A good DMS helps 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 compliant procedures for information governance. Document control procedures are a crucial requirement of ISO 9001, ISO 13485, ISO 27001, 21 CFR Part 11, and many other standards.

Cognidox has helped many companies automate and formalise document management to achieve their quality goals and streamline their business process. Auditors from certifying authorities have consistently praised Cognidox as among the best document control solution they have seen.

Companies use Cognidox as a place to store information about Audits, Change Control, Corrective & Preventive Actions, Product Quality, Design History Files, Process Mapping, and more.

Workflows

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.

Document review and version control

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 from being created.

Cognidox meets the robust version control and auditing requirements of ISO 13485 and ISO 9001, bringing complete traceability to all your quality decision making.

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

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.

Approvals & FDA compliant e-signatures

Cognidox provides highly 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. ‘Document holders’ within the system allow whole sets of documents to require approval before release, supporting phase-gated development projects.

Users can approve documents using electronic signatures that meet the rigorous authentication standards of FDA CFR 21 part 11. E-signatures are fully integrated into the Cognidox system and do not rely on expensive third-party plug ins.

DocuSign integration

In addition to our integrated e-signatures, Cognidox also provides fully featured 'send to DocuSign' functionality. This is great for contract management or in cases where you do not wish to use the inbuilt Cognidox functionality to sign off documents.

You can configure DocuSign signing envelopes directly in Cognidox providing email addresses for the external signatories required. When you ‘Send to DocuSign’ from Cognidox the signed document will automatically be captured in Cognidox when the process is complete.

Notifications

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.

Forms and templates

Administrators can create HTML forms that can be assigned to categories. Cognidox comes with templates for non-conformance and CAPA forms that you can easily adapt and customise to meet your specific needs.

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.

You can easily create new documents of all types from company-wide or category-specific templates.

Microsoft Office add-in

Use the Microsoft Office add-in to browse, open and save work directly from Outlook, Word, PowerPoint and Excel. Clone or compare Word documents to save time and see differences between documents ‘at a glance’.

This add-in allows users to work with Cognidox directly from their own favourite desktop tools without having to visit the web interface. Great for user adoption and efficient personal workflows.

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 of files, with stats around access and download. Cognidox can also provides comprehensive overview of workers’ acknowledgement of critical policies and procedures via dashboard matrices to help ensure compliance with training requirements.

Security and access control

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. Cognidox helps you meet the rigorous access control and data security requirements of ISO 13485 and ISO 27001.