Document Control System
Document control in the pharmaceutical industry is in an integral part of the good manufacturing practice that regulates the pharmaceutical industry and has evolved from manual document control to the electronic document control that is currently being used documentation of the drug manufacturing process ensures quality control and that the drugs being manufactured meet laid out regulations of the industry as it is required that all quality control and procedures be put in writing.
Over the years, the methods of controlling documents have evolved from the days of storing documents in boxes and files that took up huge amounts of space in pharmaceutical companies to the dawn of imaging systems which allowed for companies to scan documents and have an electronic record. This was a major milestone back then but was too rigid as it limited the use of the scanned information which led to pharmaceutical companies investing heavily in the development of Document Management Systems (DMS).
Document Management Systems enabled the pharmaceutical companies to encompass documentation of the entire manufacturing process from reports to quality control. This enabled an electronic record of the entire drug manufacture process which aided in the faster testing and approval of drugs. DMS’s also enabled consolidation of individual submissions of everyone involved in the manufacturing process. Other benefits of using document management systems included automation of processes such as archiving, document revision but to name a few.
There are a number of pharmaceutical documents management systems out there though the majority of the pharmaceutical companies have their systems custom built to suit their practices and procedures. As with many industries in the world today, security is a major concern and for pharmaceutical companies, nothing matters more than the security of their drug documentation.
Major drug breakthroughs make pharmaceutical companies billions and having a document management system controls the flow of information with various levels of security being able to be set within the systems Another major control that pharmaceutical document management systems are able to provide is a communication breakdown. During the olden days of paper processes, it was quite easy for documents to get lost while moving from department to department or even get overlooked by people who were meant to look at them as the sheer amount of information passing on any given day was difficult to manage and process.
Document Management Systems enabled for the automation of this and for all data relating to a particular project being consolidated in one place ensuring greater quality and efficiency in the manufacturing process. Document Management Systems don’t work in isolation however as they can be integrated with other systems to help streamline the manufacturing process even further. Such systems include and are not limited to; publishing systems, enterprise compliance management systems but to name of a few.
Document control in the pharmaceutical industry remains the most important part of the drug development process and technology has enabled the industry to manage data better through the innovation that continues in the development of these systems. Document Management Systems remain provides the most viable way of controlling and managing documents within the pharmaceutical industry.
