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CSA Revolution Series: Computer Software Assurance
DIRECT FROM THE SOURCE
FDA - INDUSTRY CSA TEAM
FICSA Team
Fresenius CSA Journey Panel Discussion (With team members from FDA & Siemens)
"Episode 3” - Live Webinar Series, Thursday August 6 th, 2020
Khaled Moussally (Host)
EVP, Clients & Regulatory Relations – COMPLIANCE GROUP
Marc Koetter
Sr. Manager, IT FRESENIUS
Francisco (Cisco) Vicenty
Program Manager, Case for Quality
CDRH - FDA
Bill D’Innocenzo
SVP, Digital Integration Global Manufacturing,
Quality & Supply - FRESENIUS
Jason Spiegler Sr Director, Strategic Initiatives Life
Sciences Practice - SIEMENS
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PANELISTS
Marc KoetterSR. MANAGER, IT
Marc leads the IT Quality Assurance function at Fresenius Medical Care, which defines all corporatesoftware quality procedures, performs software quality assurance (testing), validation, andinfrastructure qualification. Additionally, he is a corporate quality systems auditor for ISO 13485,FDA CFR 820, MDSAP and other regulations. He is a multi-disciplined professional with extensiveexperience in quality engineering and quality management. He has been in the life science spacesince 2003 and has worked both on the manufacturer, vendor, and consulting sides of the business.Since 3 years he leads the quality assurance activities for Fresenius Medical Care´s program toharmonize and implement a standardized SAP system at >40 countries globally.Marc is a member of the “FDA – Industry CSA team” contributing to the FDA draft guidance“Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software”.
Bill D’InnocenzoSVP, DIGITAL INTEGRATION GLOBAL MANUFACTURING, QUALITY & SUPPLY
Bill D’Innocenzo, SVP Digital Integration works within the Global Manufacturing, Quality andSupply group at Fresenius Medical Care. Bill is a life-long process improvement professional withmore than 35 years of experience. He leverages the principles, tools and techniques of continualprocess improvement to help organizations deliver bottom line sustainable results and drivesignificant business value.He began his career in Research & Development, later moving into Manufacturing Operation roles;developing and refining his skills in the disciplines of industrial, process and test engineering.Process and operational excellence is the cornerstone of Bill’s focus – getting the right peopleworking on the right projects and tasks employing effective processes are critical to anorganization’s success. He seeks to achieve the proper balance to leverage the people, processand technology triad. Deploying simple, yet highly effective and efficient processes is always thetargeted result.Bill has held various senior and executive level positions in R&D, Quality Assurance andManufacturing Operations for high-tech and medical device manufacturing. He has establishedhimself as a change agent focused on organizational behaviors and culture that deliver highperformance and achieve sustainable, long-term results.
Khaled MoussallyExecutive Vice President CLIENTS & REGULATORY RELATIONS
Khaled is a Quality & Compliance executive and a thought leader providing cutting-edge solutions to Life Sciences industry. Afterspending over 25+ years with corporate in IT, Manufacturing and Quality, Khaled transitioned into consulting to bring about aparadigm shift in Quality & Compliance by leveraging his experience with regulatory agencies. Khaled is a key participant of the MDIC“Case for Quality Initiatives” and a member of the “FDA – Industry CSA team” contributing to the FDA draft guidance “ComputerSoftware Assurance (CSA) for Manufacturing, Operations, and Quality System Software”. Khaled is on the “ISPE GAMP AmericaSteering Committee” and has co-presented with the FDA in numerous industry conferences on how to reduce CSV cycle times whileenhancing quality by applying CSA concept.
FDA - Industry CSA (FICSA) Team Members
Cisco Vicenty is currently the Program Manager for the Case for Quality (CfQ) within the Office of Compliance, Center for Devices andRadiological Health (CDRH), FDA. This effort is part of the CDRH strategic priorities for 2016 and 2017and will improve access andpatient outcomesby engaging industry, payers, providers, and patients to increase focus on the quality and performance of medical devices.Cisco began at the FDA as a compliance officer in the Cardiac Rhythm and Electrophysiology Branch in the Office of Compliance atCDRH. He then worked as a project manager for the FDA’s Case for Quality initiative. Prior to his current role, Cisco was the BranchChief of the Respiratory, E/N/T, General Hospital, and Ophthalmic Devices Branch in the Division of Manufacturing and Quality, withinthe Office of Compliance.
