QMS & DMS
Ramzi Shaheen
Computer Systems Validation Lead / Senior Validation Engineer cGMP | GAMP | ISPE | PIC/S | USP | US FDA
What Is QMS?
Organizations that use a Quality Management System aim to conform to certain specifications, standards, and customer expectations efficiently. All of your organization’s resources, processes, policies, procedures, internal controls, people, and goals are focused on producing the desired output.
What Is DMS?
Document management software is a system to produce, track, organize, and manage paper or electronic documents. Modern document management software helps companies safely store important documents while restricting access to authorized users. Document management software can help your organization move seamlessly to a paperless office.
Overlap of DMS and QMS
Both QMS and DMS require the storage of important information and rendering it accessible to authorized users. Relevant documentation and records must be found quickly to help your organization act and react. QMS may require people to follow a workflow structure similar to DMS. This means that employees must follow a set of tasks to perform their job according to a specified workflow.
Both DMS and QMS rely on the use of audit trails. To maintain the integrity of your document, it’s important to audit the electronic paper trail. Fortunately, modern DMS makes it easy to see when a document has been altered and who was able to access it. Your DMS can also show you previous versions of the same document.
QMS uses audits to ensure that the products are of the desired quality. Audits may be performed for each of the different production stages, including but not limited to document creation.
Strengths of Quality Management Systems
What makes a quality management system so important? The biggest advantage of using a QMS to ensure product quality is that all of the steps in the production, service, and operations processes are covered. A QMS doesn’t merely concern itself with eliminating ineffective procedures; instead, it can also do the following:
- Document all specific requirements
- Confirm that employees undergo applicable training
- Create performance processes and align them with the quality system requirements
- Measure and monitor compliance
- Audit current processes
- Include processes to improve the quality system
Strengths of Document Management Software
What are the advantages of using effective DMS? The biggest is that your organization can guarantee the availability and authenticity of its documents. Your DMS doesn’t merely concern itself with storing your documents safely; it also allows administrators to:
- Create and control access to documents based on user authorization
- Make information available to users in different locations.
- Design and implement a workflow for document creation
- Automate processes for archiving and deleting documents
- Provide the ability to search documents quickly and easily
- Allow authorized users to follow the audit trail.
The Possibilities of Merging DMS with QMS
It’s easy to see that both DMS and QMS are important to your organization. They are certainly not mutually exclusive. In fact, your organization can benefit from combining the use of QMS and DMS. To ensure the creation of quality products, your organization needs to produce, save, and manage associated documentation.
Document management software like eFileCabinet can be used to store your quality control procedures. User-based access ensures that the right employees have access to relevant documentation. Merging, the two systems might make it easier for your company to ensure quality.\
Saving Documents Inside of Your QMS
Merging your quality management system with your document management software would enable you to save important documents inside your QMS. In fact, your employees wouldn’t need to leave the QMS program to create, add, edit, or archive important documentation for each of your quality assurance processes.
Setting Up Unique Users
Merging QMS with DMS would eliminate the need for separate logins. Unique user access can still be granted based on different user roles. Of course, it’s important to clarify your employees’ responsibilities to ensure that they have the tools they need to do their job in the combined system.
Using QMS and DMS Together
It’s quite likely that QMS and DMS will merge in the future to help your organization produce high-quality products while keeping all required documentation safe and secure. There is certainly a need for both QMS and DMS in many different industries.
Until QMS and DMS merge, it’s necessary to use both in combination with each other. Fortunately, it’s easy to save, organize, and share your documents with eFileCabinet, whether they are related to your quality management system or not.