Document Control System: The Core of Quality Management System

Has managing documents always been a tedious and time consuming task for you?

Have you faced issues of cost drain and compliance while maintaining the documents for medical devices? We understand! read below to learn about some document control systems that can help make almost any business more efficient.

Due to the very nature of the regulations and requirements for the medical device industry, and a plethora of documents that are generated when developing, marketing or maintaining a medical device; a Document Control System (DCS) which would facilitate the creation, review, modification, and access of the documents throughout their lifecycle is very much required.

Implement DCS for following:

Everyone sooner or later concurs that Document Control is something important; the question is should the DCS be an electronic system or paper?

Someone rightly said:

“It is very hard to transform your culture and your workforce to be a relevant company in the digital world if all of your processes are stuck in the traditional world.”

Quote Credit: Brainy Quote

Since everything today is getting digitized, with its obvious advantages, you can choose from some very good Electronic Document Control Systems (DCSs). Even though e-DCS is not a new concept and has been there for a while, but companies are now, more than ever, moving towards cloud-based DCS which can be accessed almost from anywhere across the world.

The key milestones of a typical e-DCS workflow includes creation, review, approval, release, and storage.

e-DCS workflow

Some Great Tools For Implementing Efficient Document Control System (DCS)

Here is  a quick summary of some useful features of common e-DCS:

Almost all of these solutions are primarily for document review, approval and storage and don’t offer other features such as CAD systems tools for analysis, simulation or visualization.

In Spite of the various useful attributes that each of these platforms offer there are some limitations like inability of allowing effective multi-user collaboration for comment, review and approval on the same document without uploading and routing it again for approval and release.

Some users report certain DCS to be not very user-friendly and not providing access to features that enable customized searches; whereas some report that Document Control System (DCS) does not provide them Bill Of Materials (BOM) feature to add subassembly of a device.

But, no system is perfect, and it is important to identify and deploy a system that would most effectively address your requirements.

With all the excellent tools that we can get our hands at today, the importance of human intervention is not undermined, but, it is now all the more important to have a competent, well trained, sincere and honest Document Controller to take charge of the e-DCS.

Elexes has provided dedicated DCS assistance with a strong emphasis on compliance and traceability for small and medium sized companies. 

Effective Document Control System (DCS) is essential to revolutionize modern medical device businesses. Revisit your document control system today and make the right choice.

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