In the Pharmaceutical and Medical Device industries, document control is an essential quality system element and a regulated requirement because written instructions directly affect processes that impact product quality.
Document control is a major stumbling block for many companies who attempt to manage it manually or with platforms such as Dropbox/Sharepoint that are not developed for GMP-regulated operations. As a Quality professional, you may find yourself spending a significant amount of time routing documents, obtaining approval signatures and organising face to face meetings to discuss any changes made or issues. Manually tracking each activity related to a specific document is close to impossible.
Most companies have different systems for document control, CAPA, audit, training and other Quality related processes, making your life in Quality harder to manage. With disparate systems you have an increased likelihood of miscommunication and tasks assigned from a change in documentation can fall through the cracks.
All important documents related to the development and manufacture of pharmaceuticals or medical devices are subject to regulatory inspections and audits. In manual/hybrid solutions, documents are hard to search for and retrieve. In addition, documents can easily be misplaced. Inadequate document control is a commonly cited GMP deficiency by regulators such as the US FDA, TGA, MHRA, MedSafe and HSA.
To address these challenges, over 1,000 Pharmaceutical and Medical Device companies around the world use MasterControl’s Document Control module, including the US FDA. The Document Management System (DMS) automates the routing, delivery, and approval of documents as well as delegation where required. Version history automatically evolves with each document and it can handle all types of documents regardless of the software used to create them. MasterControl features a centralised, secure repository that makes search and retrieval easy.
Document changes can be initiated by an individual, automatically based on the defined review cycle or even from events in other MasterControl modules, like CAPA and Change Management. With a single source of truth, MasterControl’s DMS will allow you to launch and track Training requirements created by a change in documentation. Learn more about how Document Control and Training Management modules are integrated as a Learning Management System (LMS) here >> Learning Management System (LMS) for Pharmaceuticals & Medical Devices
SeerPharma is a strategic partner of MasterControl and has deployed this document control solution for many companies in the Asia-Pacific region.
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