Trackwise Drug Safety Software
An increasing trend of adverse events, drug safety problems, and drug withdrawals in the pharmaceutical and biotechnology industries is driving companies to take an integrated approach to product safety, quality, and pharmacovigilance risk management. FDA, EMEA, and other health authorities expect organizations to eliminate data silos and create a continuous process for managing clinical and post-market events, adverse event reporting, data analysis and risk management functions.
TrackWise: An End-to-End Drug Safety System
TrackWise drug safety software enables pharmaceutical and biotechnology companies of all sizes to reduce product safety risk, achieve compliance, and improve efficiency of pharmacovigilance processes. It’s a fully web-based drug safety system that allows organizations to accurately and efficiently record events, conduct analysis, and report adverse events to appropriate health authorities. TrackWise is industry-proven to meet complex and global regulatory requirements and is used worldwide by more than 100 pharmaceutical and biotechnology customers with hundreds of thousands of end users.
Holistic Approach to Complaint Management & Drug Safety
TrackWise is the only product safety software tool on the market that offers a fully integrated, enterprise complaint management and drug safety system. It enables your organization to manage and track customer call triage, complaint investigations, and CAPA planning execution and follow-up, as well as safety and reportability assessments and adverse event reporting. A fully automated workflow engine enforces consistent and compliant case management process steps and reduces adverse event reporting delays. Workflow processes are fully configurable to meet both the business and regulatory compliance needs.
Comprehensive Adverse Event Coding & Reporting
TrackWise software is fully compliant with international regulations and guidelines supporting case management, report preparation and electronic submissions. It ensures accurate and effective documentation, coding, assessment and reporting of adverse event and supports current standard dictionaries including MedDRA and WHO DRUG. It generates all applicable regulatory reports including both individual cases and aggregate reporting.
Safety Analysis, Signal Identification and Surveillance
TrackWise improves risk management by automating safety, surveillance and signal identification processes. Flexible search tools and integrated reports provide extensive trending and visual representation of key performance indicators related to product safety risk via intuitive and informative management dashboards.
Fully Configurable to Meet Changing Needs
International safety and pharmacovigilance regulations as well as internal business initiatives and changes may require updates to your processes and systems. Implementing changes to data dictionaries, report formats, or other requirements does not require new software versions. changes are fully audit trailed as required by 21 CFR Part 11.
Centralized System with Global Capabilities
TrackWise’s flexible architecture enables companies to meet both global and local reporting processes and report formats. The user friendly interface supports any local language, including multi-byte languages like Japanese. The system also supports universal time code normalization, local data formats, and unlimited security roles to meet your organization’s specific business needs.
Experience in Your Industry
Sparta Systems has been a trusted solution provider of enterprise quality management software solutions to the pharmaceutical and biotechnology industries since 1999. We are committed to your industry and have earned a reputation for proactively addressing changing industry needs. In addition to a scalable and flexible software solution, our professional services organization offers unmatched experience in implementing enterprise solutions for organizations of all sizes.
