Bio Pharma Briefings

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 all Pharmaceuticals and B iopharmaceuticals industries, documents play an important role.  A very practical saying says that, "IF IT IS NOT DOCUMENTED, IT WAS NOT DONE" But, how documents come into existence and what is flow of documents in the industry. The hierarchy of documentation makes a lot of sense and it is interesting. Level of Documentation system One must understand that, Any organization or industry starts with the some motive and vision/objective. This one line note which is known as "Visionary Note" or "Objective line" .   This one-line message is very directive as it provides the general idea to the people of the foundation.     "Visionary Note" is owned by the Founder or the chairperson of the Organization. Based on the Visionary Note, Board of Members writes the "Policy" . What is Policy? A policy is a deliberate system of principles to guide decisions and achieve rational outcomes. It is also known as "Concept...