports (ICSRs).
Vigipx is a fully validated Database and FDA 21 CFR Part 11 Compliant, hosted on Oracle Database, using Oracle services to meet the world's highest security and data protection measures.
Vigipx is a fully validated ICH E2B Database and MedDRA integrated, it is Ideal for collected safety information processing, and it facilitates the reporting of safety reports to authorities and third parties in XML format, supported by case validator and audit trail. Insight provides each client with a dedicated safety database to ensure full segregation and confidentiality of data. The web-based interface enables clients to securely access their database remotely.
Vigipx imports your XMLs generated from other systems to manage all your cases more smoothly in one place with an automated duplicate check function ensuring the accuracy of the record of your case.
Vigipx Database complies with the highest standards of backup best practices, the Database backup is performed on a daily basis.
Database Location: Oracle® Frankfurt Data Center – Germany
Vigipx has an Automated literature search function with more than 50 international and local resources (Health Authorities and Journals) with extra tools to facilitate the literature screening process.
Vigipx is extremely user-friendly and supported by data analysis tools for complex information transforming them into simple data such as line listing and summary tabulation for each product with a signal detection tool.
our service includes comprehensive training for your team to ensure efficient use of the database.
Contact us today to discover how we can help you enhance your pharmacovigilance operations and ensure compliance with global regulatory standards.
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