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This client, headquartered in Surat, Gujarat, India, is a vertically integrated manufacturer of Active Pharmaceutical Ingredients (APIs) and intermediates, founded in 2004. With over 650 employees, the company had previously relied on electronic systems but faced challenges with compliance, particularly regarding manual reminders for pending trainings. They sought a comprehensive solution to efficiently manage and assign training based on Training Needs Identification (TNI), incorporating self-paced modules for independent learning to address compliance challenges effectively.
The existing vendor provided a standardized implementation of their solution, lacking the flexibility to accommodate additional document requirements. The solution was not scalable to incorporate custom changes, hindering its effectiveness.
During audits, retrieving documents from the existing system was time-consuming and lacked transparency in compliance. Multiple records were requested, but the system was not audit-ready, resulting in inconsistencies in the records presented.
While transitioning to a digital solution improved data storage and retrieval, it failed to provide meaningful insights for informed decision-making beyond basic digitization.
To address these challenges, we showcased a customized Training Management System (TMS) designed to efficiently manage training records of offline users, thereby overcoming space constraints. The system effectively identifies training needs and analyzes gaps, while automated reminders for training completion eliminate the need for additional manpower to evaluate user quizzes, adding significant value to the solution. Our standard TMS, tailored to different roles, ensures a fully paperless and compliant approach aligned with regulatory guidelines, aiming to eliminate the hassles currently faced by the business.
Initially, our team proposed the DS approach. Understanding the existing SOPs proved challenging, requiring adjustments to address areas of improper data management.
In Phase 1, we adopted the DS approach to fulfill client requirements. This involved gathering requirements and designing a solution tailored to meet client expectations.
In Phase 2, our focus shifted to rectifying areas impacted by improper data management. This phase presented challenges and consumed considerable time as our team dedicated hours to repairing affected areas. The result was a robust system with clearly defined automated workflows. Additionally, we implemented functional updates to our training management system, including improved report formatting, provision for PDF export, and the integration of audit-specific reports.
The company experienced streamlined workflows, timely completion of training and saved hours of time for their team working on reminders of timely completion of training and evaluating the attended training of the employees. A big amount of document storage space was freed up by digitizing the data.
They generated more than 1,00,000 Training records till now.
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.
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Email: sarjen@sarjen.com