Guided Approach White Papers
Cockpit, 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 we can help you.
Design Controls Template
Cockpit's Design Controls Template
The Design Controls Template runs on the powerful Cockpit Platform. Using this template, teams are guided through the process of Design Controls as defined by FDA in 21 CFR 820.30.
Cockpit's Preliminary Hazard Analysis Template
The PHA Template runs on the powerful Cockpit Platform. Using this template, teams are guided through the process of completing a PHA exercise as outlined in commonly followed standards.
How to approach Usability Engineering & Use Error Analysis
FDA and Notified Bodies are encouraging your organization to focus more time and energy into Usability Engineering/Human Factors Engineering. But where do you start? How do you tackle the many ways in which your device might be used? And what are good risk activities to include in your design process?
Read about each of these topics and how activities like Use Error Analysis can lead to more dynamic, impactful risk management.
Design Control 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.
Risk Management and Usability
The first paper in the series is a systematic review of 483 data and common breakdowns in 21 CFR 820.30 (c) and (d). Risk Management and Usability are key factors to the success of product design, making them a focus point in the Design Controls discussion.
The second paper 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.
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).
The fourth 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).
Verification and Validation
The fifth 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).
The sixth 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).
The seventh 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).
General Cockpit White Papers
Practical Approaches to meeting 21 CFR 820.30(e)
One of the most complex decisions your team has to make surrounding Design Control regulations is determining a strategy for 21 CFR 820.30(e) – Design Review. FDA investigators assess design review processes during premarket submissions to determine that the product development team’s method achieves safety.
Cockpit as SaaS
Cockpit as Software-as-a-Service offering
Learn how Synergio’s Software-as-a-Service offerings can help remove IT burden while empowering your product development process.
Learn more about Cockpit's Validation Kit
Download the 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.
Learn more about configurable Workflow in Cockpit
Discover the ins and outs of the comprehensive configurable workflow capabilities within the Cockpit Platform.
Download the Critical-to-Quality Flowup white paper
If you found “Understanding Critical-to-Quality (CTQ) Flowdown” valuable, the follow-up about CTQ Flowup will be equally interesting for you!
As the second half of the overall CTQ process, flowup activities look at assessing CTQ performance and its impact/relationship to other requirements. The white paper explores the basics of CTQ Flowup, methods for evaluating critical parameter performance, and the benefits of implementing flowup processes into your product development process.