Document Control Application and Regulatory Requirements
Regulations enforced by the U.S. Food and Drug Administration (FDA) are perhaps the most widely known in the world because most companies want to sell their products in the United States-the world's single biggest market. Document control is an essential component of FDA regulations such as 21 CFR 211 (for pharmaceutical companies) and 21 CFR 820 (medical device). Most document control applications in the market today address FDA requirements.
Many regulated companies outside of the FDA jurisdiction adhere to international standards such as ISO 9001 and ISO 14000, which also require document control. In Europe, many regulated companies must comply with regulations such as MHRA and EMA and guidelines such as EU Annex 11, ICH, and EU GMP, which all have similar basic requirements about documentation and recordkeeping. A document control application can be very useful to companies that comply with these regulations and standards.
Document Control Application versus Paper-Based Process
Even in this day and age of digital information, a document control application may be unheard of in many regulated companies because the majority of them still use paper-based processes. While these traditional processes may be sufficient for small companies, they are usually inadequate and inefficient for bigger companies, especially those looking to compete globally.
Here are some common problems encountered by companies using manual processes that could be easily addressed by a document control application:
- Inefficiency: It is not uncommon for companies using manual processes to hire an entire team to handle document management exclusively. The team would be responsible for manually distributing, tracking, and collecting documents, and then sorting through all revisions and changes, and collating them in binders. The process is not only labor-intensive but inherently inefficient - both of which can be remedied by most document control applications available today.
- Lack of Connectivity: Even with an entire team devoted full-time to document management, a paper-based process does not connect the team to other quality processes. For example, when an essential manufacturing SOP is substantially changed, someone in the quality team would have to initiate the training of all affected employees. When there are dozens of such SOPs being changed all at once, training may be lag behind. A robust document control application will be able to integrate training with the document management process.
- Lack of Visibility: With a paper-based document management process, a quality manager will not be able to readily see where bottlenecks are or identify issues that need to be escalated. When an auditor or inspector comes, it is not as easy to show processes or search for documents. This lack of visibility is something that a document control application could easily remedy.
Benefits of MasterControl Document Control Application
MasterControl quality and compliance software is widely used in highly regulated environments such as the life science and manufacturing industries. Its document control application can serve as the centerpiece of a quality management system, supporting all other document - or forms-based processes such as CAPA, change control, training control, and audit management, among others. Here are some of the benefits of using MasterControl:
- Automation and Standardization: The MasterControl document control application will standardize all documents-based processes and automate distribution/routing, review, follow-up, escalation, and approval of documents. It makes search and retrieval of documents faster and easier.
- Increased Efficiency: Switching from a manual process to an electronic document control application will help save time and effort in performing routine tasks. With MasterControl, users can significantly cut the turnaround time for many documents - and forms-based processes, improving individual productivity. Connectivity: Unlike other document control applications, MasterControl can consolidate document control with other quality processes such as training control, audit management, CAPA, and change control, among others. This integration and consolidation will help ensure that quality and other issues will not fall through the cracks.
- Centralized Platform: MasterControl is more than just a document control application, it also serves as a centralized platform for all quality documents and records. MasterControl is web-based so authorized users have access to the system from virtually anywhere 24/7.
- Mobile Access: A distinct advantage of MasterControl document control application over other document control applications is that it allows a user to access documents, tasks, and processes via a tablet or a smartphone. This capability can be very helpful to executives who travel often but are required to review and approve documents, as well as other field-based staff or remote staff. Mobile access means those users will be able to participate in documents - and forms-based processes quickly and conveniently.
For More Information on Document Control Applications
For additional details about the Document Control Application from MasterControl, please feel free to contact a MasterControl representative.