From Fragmented to Connected: A European BioPharma Consultant’s Journey with QEdge

About Client

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.

The Hassle

Despite using electronic systems across departments, the lack of interconnectivity posed operational and compliance challenges.

Fragmented Workflows

Various quality processes like change control, CAPA, and deviations were managed in silos, making traceability and follow-ups difficult.

Limited Visibility

Teams had minimal centralized access to document status, training progress, or quality event stages, leading to information gaps.

Training Disruptions

Manual sign-ins, lack of role-based learning paths, and no deadline tracking made training management inefficient and hard to scale.

Compliance Pressure

Meeting audit and regulatory expectations became harder without a unified audit trail or cross-functional collaboration.

Workflow Overload

Complex and overly customized workflows caused delays in adoption, with users struggling to manage updates and document versions.

Edging out with QEdge (EQMS Solution)

To address these issues, QEdge was implemented to bring structure, visibility, and compliance into one unified platform.

GxP-compliant audit trails across training and quality events
Centralized SOP repository with version control
Role-based training assignments using Job Codes
Automated training schedules with reminder alerts
On-the-job and instructor-led training with biometric sign-in
Integrated Change Control, CAPA, and Deviation workflows
Real-time dashboards and analytics for training & QMS status
SCORM-based interactive training and certification generation

Tackling the Challenge

QEdge’s implementation brought immediate structure, efficiency, and reliability to their processes.

Unified System Access

Users now access quality events, training progress, and document workflows from a single, centralized platform.

Improved Compliance Tracking

Features like e-signatures, audit trails, and automated documentation support regulatory readiness with minimal manual effort.

Deadline-Driven Training

Self-learning modules are now completed on time, thanks to automated reminders and clear completion tracking.

Standardized Workflows

Quality events like CAPA, deviations, and change control follow predefined, risk-based workflows to reduce errors and delays.

Real-Time Visibility

Dashboards and KPIs give teams and leadership instant insights into training gaps, overdue actions, and audit preparedness.

Explore our Enterprise Quality Management Solution and Book a Demo for free today!

Digital Transformation Business Impact

0 %

Reduction in Training Follow-Ups

Thanks to automated reminders and deadline enforcement.

0 %

Audit Readiness

Real-time traceability of training records and quality events simplified inspection prep.

SOPs Always Up-to-Date

Version control ensured the latest SOPs were in use across teams.

Zero Missed CAPA Follow-Ups

Linked workflows and alerts kept all actions tracked to closure.

0 %

Time Saved in Training Administration

Electronic sign-ins, auto-certifications, and dashboards reduced manual workload.

About QEdge

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.