Francisco (Cisco) Vicenty PROGRAM MANAGER, CASE FOR QUALITY, CDRH
Jason SpieglerSR DIRECTOR, STRATEGIC INITIATIVES LIFE SCIENCES PRACTICE
Jason has worked in the Life Sciences and Technology industries for 22 years in various Quality, Business Development, and SalesManagement roles. Prior to Siemens, Jason worked for Johnson and Johnson, and several medical device start-up companies. In his laststart-up, he served as the Head of Quality, responsible for implementing all elements of the Quality System and executing their qualitystrategy with all external partners.Jason has been with Siemens Digital Industries for 13 years. He is responsible for leading many of their strategic activities between FDAand customers within the Life Sciences practice. Jason is also responsible for the customer experience at several strategic customers. Heis especially passionate about partnering to reframe big problems to create more transformative impactful solutions, leveraging bothleadership and technology.
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Agenda
❑ Meet the “FDA- Industry CSA Team”(FICSA) Members!
❑ FICSA TEAM Journey
❑ Fresenius CSA Journey & Implementation
Objectives
❑ Don’t wait for the FDA Draft Guidance to be released
➢ Start thinking how you want to implement CSA
➢ Pilot Studies Effective
➢ Digitize your current paper CSA processes
❑ Create awareness to accelerate innovation
❑ Inspire action so you can begin to realize value
❑ Next Steps
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• Recorded Webinar - CSA Game Changer Webinar with the Cisco Vicenty from FDA Click Here
• Webinar Material - Click Here
• CG/ CSA White Paper -
CSA Revolution Series
Game Changer Kick Off Webinar Series
Was back on April 23rd, 2020
FDA - Industry CSA (FICSA) Team Members
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How did the CSA Initiative begin?
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www.fda.gov
CSV identified as a barrier for the FDA…
For your technology
investments, what are the
barriers for Realizing Value?
CSV!!!
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Cultural Barriers Paralyzing Industry
Summary of Impact
• Manufacturers are reluctant to invest
• When they invest, the documentation
burden is excessive (not commensurate
with Risk) impacting “Time to Value”
• Cybersecurity (Enterprise) risk increases
➢ Slow to upgrade/ implement patches due
to “revalidation” lifecycle burden
• Impacts all Centers across FDA!
“We are risk-based… everything is high risk!”
“Too much documentation – lot of overhead for little value!”
“Most deviations are documentation errors, not Software bugs - we trip over ourselves!”
“We validate all Software… like product Software!”
“Data mining? We looked at purchasing an inexpensive BI tool, but CSV cost was too high.”
“The real pain no one discusses, is the CSV burden over the lifecycle of maintaining software.”
“It took 4x longer for CSV than the actual analysis!”
“What If analysis not practical to maintain”
For software not used in product, manufacturers refer to significantly more burdensome guidance (20+ years old),
based on Fear of a 483, based on prior FDA Investigations and 3rd Party Consultants.
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Contributions also provided by past team members:Stacey Allen, Jason Aurich, Sean Benedik, Laura Clayton, Bill Hargrave, Joe Hens, Scott Moeller, John Murray, Penny Sangkhavichith, Dana Guarnaccia, and Curt Curtis.
FDA - Industry CSA Team (FICSA)
Company Name
Baxter Healthcare Tina Koepke
Boston Scientific Damien McPhillips
Boston Scientific Ray Murphy
Compliance Group Khaled Moussally
Edwards Lifesciences Andy Lee
FDA Cisco Vicenty
Fresenius Medical Care Bill D'Innocenzo
Fresenius Medical Care Marc Koetter
Gilead Sciences Ken Shitamoto
Gilead Sciences Senthil Gurumoorthi
Johnson and Johnson Ron Schardong
Company Name
Johnson and Johnson Reggie George
Lantheus Imaging Lou Poirier
Medtronic Frankie Bill
Medtronic Michael Branch
Medtronic April Francis
NeuroVision Imaging Pepe Davis
Ortho-Clinical Diagnostics Des Chesterfield
Siemens Digital Industries Jason Spiegler
Siemens Digital Industries Greg Robino
Roche Thorsten Ruehl
Omnicell Frank Meledandri Sr.
Join FICSA LinkedIn Group
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GMQS TRANSFORMATION FROM CSV TO CSA
FRESENIUS MEDICAL CARE (FMC)
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8/6/2020 Page 10
FRESENIUS MEDICAL CARE (FMC) INTERNAL CONCERNS TO IMPLEMENT CSA
“This does not comply to existing best
practices like GAMP5“
“Every stakeholder incl. QA need to sign relevant documents“
“FDA expects to test the whole
software.”
“We should wait until the FDA guidance
is officially released“
“This is only recognized by the FDA.
How about other regulatory bodies like
e.g. those in the EU?”
“No test evidence does not follow FDAs
requirement „what is not documented is
not done“.
