Document Management System (DMS) Support

A QMS is a DMS specifically intended for storing and maintaining quality documents, such as SOPs (Standard Operating Procedures) and WIs (Work Instructions). We are experienced in authoring SOPs/WIs and setting up your complete QMS.

Using a DMS has many advantages and is almost essential for companies involved in regulatory affairs. The following functionalities for DMSs are most useful for managing regulatory documents and files:

Version Control:

this ensures a compliant way of working with saved document histories and data loss is prevented. Changes are tracked and time stamped (referred to as an ‘audit trail’ necessary for compliance). Users also can access the most recent version of the document.

Collaboration:

a DMS allows users to exchange and collaborate on documents. Some systems have functionality for branching and merging, allowing users to work on different versions of a file simultaneously and later combine their changes. Other systems use a check-out/check-in process, by which only 1 user can work on a document at a certain moment by checking it out. This provides transparency for users on the status of the document and ensures users will not overwrite each other’s versions. 

Review and Approval:

as a quality assurance process, second person review is key to ensure accuracy, completeness, and compliance with regulatory guidelines. A DMS typically facilitates automated and documented reviews and approvals by functionalities such as workflows and tasks.

Document Properties or Metadata:

metadata refers to structured information that describes various aspects of documents. Such information can be registered in a DMS as the ‘properties’ of a document. Examples of metadata are title, author, creation data, document type, regulatory region, or keywords. The metadata helps with the identification of documents and provides context to determine relationships between documents. In addition, registration of properties for a document allows users to perform advanced searches in a DMS to quickly locate specific documents or sets of documents. 

Security:

for medicinal product and medical device developers and manufacturers, securing their information and intellectual property is extremely important. A DMS should have extensive security settings. Such functionalities typically exist in the form of access permissions and restrictions for each user. 

Accessibility:

many DMSs are cloud-based, which enables users to access files from anywhere. Whether you are at a conference, in a lab or home-based, this accessibility is more practical than storing files locally.