Using a Document Control Tool for Compliance
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.
Using a Document Control Tool for Efficiency
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:
- Longer Turnaround: Routing documents manually or sending it by e-mail and sending documents back and forth the same way usually means longer turnaround time for document approval. There is also the risk of misplacing documents. An electronic document control tool can easily remedy the situation and speed up the turnaround time.
- Disconnected Processes: Paper-based and hybrid processes cannot be easily integrated. When processes are not connected, communication may break down or important issues may fall through the cracks. When looking at document control tools, companies should keep connectivity and integration in mind.
- Lack of Transparency: If information and documents are stored in different places (filing cabinets, electronic spreadsheets, database, etc.), quality processes are not as visible to managers, as well as regulatory inspectors. An electronic tool greatly increases transparency and inspection readiness.
MasterControl is More than just a Document Control Tool
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:
- Automation and Standardization: A primary advantage of using an electronic document control tool is standardization of documents and processes, making t easier to review during inspection. MasterControl automates distribution, review, follow-up, escalation, and approval of documents. It makes search and retrieval of documents faster and easier.
- Connectivity: Unlike other document control tools, MasterControl can integrate all quality processes for a seamless approach to compliance. For example, by integrating the document control process with the training control process, any substantial revision to an important SOP could invoke training to affected users upon approval of the SOP revision.
- Centralized Platform: MasterControl provides a single location for all quality documents and records. MasterControl is web-based so authorized users have access to the system from virtually anywhere 24/7.
- Accountability and Transparency: MasterControl increases individual accountability because every user's action in the system is documented and it can be tracked. The system's robust analytics and reporting capability increases transparency by providing either standard or customized reports that help managers evaluate quality processes.
- Increased Efficiency: One of the biggest advantages of using electronic document control tools is increased efficiency. MasterControl automates and streamlines quality processes and workflows, helping save time and effort and greatly boosting productivity.
For More Information on Document Control Tool
For additional details about the document control tools from MasterControl, please feel free to contact a MasterControl representative.