The Nemedio Blog:  Demystifying Compliance

your guide to product development and compliance for medical technology

Principles of document control

May 5, 2022

Broadly, document control is the concept of ensuring that your organization's documents are correct and that changes to documents are processed through a well-understood system. For today's organizations, documents are more than just pieces of paper (that's why on the Nemedio system, we refer to them as "items"). Document control is required as part of the Quality System Regulations, and is described in 21 CFR 820.40

When an engineer creates new designs, the first thing they do is to document these changes on a report in the system. Doesn’t sound familiar? Well that seldom happens, and a management agreed structure is the only way to make sure this happens in a regulated company. Document control allows for each person in the organization to have access to the correct version of each document whenever it is needed. This way, the entire team is aligned and errors due to mis-matched documents are eliminated. An important concept in document control is change management. All changes to documents under document control must be managed according to a specified process that includes a description of the change, signature of approval, and effective date of change.

Design controls specify types of documents that are required to be generated as part of the design and development process. These documents are required to be produced under document control in order to manage changes to any design documents. Design documents required include items like design inputs, design outputs, design reviews, and design changes. These documents are all stored in the Design History File (DHF). The DHF is a record of the design activities of the device that show it was designed under proper document control and according to applicable regulations.


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