How one of the large Pharmaceutical enterprise streamline and implemented quality management automation

Client background

One of the largest and fastest expanding pharmaceutical company in Bangladesh, has it’s headquarter in Dhaka (the capital of Bangladesh). Quality management automation was not a challenge with location.

This MHRA and TGA approved company involved in the manufacturing and distribution of a diverse range of pharmaceutical products, therapeutic drugs and veterinary products in various countries like Europe, Australia, South- Africa, Asia-Pacific and many more.

Business challenges

Quality management automation solution

Being a part of Pharmaceutical industry our client needs to maintain quality standards and improve it with the changing needs of customers because the poor quality of product not only a health hazard but also a waste of money and time for both government and end consumers. As an exporter our client also need to adhere the various quality standards for various countries to ensure quality, safety and efficacy.

Earlier they used to rely on manual system to maintain quality parameters but had various limitations like:

Poor allocation and utilization of resources
Lack of integration within departments and ERP
Poor flow of information affects decision making
Error prone, time and money consuming and not reliable
Poor documentation control
Poor visibility of change of control, CAPA, deviations
Inability to produce valuable business insights

Business solutions

So our client decided to upgrade the current manual system in a way that offer better
involvement of top representatives for overdue actions and critical deviations/ Change
controls and product complaints hence adopted web based QEdge- Enterprise quality
management software with cloud mobility and SAAS.

The scope of their quality management automation project was to automate and effective interlink all the
quality processes including CRF, Deviation, Investigation, CAPA, Product complaint, OOS
and OOT in a single implementation phase.

Our expert team worked very closely with them to understand their overall requirement
and developed smart quality management software which offered a centralized platform
to record, monitor and improve quality processes. Among the multiple benefits that we
offered them here are few of the major benefits.

Results after implementing QEdge quality management automation

There was an increase in production due to decrease in resource allocation and management time and a more controlled regulatory environment for quality unit
A centralize platform with effective interlinking of various key process helped in achieving the quality goal with effective investigation and CAPA closure
Facilities like auto-alerts, email and notification helped in waiting time elimination with advantage of real time access to data, trends, reports and pending actions
After the implementation, the physical movement need for chasing and tracking the people was totally eradicated resulted in improvement of production, time saving and better resource management
With the assurance of data integrity and date-time bound e-signature and audit trail, the staff now easily utilize the data that are consistent, reliable and well linked
QEdge quality management automation offered the firm an effective ability to manage, integrate and utilize the data at all stages of the workflow cycle from event initiation to closure which enable it to derive maximum benefits
The last but not the least point is that the ability of QEdge to seamlessly integrate with SAP which provide real-time enterprise-level visibility across diverse sites and functions

Quality Management Automation – Book a Demo Today!

QEdge is a holistic Enterprise Quality Management System that helps automate quality processes. Know more about EQMS here. When it comes to quality processes, a 360-degree approach to managing quality at an enterprise level is very important. Choosing a vendor who can understand your business well and help you experience a seamless digital transformation for quality processes, is a challenge these days. Here are 5 factors that you can consider while choosing the right vendor for your EQMS.