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A leading pharmaceutical and biopharmaceutical company based in Eastern Europe, the client is known for its commitment to developing high-quality medicinal products across multiple therapeutic categories. With growing regulatory expectations and operational expansion, the company recognized the need to evolve its digital infrastructure for quality and training management.
Despite using electronic systems across departments, the lack of interconnectivity posed operational and compliance challenges.
Various quality processes like change control, CAPA, and deviations were managed in silos, making traceability and follow-ups difficult.
Teams had minimal centralized access to document status, training progress, or quality event stages, leading to information gaps.
Manual sign-ins, lack of role-based learning paths, and no deadline tracking made training management inefficient and hard to scale.
Meeting audit and regulatory expectations became harder without a unified audit trail or cross-functional collaboration.
Complex and overly customized workflows caused delays in adoption, with users struggling to manage updates and document versions.
To address these issues, QEdge was implemented to bring structure, visibility, and compliance into one unified platform.
QEdge’s implementation brought immediate structure, efficiency, and reliability to their processes.
Users now access quality events, training progress, and document workflows from a single, centralized platform.
Features like e-signatures, audit trails, and automated documentation support regulatory readiness with minimal manual effort.
Self-learning modules are now completed on time, thanks to automated reminders and clear completion tracking.
Quality events like CAPA, deviations, and change control follow predefined, risk-based workflows to reduce errors and delays.
Dashboards and KPIs give teams and leadership instant insights into training gaps, overdue actions, and audit preparedness.
Thanks to automated reminders and deadline enforcement.
Real-time traceability of training records and quality events simplified inspection prep.
Version control ensured the latest SOPs were in use across teams.
Linked workflows and alerts kept all actions tracked to closure.
Electronic sign-ins, auto-certifications, and dashboards reduced manual workload.
With QEdge, bring all the quality processes such as Change Control, Deviation, Investigation, CAPA, Market Complaints, OOS, OOT, Risk Assessment and other quality related activities like SOP management, Training management, Audit management, Vendor qualification and PQR/APQR on a single platform.
Experience a Digital Transformation journey with a trusted automation and digitization partner. To start, email us at sarjen@sarjen.com or visit qedge.sarjen.com.
Sarjen Systems has been serving the Pharma & Life Science industry for the last 25 years. We keep updating our products on a regular basis to serve our customers with products that are compliant. Our products are greenfield products and technologically updated as per requirements.
QEdge Quality Management Software Suite
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Phone : +91-79-66214899
Email: sarjen@sarjen.com