Electronic Reporting with PV-Works
PV-Works implements electronic reporting of drug safety data in full compliance with ICH E2B.
PV-Works enables electronic submission of adverse event data to Regulatory Authorities in accordance with their rules, expectations and formats.
The PV-Works electronic reporting functionality is maintained in line with all regulatory changes as they occur.
PV-Works E-reporting functions
PV-Works offers more than the ability to export adverse event data into the appropriate format:
- Full processing of acknowledgment messages sent by the recipient is integrated into a tracking module within PV-Works thus allowing customers to monitor electronic submissions and respond to any warning or failure messages
- Integration with any gateway software - Assured can recommend suitable software but does not mandate one particular brand
- Import of adverse event data received from Regulatory Authorities or Licensed Partners
- Creation of XML files in a batch process allowing generation of larger submissions based upon query results
- Flexible mapping of value lists which may be used in your business for internal reports whilst maintain compliance with the values mandated by authorities for electronic reporting
- Extension of the electronic reporting model to include Licensed Partners and other third parties such as call centres
- The function can be extended to include third party formats