Document Management System

Enterprise-grade document management

A good DMS can help high tech and medical device developers manage their information, control their operations, and consistently deliver value to the market.

The core document management features of the Cognidox Lean DMS:

Document control for high tech and med dev products

Cognidox supports standards-compliant procedures for information governance. Document control procedures are a crucial requirement of ISO 9001, ISO 13485, ISO 27001, 21 CFR Part 11, and most other quality certification standards. You don’t need an electronic document management system to comply, but having one makes it far easier to achieve compliance.

Cognidox has helped many companies in this task. Its deployment has elicited comments from external Auditors that it is the best document control solution they have ever seen. Companies use it as a place to store information about Audits, Change Control, Corrective & Preventive Actions, Product Quality, Design History Files, Process Mapping, and more.


Business process documents can be routed to users for their action, for instance, for review or for approval, etc.  Set up flexible routing rules based on type of request, document type and security profile.

EM124 Document Management graphics V2-02-1


With the Cognidox Lean DMS there are multiple ways to review documents. As well as shared notes, you can provide comments on the document review page and you can upload new files such as tracked changes word documents.

Other review types such as formal review meetings and external feedback are available. It is also possible to check out a document while the reviews are coming in to prevent a new draft being created.

EM124 Document Management graphics V2-04 (1)-1

Shared notes

This function allows teams to add notes to a .pdf of a document. Notes are initially private but once shared they are available to all other reviewers of the document and are saved in the document review history. This allows a document owner to see all reviews in one place.

Authors often need to work on the new document version offline. To help an author with this, Cognidox allows notes to be exported to a spreadsheet that includes the document pages.


Cognidox provides extremely flexible approval rules. Users can set up approvers based on categories, document types, or just individual documents. Single or multiple approvers can be established from a pre-defined group.


Every draft and approved version of a document is held in the system along with every review comment and approval history.

EM124 Document Management graphics V2-01 (1)

Digitally signed PDFs

As an additional step following approval, users can create a digital signature on an issue of a document. A digital signature requires a user to enter a personal signature password and will create a unique digital signature file for the issue of the document. The signature file can be used to confirm a user has signed a particular issue of a document. Cognidox offers CFR 21 Part 11 compliant digitally signed .pdfs.


You can create flexible, user-based notification filters. Automated email reminders can be set up to alert user when document reviews are overdue, provide weekly reminders of outstanding tasks, and more.

EM124 Document Management graphics V2-03 (1)


Administrators can create HTML forms that can be assigned to categories.

Forms can consist of any number of administrator-defined fields and rights to create a form can be defined. Users filling in a form will create a new document in the form category.


Create new documents from company-wide or category-specific templates.

Pre-filtering of Office files

Pre-filtering of MS Office files will change both the document properties and the values embedded in the visible document, without requiring a macro or update to change the fields. Mark your document Draft, Approved, include the document part number, etc.

Enterprise search

Our lean DMS offers an enterprise search platform for relevance-based full-text search. Users can also search by meta-data and document attributes - perfect for document locate-ability.

Document analytics

Track internal usage or set up a goal for a particular document you want people to view.


Security profiles applied to document sets or to categories provide very fine-grained control over who can see documents, and what further rights they have to change them.

Document management document control medical devices


Related post: