Implementation & Onboarding
How We Help You Implement DrugCard
We support your team at every step of implementing DrugCard - from initial introduction and setup to day-to-day use and ongoing support.
This structured approach ensures compliant adoption, clear user accountability, and confident use of the platform within routine pharmacovigilance workflows.
User Scope Definition
We begin by defining which users and teams will work with the platform. This includes clarifying roles, responsibilities, and access levels to ensure the system is aligned with your internal PV structure and workflows.
Initial Training by PV Experts
Our pharmacovigilance team delivers an introductory training session for your users. The training focuses on practical use of the platform within real PV processes, ensuring that users understand both functionality and regulatory context from the start.
User Account Setup and GxP Traceability
We create individual user accounts for all platform users. Each user receives personal access credentials, ensuring full traceability of actions in line with GxP requirements. This approach supports audit readiness and clear accountability within the system.
User Manual and Continuous Guidance
We provide a detailed User Manual explaining how to work with DrugCard. The manual is available directly on the platform, is accessible to all users, and is updated on a monthly basis to reflect functional improvements and process updates.
SOP Template Support
To support procedural alignment, we provide a ready-to-use SOP template, such as “Literature Monitoring with DrugCard.” The template includes embedded DrugCard workflows and a clear description of pharmacovigilance processes performed using the platform. Customers may use this document as a baseline and adapt it to their internal quality system.
PSMF Annex D and Validation Documentation
We provide a dedicated template for updates to Annex D of the PSMF (Computerised Systems and Databases). DrugCard operates within a structured validation framework, and all users have access to current and continuously updated validation documentation. These documents are available directly on the platform, supporting inspection readiness and compliance requirements.
Post-Implementation Review and Optimisation
After users have started working with the platform, we can perform a review of usage upon request. This includes checking whether the functionality is used correctly, whether key features are applied as intended, and whether search strategies and keywords are optimised. Based on this review, we provide practical recommendations to improve efficiency and monitoring quality.
Change Communication and Updates
Any platform updates or changes are communicated promptly. We provide clear and concise instructions to ensure users can quickly understand and apply updates without disrupting routine PV activities.
Support Availability and Responsiveness
Our support team is readily available to assist users when needed. We focus on fast response times and practical guidance to ensure uninterrupted and confident use of the platform.
Have questions for our experts?
Ask us about pharmacovigilance automation, literature screening or DrugCard
platform features.
platform features.
