This client is an Indian multinational pharmaceutical company headquartered in Ahmedabad. It is a producer of generic therapeutic drugs and engaged in contract clinical research and manufacturing. It has 22 manufacturing plants, 17 in India and the rest in Greece, the United Kingdom and Mexico. With such a vast network and widespread business, it was getting complex to manage around 4000 vendors and their documents. They wanted to reduce the efforts on this and make it systematic since vendor qualification is a requirement of regulatory bodies like US-FDA, EU-GMP, MHRA, etc.
Juggling an extensive array of vendors and managing a diverse spectrum of documents, including certificates, qualification documents, and reports, posed a significant organizational hurdle, requiring meticulous attention to detail and resource allocation.
The sheer volume of documents exchanged via email related to their certificates, qualification documents, audit reports, etc. required multiple printouts and dispersed storage across repositories, which overwhelmed their existing systems, leading to inefficiencies and increased administrative burden.
Heavy reliance on inter-departmental and vendor follow-ups, compounded by the persistent issue of missing data, underscored the necessity for a more efficient and streamlined approach, prompting the client to seek a comprehensive solution to alleviate these challenges and enhance operational effectiveness.
To edge out these challenges, they aimed to shift away from complex processes and eliminate the use of Excel spreadsheets. Their goal was to shift to a smart platform offering customizable reports and third-party access.
QEdge VQM by Sarjen Systems – A Vendor Qualification System was demonstrated to showcase a mechanism where Vendors can register on their own with an access based regulation. Once Vendor Registration is done and approved, the rest process for Vendor Qualification is started which is divided into 4 levels i.e., Level I – Vendor Documents/ Certificates, Level II – Sample analysis, Level III – Trial batch Level, IV- Vendor Audit.
Automatic follow-ups are taken from the vendor and the system also notifies of document expiration and restricts permitting any further activity until a compliance report is obtained. The system automatically reminds us about the audit due dates and the schedule through the audit planner available within the system.
We assessed the client’s current process to find gaps in meeting vendor quality management (VQM) standards and developed a plan for upgrades to ensure compliance.
Working closely with the client, we customized some platform configurations to align with their processes and goals as per Pharma 4.0, optimizing usability.
Our team conducted rigorous testing, including unit and user acceptance testing, to validate platform functionality and ensure regulatory compliance especially since they used an on-premise server and the vendors were global.
Through collaborative workshops, we identified operational pain points and tailored platform solutions to automate processes, streamline workflows, and enhance decision-making capabilities.
Overall, our strategic approach addressed the client’s challenges, enabling them to achieve greater efficiency and compliance in Quality Management.
Following the deployment of our solution at the client’s site, the business experienced a paradigm shift: paper costs saw a dramatic decline, marking an unprecedented 70% reduction.
Moreover, audit readiness witnessed a remarkable surge, soaring by an impressive 60%, all attributed to the revolutionary Document Management system we implemented.
As per the data in March 2024, more than 500 API and around 2000 exp. vendors are onboarded and qualified within the system. They are expecting to touch 5000 vendors soon.
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.