Achieving rapid yet comprehensive compliance is more important than ever in today’s changing regulatory environment. To move from product development to commercialization, you need tools and solutions that help you simplify compliance and maximize product quality.
The Cockpit platform guides your teams’ compliance efforts throughout product development, making the creation of submission deliverables a fluid part of daily tasks. Leverage Cognition’s regulatory compliance services to name, track, and monitor regulatory requirements throughout product development. Use out-of-the-box templates for industry standards or define your own process templates and standard operating procedures.
Cockpit is key to your Quality Management System Strategy
“Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.” – 21 CFR 820.20
“The manufacturer shall establish, document, and maintain throughout the life-cycle an ongoing process for identifying hazards associated with a medical device, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the controls.”Read More…
– ISO 14971
“…the pharmaceutical industry and regulators can assess and manage risk using recognized management tools and/or internal procedures … Some of these tools [are]: Failure Mode, Effects, and Criticality Analysis (FMECA), Fault Tree Analysis (FTA), Preliminary Hazard Analysis (PHA)…”Read More…
– Q9 Quality Risk Management
“Each manufacturer of any class III or class II device, and [some] class I devices … shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.”Read More…
– 21 CFR 820.30
“Each manufacturer shall establish and maintain procedures to control all required documents… The procedures shall provide for the following: (a) Document approval and distribution… [and] (b) Document changes.”Read More…
– 21 CFR 820.40
What is the impact of a powerful product development platform?
A Cognition-Epic Sciences, Inc. Case Study
SaaS Deployment Saves Time and Money
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Cockpit is also downloadable/available for self-hosting.
Training and configuration services for both SaaS and downloaded/self-hosted instances of Cockpit are available as well.
Cockpit is designed with compliance in mind. Regulatory services and features enable compliance as defined by critical standards relating to medical device and pharmaceutical design. Standards include 21 CFR 820, ISO 14971, and IEC 62366, to name a few.
The Cockpit Platform is hosted on a secure SaaS environment provided by Cognition. Cognition’s SaaS offerings are compliant with SSAE 16 and 21 CFR Part 11. Manage and access your project database in a secure, shared environment made for collaboration.
Cognition offers a guided approach to complying with many standards, including 21 CFR 820.30 and ISO 14971. This method ensures consistent compliance with the regulations and standards throughout all projects; it also produces compliant, submission-ready documents that can be used for regulatory deliverables.
From Market Requirements, to User Needs, to System and Regulatory requirements through to Design Outputs, Cockpit guides teams to manage all aspects of requirements during a project. Requirements can be imported or created within Cockpit, allowing teams to work with them in a central location.
Cockpit provides a full, visual traceability mechanism to see connections from product inception to completion of testing. Our unique linking ability allows teams to easily create connections between objects. These connections are then shown in multiple dashboard views throughout the project.
Out-of-the-box templates for PHA, FMEA, and more. Provided scoring and color matrix options allow you to tailor the Cockpit experience. Risk calculations are done within the platform, reducing the room for error. Cockpit’s built-in risk functions can be configured to suit medical device or pharmaceutical products.