Information flow is evident in the life sciences industry, resulting in more unstructured data. Therefore, quality data is vital for effective and compliant operations as the industry’s regulations are data-driven. So, there are many documents to be managed and controlled with this. Often, people get confused about these terms – Document Control and Document Management. Though the terms are used interchangeably, there is a considerable difference between them.

In this blog, we shall discuss and highlight the differences between document control and document management as they are two distinct aspects and their importance in life sciences organizations.

What is Document Control ?

Document control is the process of maintaining documents enforcing controlled procedures and practices for creation, review and track document editions and accessibility. That is, it refers to the security and credibility aspects. Document control means securing documents, archived, and obsolete necessarily for the long term in a company’s operations. The documents created and gone through a solid approval workflow process are secured for a specific reason. When the organization requires any modification, the documented changes get tracked with time stamps and the user details who initiated the editions. The transformation might give a version increase and get separated from earlier versions or be tracked in the current version’s audit trail.

To keep the document control regulated, access to these documents is limited and outdated versions are archived. For certain users, only the latest versions are accessible. As a result, the controlled documents have a longer shelf life and shorter document life. In addition, the previous versions get updated, and the effective versions are made available to the users for training and use. Therefore, they are less prone to misuse and confidentially with all the comments and editions for compliance and audits.

In an organization, the document control process involves the following:

• Secures the outdated document versions in the form of archival procedure
• Documents aligned in the version history
• The document reviewal and approval workflows are streamlined with e-signatures in compliance with 21 CFR Part 11 compliance.

Document control is vital for all industry types in Life Sciences. With DMS Software, document controlling is seamlessly accessible, keeping track of all documents in the workflow and archived versions with minimum effort also automating the document management process.

What is Document Management?

It might seem that document control plays a vital role with the above information, but that does not mean that document management is less critical in life sciences industries. In simple terms, document management is digitalizing the paper documents, creating them, indexing, validating, editing, and versions updating whenever required and storing them. So, this means that a controlled document is formerly a managed document in the system.

With DMS Software, document management is automatic with configurable workflows and metadata fields. For example, a document created in the system automatically gets indexed with an identification number, timestamp of the created date, and time and creator and owner information. In addition, the workflows are streamlined with e-signatures and non-editable audit logs making it easy to control the documents for inspections and audits. Furthermore, folders segregation, multi-tab view of data input, check-in, check-out functions to work collaboratively on a copy, document change tracking, content downloads, and print option facilitates traceability, search, and easy retrieval process.

Document Control Vs. Document Management – Which is essential for an organization?

Significantly, document management and document control are intricately connected, neither of which the process becomes invalid. Because without document management, there is no aspect of securing it where it means document control. Likewise, the organization lacks security and cannot comply without document control.

Concluding Thoughts

DMS Software is a holistic document management system that streamlines document handling processes like creation, tracking, updating, and securing documents. It is designed with top-notch features and tools required for the organization to manage and control documents in a regulated way effectively. The comprehensive and easy-to-use platform helps small-scale and enterprise-grade organizations to digitalize documents competitively. Regardless of the type and the number of documents, DMS can keep them secured and organized.

Learn more about how DMS functions and has to offer, reach our subject matter expert today at sales@complianceg.com