Standard Operating Procedure (SOP)
A standard operating procedure (SOP) is a company’s documented method for its business processes. An SOP typically emphasizes the legal and regulatory issues associated with the process.
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Why Do You Need an SOP?
A company’s efficiency is dependent upon there being a single source of truth for how to perform tasks. Not only does this make sure that everyone’s on the same page, it’s also essential for surviving an audit. Of course, SOPs are only as good as the system used to create and manage them.
How Can a Document Control System Improve Your SOPs?
- More Efficient: Using an automated system gives you a centralized and secure repository for all your SOPs, making search and retrieval easier. This is especially important during inspections and audits when you need to gather all your current SOPs on demand.
- Document Revision Control: Since businesses are always changing, the SOPs of a business need to change as well. This presents one of the biggest challenges in SOP management – keeping track of those changes. An automated system can track, not only the changes, but also who made them and why.
- Integrated Training: Once SOPs have been updated, it’s important to make sure all personnel are trained on the new procedures. Some document control systems can be integrated with training systems to ensure that modified SOPs trigger a training request. Management can then monitor which employees have completed the training.
- Increased Management Visibility: Along with seeing who has completed training and when, an advanced document control system with analytics capabilities can create customizable reports with charts and images. This allows managers to view information specific to their needs.
Electronic Standard Operating Procedure (eSOP) Benefits
As with most business processes, things dramatically improve when you move from paper to electronic. An electronic SOP offers many improvements over its paper-based predecessor. The SOPs can all be kept in a centralized location and accessed from anywhere. A digital SOP can also keep track of revisions and make sure the most current SOP is the only one available to employees.
Core Capabilities of an SOP Management Tool
To optimize electronic SOPs, businesses need to invest in an SOP management tool. These tools provide the following benefits:
- Combine powerful electronic routing and approval.
- Provide a full audit trail and reporting.
- Include electronic signature management and control.
- Ensure 21 CFR Part 11 compliance, as well as security and integrity of documents.
Stay Compliant With MasterControl
It is possible to move away from outdated, disconnected, and inefficient SOP management practices. Electronic SOP software solutions are part of MasterControl’s content management suite. The suite includes easy-to-use, fully integrated applications that can be configured to meet the unique needs of small, mid-sized, and large companies. These solutions help companies establish compliant SOP management systems so they are always ready for inspections and audits.
MasterControl and the FDA
Organizations all over the world use MasterControl software solutions to ensure compliance – including organizations that enforce compliance. The U.S. Food and Drug Administration (FDA) became a MasterControl customer in 2009. Since then, the FDA has expanded its use and now multiple divisions of the agency use MasterControl software solutions.
The QMS Provider for the FDA
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.
Need more information?
To learn more about MasterControl's software systems, please contact a MasterControl representative.
