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A globally recognized pharmaceutical manufacturer with a presence in over 60 countries aimed to enhance operational efficiency and get quality manufacturing while expanding its production facilities. Specializing in a wide range of therapeutic segments, including antibiotics, cardiovascular, CNS, and oncology, the company is known for producing high-quality generics and adhering to stringent international regulatory standards such as USFDA, UK MHRA, and EU GMP.
Expansion into new markets and manufacturing capabilities revealed the limitations of the current system, highlighting the need for a more advanced digital infrastructure.
To support increased capacity, an upgraded platform with automation and AI was essential for streamlined processes and effective decision-making.
A scalable system was necessary to ensure seamless integration across expanded operations, enabling consistent data flow and improved cross-departmental visibility.
To support the expansion with quality manufacturing and address these operational requirements, the company chose to upgrade to the latest version of QEdge. The enhanced features offered by QEdge enabled the company to maintain regulatory compliance while optimizing its quality management operations on a larger scale.
The project team defined the upgradation scope with stakeholder collaboration, allocating resources and establishing a timeline that aligned with the expansion goals. Specific challenges in data processing, reporting, system performance, and user management were identified as primary areas of focus.
Enhanced Data Processing: Implement an integration platform to facilitate seamless data transfer between applications, ensuring efficient inter-application communication and productivity.
Streamlined Processes: Develop a centralized repository for quality processes across manufacturing sites, enabling better control, faster decision-making, and improved operational transparency.
System Scalability: Upgrade infrastructure and optimize system architecture to handle increased transactional loads, utilizing cloud solutions and load testing to prevent performance bottlenecks.
Conducted user acceptance testing (UAT) to validate the new features and ensure they aligned with existing workflows. Feedback was used to refine the system, and the go-live plan was executed to ensure a smooth transition.
Enabled the system to handle larger operational demands with improved speed and efficiency.
Enhanced workflows allowed the expanded facility to operate at optimal productivity.
Real-time data access facilitated quicker, more strategic decisions across facilities.
Improved data flow between applications ensured smooth, synchronized operations across the expanded infrastructure.
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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6th Floor, Arista, 100 Feet Anand Nagar Rd, Jodhpur Village, Ahmedabad, Gujarat 380015
Phone : +91-79-66214899
Email: sarjen@sarjen.com