The intent of the Computer Software Assurance Alliance (CSAA) is to support and engage with the FDA – Industry CSA team (FICSA) that creates and provides presentations, videos, case studies, blogs and new examples to educate and promote the adoption of risk based CSA and critical best practices for the Life Sciences industry.

The objective of CSA is to apply critical thinking for assessing the risks of the computer software for patient safety and product quality (but not compliance), to drive a streamlined and effective test assurance strategy. Based on the risk based CSA approach and through the use of different test assurance approached (e.g. “unscripted testing”), manufacturers are able to significantly reduce the time and labor required, while increasing the testing to ensure a more robust software system.

Series Kick off Game Changer! Everything about FDA’s Upcoming Guidance on Computer Software Assurance (April 23)

  • Francisco Vicenty discusses the cultural barriers paralyzing the life science industry
  • Updates on the upcoming FDA draft guidance on CSA
  • FDA draft guidance’s alignment to ISPE GAMP.

Episode 1: CSA Journey by Gilead Sciences (July 9)

  • Necessary risk assessed
  • Trends w/ confidence towards product quality and patient safety
  • Moving towards real-time monitoring

Episode 2: CSA MES w/ Johnson & Johnson (July 23)

  • MES = Manufacturing Execution System
  • CSA Pilot Strategy Definition
  • CSV Activities & Impact
  • Streamlining CSV & Enabling High-Quality Manufacturing (MES)

Episode 3: CSA Journey from CSV to CSA by Fresenius Medical Care (Aug. 6)

  • Includes panelist discussion w/ Cisco Vicenty at FDA & Jason Spiegler at Siemens Life Sciences
  • Internal Concerns to Implementing CSA
  • (3) Pillars of Transformation from CSV to CSA

Episode 4: CSA Automation with Medtronic (Aug. 20)

  • Risk Assessment with CSA
  • Risk Assessment with Siemens Polarion + CSA: combination of Paperless ALM system and CSA concept, resulting in many efficiencies

Episode 5: CSA Preventative Maintenance/Calibration System w/ Boston Scientific (Sept. 3)

  • Applying CSA Risk-Based Validation to Non-Device Software
  • Common CSV Pain Points, Implemented new Calibration & Preventative Maintenance software system to Drive Efficiency & Quality Improvements
  • Unscripted Testing, Ad-Hoc Testing, & Risk-Based Validation

Episode 6: CSA – Overcoming Cultural Barriers w/ Lantheus Medical Imaging (Sept. 17)

  • Special guest appearance by Cisco Vicenty at FDA – Upcoming Guidance update
  • Tell-tail responses from a conservative organization
  • Symptoms of conservative behavior
  • Tools & applications to overcome these barriers and tips to drive culture change

Episode 1: Data Integrity & CSA Experts (Nov. 18, 2020)

  • Discuss upcoming ISPE GAMP® Good Practice Guide (GPG), Data Integrity by Design and the CSA Appendix
    • Understand key requirements and essentials to address ongoing challenges
    • Learn to execute Data Integrity by Design for management of GxP regulated records & data

Episode 2: FDA/CDER Part One – CSA Application to Data Integrity (Jan. 26, 2021)

  • Data Integrity Challenges & Avoiding Compliance Issues
    • How CSA can be adapted to benefit your organization & applied to Data Integrity

Episode 3: FDA Part Two – Data Integrity: The Challenges & CSA Application (Mar. 16, 2021)

  • How CSA can be adapted to benefit your organization and application to Data Integrity
    • Importance of controls around application-related data
    • Most common FDA non-compliance findings, where DI guidance may not have covered

Episode 4: Transform Software Defects – J&J Case Study (Apr. 22, 2021)

  • When you do your software testing, and you have a bug or defect, script error, tester error
    • Do you treat them all the same?
    • Should you treat them all the same?

Episode 5: CSA Fast Pass to Automation (June 22, 2021)

  • Learn from different scenarios on how CSA has been implemented
    • Obtain helpful tips to push the CSA initiative internally at your organization
    • Overcome roadblocks such as where do I start or what should I expect

Episode 6: Risk-Based Approach & FMEA (Aug. 17, 2021)

  • Understanding the CSA Risk-based approach
    • When to use FMEA Vs CSA Risk assessment
    • The value of implementing CSA

If you have any questions or would like to get involved, please email