This client is one of the leading Pharmaceuticals Company; an integrated, publicly listed organization with a focus on supplying affordable, quality products both in India and International markets. They have been in this business for 4 decades now with growth spiking up to 12 manufacturing plants which are managed centrally from the head office in Mumbai. To maintain quality across all these plants, a virtual system was what they desired for.
Apart from the extension of consistent quality standards for all plants across, it was getting difficult to maintain paper-based records. Considering paper-based quality management, it was getting difficult to maintain traceability of dependent quality events. Records were routed as per the flow defined in SOP and manual signatures were to be taken at every stage of creation, review and approval.
During audits, a lot of time was taken up searching for documents. Not only that, but there was a challenge to not being able to present compliance with transparency.
Updating progress on documents was time consuming. Further, timely review and approval of records required lots of effort, eventually increasing follow-ups and the consumption of more time.
To Edge out these hassles, they wanted a customized and complete paperless digital solution. One that is fully compliant, improves audit readiness, generates powerful reports and provides notifications to follow up for smooth communication. Mostly, all Department users play an active role in maintaining quality events in the system. Ensuring enterprise-wide quality systems was a priority.
QEdge EQMS by Sarjen Systems – An Enterprise Quality Management System was demonstrated to showcase how quality events, documents, training and audits were interlinked across the organization to ensure quality compliance.
Initially, our team suggested a model based on the URS shared. While understanding the URS, we faced some comprehension issues since a few terminologies used by client and industry standard practices were different. On critiquing, we understood that this was made after evaluating a few vendors since there was inconsistency in the language and format. We took an approach of preparing a DS based on our understanding and getting it approved by client. This approach worked but still there were some gaps that we needed to fill. We went onsite to meet the client, understand and together update the URS in detail.
For the client, the priority was convenience. They have a team who works with a particular structured process and methodology which is unique to them. The challenge was to convince the client through consultation of a particular requirement to cater differently than the URS since it was pre-approved, and signature of all plant heads cannot be taken again. We took a second visit to the site to get a detailed understanding of their workflow and processes. We came back and sat with the product team to discuss how we can customize those requirements for the current solution.
We believe in the value of time. Due to the back and forth on understanding, we lost time and to cover up, team stayed back on holidays to ensure delivery of project.
QEdge eQMS solution helped in optimizing the operation work up to 70 % with the overall efficiency of Quality Process.
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.