Topic: Automating Risk-Based CSA Case Study
FDA CDRH Fiscal Year 2020 (FY 2020) Proposed Guidance Development
Cultural Barriers Paralyzing Industry
Common Issues with current paper-based process
Risk Assessment: FMEA (because Big Brother expects it, right?)
Risk Assessment with CSA
Risk Assessment with Siemens Polarion & CSA: a combination of Paperless ALM system and CSA concept, resulting in many efficiencies.
PAVING the WAY FOR A NEW QUALITY CULTURE: RISK-BASED TESTING FOR IT SOFTWARE
IT Quality pain points & solutions

Objectives of webinar series:
Start thinking about how you want to implement CSA
Digitize your current paper CSA processes
Create awareness to accelerate innovation and realize value
Why you shouldn't wait for the FDA Draft Guidance to be released
0:00 Introductions
0:07 FDA-Industry CSA (FICSA) Team Members
3:01 Agenda&Objectives
6:04 FDA - Industry CSA Team (FICSA)
6:48 FDA CDRH Fiscal Year 2020 (FY 2020) Proposed Guidance
7:50 CSA Revolution Series By the FDA - Industry CSA Team (FICSA)
8:35 Cultural Barriers paralyzing Industry
14:48 CSV Customer Example
20:28 Risk Assessment:FMEA (because Big Brother expects it, right?)
24:03 Risk Assessment:CSA
26:29 Risk Assessment:Polarion/CSA
28:19 PAVING THE WAY FOR A NEW QUALITY CULTURE
29:00 CSA Customer Example
31:57 CSA RISK MANAGEMENT AUTOMATION POLARION
33:21 IT QUALITY PAIN POINTS & SOLUTIONS
36:10 POLARION RISK BASED TESTING
39:56 POLARION LOGIC FOR 'TEST STANDARD' CUSTOM FIELD
44:27 NEXT STEPS
46:43 FDA - Industry CSA (FICSA) Webiner's Schedule
48:35 Questions?
52:20 POLARION RISK BASED TESTING
56:50 QUESTIONS?