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This client, a well-established pharmaceutical formulation manufacturer from the late ’80s, is renowned for managing specialized products with WHO GMP-approved production facilities. Their new, ultra-modern facility is designed for oral solid dosage forms and meets the latest stringent regulatory authority guidelines.
As the company expanded, managing quality events and training records on paper became increasingly challenging. The manual tracking and tracing of documents posed a risk of non-compliance.
The goal was to streamline operations, improve data accuracy, and enhance efficiency across multiple plants. They needed a solution to manage all quality events, SOPs, and training records digitally, ensuring top-level control and compliance.
To meet the company’s needs, we offered the EQMS solution, a comprehensive tool for achieving compliance and maintaining digital documents. The EQMS solution helped them manage various quality events, including Change Control, CAPA, Deviation, Risk Assessment, Investigation, Market Complaints, SOP management, and versioning, while the TMS module maintained training records.
Our project team, consisting of internal IT experts and consultants, planned to implement the solution in 12 weeks. We assessed current practices, identified gaps, conducted training programs, and ran a pilot. User Acceptance Testing (UAT) was successful, and the system integrated smoothly into existing processes with users quickly adapting.
During implementation, we faced network issues where the system didn’t allow user logins due to the same IP address for all network computers. Our infrastructure and network teams resolved this issue within a month. Strategic solutions were put in place to address and prevent potential problems.
Despite the challenges, we completed the project in 12 weeks as planned, reflecting our team’s expertise and representing a significant achievement given the complexities involved
Future scope to ensure quality management with evolving regulatory guidelines and to digitize more documents across all plants.
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