What is document control and why do companies need a document control tool? Control of documents is most relevant to companies that are regulated, such as pharmaceutical, medical device and other life science organizations, as well as companies that adhere to quality standards, such as manufacturing, high-tech, and oil and gas companies.
In this day and age of digital information, documents are increasingly generated and stored electronically. Accordingly, document control tools available in the market today are electronic and/or web based.
Sélectionnez toutes les ressources que vous souhaitez télécharger.
In regulated environments, maintaining a state of control in quality processes is paramount. It could make a difference between a safe product and a defective product. Companies realize that a document control tool can help them navigate the complexities of the process.
The need to control quality documents and the motivation for companies to utilize a document control tool stem from regulations such as such as 21 CFR 211.100 for pharmaceutical companies (pertaining to written procedures and deviations) and 21 CFR Part 820 Subpart M for medical device companies (written records). International standards such as ISO 9001:2008 for general manufacturers and ISO 13485 for medical device manufacturers also require the development of a quality management process and the appropriate documentation of the process.
In evaluating document control tools, companies should keep in mind what document control entails: reviewing, changing/updating, and approving documents in a way that shows the reason for the change, who approved the change, and when. It also entails controlling revisions and making sure that users have the latest approved version. For FDA-regulated companies, they should make sure that the tool they choose have electronic signature capability that complies with 21 CFR Part 11.
While document control is necessary for compliance, a document control tool also helps companies improve efficiency and increase productivity. Companies that rely on paper-based or partially electronic systems typically experience the following challenges:
MasterControl quality and compliance software is designed to address requirements in highly regulated environments such as the life science and manufacturing industries. It is more than just a document control tool; it is a complete solution that can serve as a foundation for all quality processes that make up a quality management system. It offers the following benefits:
For additional details about the document control tools from MasterControl, please feel free to contact a MasterControl representative.