QMS : The Protective Shield of Document Management System

In any pharmaceutical industry, DMS (Document Management system) is the backbone of the whole system. 

During the regulatory inspection first thing comes in scrutiny of inspectors is DMS.

Starting from the Company policies to recording system of formats is well arranged in Pyramid manner. 

Want to know about the Pyramid of Document management system? Understand the Pyramid of Document Management System (DMS) 

But....

How to maintain the Pyramid of DMS?

This is the most important thing to know...

In parallel to the Document system management, one very wonderful system is also evolved.

This system is known as QMS(Quality Management system).

The main role of QMS is to protect DMS.

Nexus of DMS and QMS


With writing of documents to run the manufacturing process to analyze the drug to sell the drug in market and finally to consume the medicine, In these whole cycle human is involved. 

Where human interventions are there, chances of making errors are always there.

In addition to that to cope with the regulatory requirement and to sustain the product quality at every stage of manufacturing is very critical in this competitive environment. 

In this situation how to maintain/protect the DMS pyramid?

Here various QMS elements plays critical role to protect the DMS pyramid. 

First weapon of QMS is "Deviation" which is known as an error acknowledgement tool. 

Second weapon of QMS is "Change Control" which is known as a change establishment tool. 

Third weapon of QMS is "Corrective action and Preventive action" which is known as an error controlling tool.

Forth weapon of QMS is "Complaint" which is known as a Customer care taking tool.

Fifth weapon of QMS is "Risk management" which is known as a Pre diagnosis tool.

Sixth weapon of QMS is "Self-inspection" which is known as a Health checking tool.

Seventh and most important weapon of QMS is "Training" which is known as an Empowerment tool.

In addition to that other predetermined weapons are also there to protect Document management system such as Specification, Validation and Qualification systems.

These all weapons jointly make the protective shield around the DMS Pyramid.

Please note that regulatory guidance is already available for the Quality management system, but to understand the term and its ideology, this is small try.



Location: Ahmedabad, Gujarat, India

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