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Holding the expertise of more than 3 decades our client is one of the leading global pharmaceutical formulation development, manufacturing and marketing company, headquartered in India. Besides very strong presence in domestic market it is also present in more than 70 countries worldwide like USA, Europe, Australia, Africa,
Asia-Pacific and many more. It’s approved by many regulatory bodies across the world like USFDA (USA), MHRA (UK), TGA (Australia), CDSCO (India), EMEA (European Union) involved in a range of products including tablets, injectable, capsules and many more. To grow multiple folds, they understood the need of quality management automation.
Pharmaceuticals, Healthcare and Life Science are few of the industries bound to comply with globally acclaimed quality standards to survive in this highly competitive business world and for that they need to follow rigorous internal audits to comply with the set standard operating procedures.
Initially our client was using Microsoft tools like word, spreadsheets to record, monitor and analyze quality data but that was not effective and failed to respond various complexities like:
QEdge – DMS module offer SOP management, controlled copy release and many more within a single platform. SOP’s, annexures and other relevant documents are used in regulated environment to ensure completion and control of various critical processes and procedures. A regulated environment and various associated department use various documents and SOP for performing important tasks and hence such documents play a crucial factors during inspection and audits by regulatory agencies.
QEdge- DMS module help to track and manage organizations’ SOP’s and other relevant documents in the most effective way by providing an efficient tool for SOP management and controlled copy release. The salient features of our document management system includes:
As a result we developed a dynamic, configurable quality management software with a centralized platform to manage, report all its quality processes, track the status in real time and identify and analyze issues and trends as they arose. Among the many benefits here are few of the game changer benefits in the below:
Within few days of QEdge implementation for CRF, Deviations, Investigation, CAPA and risk assessment;