Cockpit Enterprise

MAINTAIN A SINGLE SOURCE OF TRUTH WITH STRUCTURED DATA FOR YOUR MEDICAL DEVICE PRODUCT DEVELOPMENT

Cockpit Enterprise is our software application for medium to large medical device product development teams that integrates requirements management, test management, risk management data, and more, in a unified environment. Cockpit Enterprise is highly configurable and can be personalized to meet a company’s needs. It has a rich development framework that allows organizations to implement their Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a controlled and auditable environment. Ultimately, Cockpit Enterprise helps medical device manufacturers of Class II and Class III devices author, review, and approve the documents required for regulatory submissions and audits.

Cockpit Enterprise is best suited for mature organizations that have established standard operating procedures and can dedicate the necessary resources to configuring and deploying the system.

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Core capabilities

Key features

Cockpit Enterprise has many individual features that support product development teams in their endeavor to develop safe and effective products. This list below represents the most valued features as reported by Cognition’s customers.

TRACEABILITY

Fundamental to Cockpit Enterprise, traceability is accomplished through a controlled process that enables your organization’s standard operating procedures to be executed. This ensures the integrity of the linkages being made between items, and unlocks the ability to do meaningful impact analysis and automated report generation. Trace matrices are created as data items are linked and enable constant monitoring of the project status and whether all inputs are met by appropriate outputs and the project status overall.

DESIGN CHANGE IMPACT ANALYSIS

With fully traced data items, impact analysis becomes second nature. The effect of changes on upstream and downstream data connections can be easily viewed before making a change. Cockpit Enterprise enables you to view traceability from a system level, such as a trace matrix between all design inputs, design outputs, and test procedures. Or you can zoom in to a single data item such as a system requirement and see everything that it is connected to, including upstream user inputs, downstream subsystem requirements, risk controls, and verification tests being performed.

HISTORY TRACKING

Every data-entry activity in Cockpit Enterprise is recorded and timestamped to create a fully auditable log of change history. See who made the changes, what they changed, and when they made them.

ASSET LIBRARIES

Cockpit Enterprise allows for the creation of controlled, preapproved asset libraries, such as a harms library with defined severity scores. Asset libraries can be connected to multiple projects so that the same database is used. This eliminates errors due to recreation or mis-alignment across projects.

CUSTOM DOCUMENT TEMPLATES

In Cockpit Enterprise, creating custom, reusable document templates that match your standard operating procedures and requirements for notified bodies is standard functionality. Document templates save an enormous amount of time by providing a structured framework in which to work and are configured to automatically pull in data from the project as it is being created. All document content is updated automatically as any data in Cockpit Enterprise is updated. There is no need for any manual updates to get the desired outcome.

DOCUMENT REVIEWS

Document reviews can be performed right in the system to avoid long cycles of exporting, reviewing, and requesting changes. In Cockpit Enterprise’s document review feature you can suggest changes, review the change, approve it, and implement it all prior to exporting the document to the document control system. Individual items (requirements, risks, and tests) can also be reviewed in the system with the same functionality as document reviews.

CUSTOM REPORT GENERATION

Similar to impact analysis, project reports can be generated to show a wide range of critical information. Reports can show information about data items, such as all requirements that do not have a defined target value. Additionally, reports can show information about relationships, for example, all requirements that do not have a test protocol linked to them. Dashboards can be created to visually show status as a visual snapshot, instantly-up-to-date with no manual tracking necessary.

DOCUMENT EXPORTS

Exporting documents is straightforward and fast in Cockpit Enterprise. Export in either Word or PDF, and include a cover page, headers, footers, and watermarks as required. Documents export submission-ready with no post-processing required.

CHANGE REQUESTS

Cockpit Enterprise has strong change review capabilities that allow you to propose changes, analyze their impact, review, and approve them prior to implementation. When you are ready to make the changes official, you can implement them confidently with one click.

SEARCH

Cockpit Enterprise has a rich search feature that enables you to quickly find items across the entire ecosystem, which may include many individual projects. Search within specific data types, within specific attribute fields, or search universally for a word or phrase. Cockpit Enterprise doesn’t just find words on the screen, it can return the individual data objects that you are searching for.

WHAT OUR CUSTOMERS ARE SAYING ABOUT COCKPIT ENTERPRISE

With Cockpit Enterprise we manage our data, create our documents, review and approve them, then export them to our official system of record. For us, Cockpit Enterprise is an automated DHF document authoring tool.“

– Implantable Medical Device Company

I can’t say enough good things about the team and the attention we get. The people at Cognition want us to do well and are extremely responsive to us. Cognition is an excellent software vendor partner.“

– Medical Instrumentation Supply Company

Our Systems Engineering team owns the product development process and is at the center of it, but, by using Cockpit Enterprise we have allowed other groups to gain access to the electronic environment and make their contributions independently. For example, our Marketing team was able to log in and write their own user needs.“

– Medical Diagnostics Company

What has given us success is our ability to create and develop templates that precisely meet, requirement-for-requirement, our quality system – that’s huge! We have configured Cockpit Enterprise based on the foundation of our global quality system, and our templates have been validated to meet our global work instructions.“

– Minimally Invasive Medical Device Company

I have seen other tools that create a spreadsheet-like risk table in an attempt to check the box for risk management, but in my experience those risk capabilities are not data driven like in Cockpit Enterprise. A huge differentiator for Cockpit Enterprise is the ability to manage the Risk Chain.“

– Orthopedic Medical Device Company

Before we had Cockpit Enterprise, the problem we faced was that when I went to update document A, I really needed to update document B as well. So, you end up with a change process which attempts to get people to do this manually. In Cockpit Enterprise I no longer have to do that, changing document A automatically changes document B. In the old way the changes may never show up, which would end up in a potential CAPA situation.“

– Interventional Medical Device Company

WHY DO LEADING COMPANIES CHOOSE COCKPIT ENTERPRISE?

Enterprise Level Configurability – results in a robust system that allows for maximum efficiency and accuracy when developing new products.
Data Integrity – provides a “single-source of truth” for every data item – if a requirement is changed in the product requirements document for example, it is automatically updated throughout.
Industry Leading Risk Management – break free from the confines of isolated, 2-dimensional spreadsheets for a risk-first approach that places high emphasis on the value of tightly integrating risk management in the design control process with requirements and tests.
Cross-Functional Integration – collaborate effectively and develop in unison, with a full view of the entire development environment.
Dynamic Document Authoring that is Submission Ready – combines database style functionality with document authoring, reviewing, and approving.
Open Platform for Integration – easy to use REST API and off the shelf integrations with outside tools such as Jira, Sparx Enterprise Architect, and Microsoft DevOps.

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