Audit Readiness with DrugCard
How We Help You Stay Audit-Ready
DrugCard is designed to support both MAHs and CROs in maintaining inspection-ready pharmacovigilance literature monitoring processes.
“There was a request to show whether the platform found a specific article on a specific date. Thanks to the filtering, we found it and showed it immediately.”
– Vladyslav Vesna, QPPV, Farmak, Ukraine
Data Integrity and System Audit Trail
DrugCard provides full transparency of pharmacovigilance activities by maintaining clear visibility of all monitored literature sources, including historical data. All user actions that may influence screening and assessment outcomes are recorded in a comprehensive system audit trail, clearly documenting who performed each action and when.
Traceability of Search Strategy and Reproducibility of Results
The platform enables clear documentation of how literature monitoring is conducted, including the applied search strategies and keywords. Search results are consistent and reproducible over time, allowing organisations to demonstrate that literature monitoring is performed in a controlled and methodologically sound manner. This supports clear and defensible explanations during regulatory inspections.
Documented Monitoring Periodicity
DrugCard provides documented evidence of the defined frequency of literature monitoring and confirms that monitoring activities are performed in line with agreed schedules. This removes reliance on manual tracking mechanisms and supports clear demonstration of ongoing compliance during inspections.
Documentation of the Monitoring Process
In addition to final outputs and reports, DrugCard documents how the literature monitoring process is performed. This includes screening decisions, categorisation steps, quality checks, and internal review activities.
Record Integrity and User Activity Control
To support data integrity requirements, DrugCard ensures the integrity and immutability of records.Records within the system cannot be edited or deleted, and all user interactions are captured through controlled system logs, allowing verification of user activity at any point in time.
Business Continuity and Source Availability
To ensure continuity of the literature monitoring process, DrugCard securely stores reviewed literature articles within the system. This ensures continued access to monitored content even if the original external source becomes unavailable, reducing operational and compliance risk.
Validated System and Quality Oversight
DrugCard operates as a validated system supported by an internal system validation team and established validation and change-control processes. The platform is maintained under an internal Quality Management System aligned with GxP principles, supporting consistent system oversight and controlled evolution.
Audit Support Services
In addition to the platform itself, the DrugCard team supports organisations throughout the inspection lifecycle. This includes pre-audit consultations and preparation, guidance on how DrugCard processes address typical inspector questions, and support during audits, including assistance in responding to inspector requests.
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