Close
Founded in 2013, the company provides expert consulting in drug development and safety, focusing on best practices in manufacturing, controlling, and distributing medicinal products. They support regulatory compliance and enhance patient health globally, offering services like notification/registration of food supplements and regulatory services for medical devices. As a local PV responsible person for Portugal, they have a top credit rating and a presence in multiple countries, including Croatia, Kosovo, and Albania. Known for their excellent price-to-quality ratio, easy communication, and high flexibility, they are highly trusted by clients, consistently exceeding expectations. So, they wanted a digitized quality management system
Managing documentation manually and ensuring traceability, particularly for tasks such as change control and SOP management, was tedious and challenging.
They required audit-ready data and needed to increase the level of operational activity smoothly.
Ensuring compliance with regulatory standards and maintaining accurate records manually was challenging and time-intensive.
To address these challenges, the organization wanted a customized and paperless digitized quality management Software, specifically for CAPA, change control, and SOP management. The solution aimed to improve audit readiness, generate flawless reports, and provide notifications to follow up for smooth communication.
Our team began by thoroughly understanding the User Requirement Specifications (URS) to ensure the solution met all client needs.
We requested their current version of SOP, conducted a gap analysis, and evaluated how our application matched their needs. A demonstration based on this alignment was provided.
The client needed specific adjustments at the field level to align with their SOP. We gathered data for field-level setups and prepared a Design Specification (DS), ensuring clarity in each field.
After finalizing the DS, we configured the application and validated the system. This included rigorous testing, both unit and user acceptance testing, to ensure the application worked correctly and met regulatory requirements.
Client satisfaction and competitive advantage, strengthening their position in the pharmaceutical consulting industry.
Continuous improvement initiatives with QEdge’s analytics and performance metrics, enabling the identification of areas for continuous improvement through KAIZEN.
Dependence on manual processes.
Adaptability to specific needs, even with minimal user profile requirements and compliance objectives.
Reduced risk and strengthened data security and risk management practices.
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
Contact Us
6th Floor, Arista, 100 Feet Anand Nagar Rd, Jodhpur Village, Ahmedabad, Gujarat 380015
Phone : +91-79-66214899
Email: sarjen@sarjen.com