Sparta Systems enterprise quality management software (EQMS) can be used as a drug safety solution by pharmaceutical/biopharmaceutical companies of all sizes to reduce product safety risk, achieve compliance and improve efficiency of pharmacovigilance processes.
Sparta Systems’ EQMS is the only drug safety solution on the market that offers a fully integrated, enterprise- complaint management and drug safety solution that enables organizations to:
- Process safety cases
- Perform assessments and adverse event reporting
- Manage and track customer call triage and complaint investigations
- Handle all aspects of CAPA planning, execution and follow-up
Sparta Systems’ solution offers a web-based drug safety system that enables organizations to accurately and efficiently record events, MedDRA code terms against industry standard thesauruses, conduct relatedness and listedness/expectedness assessments, and report adverse events to appropriate health authorities. In additionthe solution is fully compliant with international regulations and guidelines supporting case management, report preparation and electronic submissions. The electronic reporting capabilities include flexible mapping and configuration to meet the complex and varying requirements of global regulatory authorities.
Sparta Systems has a proven track record, with more than 100 pharmaceutical and biotechnology customers and hundreds of thousands of end users around the globe.
Benefits of Sparta Systems' Drug Safety Solution:
- Track and manage the global processing of all drug safety cases
- Standardize and streamline processes for drug safety reporting to drive both operational efficiency and improved compliance
- Facilitate compliance with global and local drug safety reporting requirements through flexible workflow automation
- Support risk management programs by automating safety surveillance and signal identification processes
- Increase transparency through automated drug safety alerts and customizable reporting capabilities featuring dashboards and executive overviews
- Ensure on-time reporting of all cases for time-sensitive and periodic reporting
- Make electronic submissions and track both paper and electronic reporting via E2B