Guided Approach White Papers

Cognition’s latest product, Compass, provides a simple, guided approach to compliance for medical device, pharmaceutical, and combination product industries. Download our latest white papers on our Guided Approach today to learn more about how Cognition and Compass can help you!

Design Controls Template

The Cognition Design Controls Template runs on Cognition's powerful Cockpit Platform. Using this template, teams are guided through the process of Design Controls as defined by FDA in 21 CFR 820.30.

Preliminary Hazard Analysis Template

The Cognition PHA Template runs on Cognition's powerful Cockpit Platform. Using this template, teams are guided through the process of completing a PHA exercise as outlined in commonly followed standards.

Design Controls Series White Papers

Dive into this series of white papers written by Michelle Lott, founder of Lean RAQA, and Scott Wright, CEO and founder of A Wright Path, as they explore design defects and deficiencies as relating to the various sub-parts of 21 CFR 820.30. Each paper in the series outlines the breakdown of 483s issued by FDA for each given sub-part of the regulation.

Part 1: Risk Control and Usability

Risk Management and Usability are key factors to the success of product design, making them a focus point in the Design Controls discussion. Part 1 is a systematic review of 483 data and common breakdowns in 21 CFR 820.30 (c) and (d).

Part 2: Design Controls

Part 2 in the series analyzes 483 citations and design control trends. This paper focuses specifically on trends related to the first two elements of a robust design control system: procedures and planning.

Part 3: Design Input and Design Output

The third paper in the series conducts a systematic review of Form 483s issued by FDA in 2012 and 2013 and common breakdowns in 21 CFR 820.30(c) and 21 CFR 820.30(d).

Part 4: Design Review

The third paper in the series conducts a systematic review of conducts a systematic review of 483 data and common breakdowns in 21 CFR 820.30(e).

Part 5: Verification and Validation

The third paper in the series conducts a systematic review of Form 483s issued by FDA in 2012 and 2013 and common breakdowns in 21 CFR 820.30(f) and (g).

Part 6: Design Transfer

The third paper in the series conducts a systematic review of conducts a systematic review of 483 data and common breakdowns in 21 CFR 820.30(h).

Part 7: Design Change

The third paper in the series conducts a systematic review of Form 483s issued by FDA in 2012 and 2013 and common breakdowns in 21 CFR 820.30(i) and (j).

Cognition Cockpit White Papers

Validation Kit

Download the Cognition Cockpit Validation Kit to learn the importance of running in a validated environment. Also learn how the Cockpit Validation Kit can ease the burden of validating your Cockpit environment.

Workflow

Discover the ins and outs of the comprehensive configurable workflow capabilities within Cognition's Cockpit Platform.