“We should better be conservative and
follow common best practices to assure
compliance“
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CSA DOCUMENTATION
✓ Establish unscripted and
l imited scripted testing
✓ Remove evidence capturing
(e.g. screenshots) if not
necessary
Test Execution and
Result Documentation
THREE PILLARS OF TRANSFORMATION FROM CSV TO CSA
✓ Change document templates
into Forms
✓ Merge templates
✓ Remove redundant information
SIGNATURES
✓ Reduce amount of mandatory
signatures to only one creator
and one independent reviewer
✓ Remove mandatory QA
signatures
✓ Ensure QA via quality gate
reviews instead of reviewing
every document
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Next Steps
❑ Don’t wait for the FDA Draft Guidance to be released
➢ Start thinking how you want to implement CSA
➢ Pilot Studies Effective
➢ Digitize your current paper CSA processes (See appendix)
❑ Create awareness to accelerate innovation
❑ Inspire action so you can begin to realize value
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COMPANY DATE EPISODE # TOPIC /GUEST(S)
August 20th 4
Open discussion with Francesca Bill - walking through a Medtronic CSA Case Study Automating
Risk Based
September 3rd 5
Open discussion with Ray Murphy & Damien McPhillips - walking through a Boston Scientific
CSA Case Study for PM/Calibration System
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FDA - Industry CSA (FICSA) Webinar’s Schedule
Register Here Episode 4
August 20th
BONUS MATERIAL / APPENDIX SLIDES
The Meat - “FDA - Industry CSA Team Recommendations”
Note: All of these recommendations are within FDA
Regulations!
www.fda.gov
What does FDA care about?Risk Considerations
• Direct impact to device quality and device safety thatalso has a direct patient safety risk
• Directly impacts physical properties of the product or manufacturing process identified as essential to device safety or device quality by the manufacturer
• Measures, inspects, analyzes, and or dispositions the product or process
• Determines acceptability or performs process correctionswithout human intervention, awareness, or review
• Directly impacts labeling, instructions for use, or directalerts or communications to the user
• Automates surveillance, trending, or tracking of product quality or patient safety issues identified as essential by the manufacturer
16
www.fda.gov
Appropriate methods and activities for software assurance
• Take a least-burdensome approach – focus on value for the Manufacturer, not the Investigator.
• Leverage existing activities and supplier data. Do not reinvent the wheel; takecredit for work already done
• Leverage use of process controls to mitigate risk
• Use Computer System Validation tools to automate assurance activities
➢ Scope of 21 CFR 820.70(i) is applied when computers or automated data processingsystems are used as part of production or quality system.
➢ FDA does not intend to review validation of support tools. Manufacturer determines assurance activity of these tools for their intended use.
➢ Part 11 narrowly scoped and is under enforcement discretion apply appropriately
• Use Agile testing methods and unscripted testing as appropriate
• Use electronic data capture and record creation, as opposed to paper documentation, screen shots, etc
• Leverage continuous data and information for monitoring and assurance
17
www.fda.govwww.fda.gov
Acceptable record of resultsAssurance Approach Test Plan Test Results Record (Digital Acceptable)
Unscripted Testing: Ad-hoc (with least-burdensome documentation)
• Testing of features and functions with no test plan
• Details regarding any failures/deviations found
• Summary description of features and functions tested• Issues found and disposition• Conclusion statement• Record of who performed testing and date
Unscripted Testing:Error guessing
• Testing of feature and function fail-modes with no test plan
• Details regarding any
failures/deviations found• Summary description of fail-modes tested• Issues found and disposition• Conclusion statement• Record of who performed testing and date
Unscripted Testing:Exploratory Testing
• Establish high level test plan objectives for features and functions (no step-by-step procedure is necessary)
• Pass/fail for each test planobjective
• Details regarding any failures/deviations found
• Summary description of features and functions tested• Result for each test plan objective – only indication of pass/fail• Issues found and disposition• Conclusion statement• Record of who performed testing and date
Scripted Testing:Limited
• Limited Test cases (step-by-step procedure) identified
• Expected results for the test cases• Identify unscripted testing applied• Independent review and approval of
test plan.
• Pass/fail for test case identified• Details regarding any
failures/deviations found and disposition regarding fails
• Summary description of features and functions tested• Result for each test case - only indication of pass/fail• Issues found and disposition• Conclusion statement• Record of who performed testing and date• Signature and date of appropriate signatory authority
Scripted Testing:Robust
• Test objectives
• Test cases (step-by-step procedure)
• Expected results
• Independent review and approval of
test cases.
• Pass/fail for test case• Details regarding any
failures/deviations found and disposition regarding fails
• Detailed report of assurance activity• Result for each test case - only indication of pass/fail• Issues found and disposition• Conclusion statement• Record of who performed testing and date• Signature and date of appropriate signatory authority
PAPERLESS VALIDATION TOOL
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