IIBA® Pharma/Biotech SIG    Monthly Webinar                                                                       What abo...
Agenda• Welcome & Announcements• Presentation   “What about ...? What I wished I had asked the regulatory and    testing ...
Welcome• Today’s IIBA Pharma/Biotech SIG Staff    Host       Michael Calluori (Sanofi), VP of the Community    Question...
Join the Community• Starting April 2012    Closed webinars (not public)    Must be an IIBA® member• Join the Community  ...
Volunteer• Help Needed – Open Positions   VP of Event Planning   VP of Communications                           © Intern...
Tell us what you think…• We want to know what you think about our webinars• We want to know you would like in the future• ...
Who to ContactPlease contact one of the board members listed below:          Michael Calluori: VP, Community            Mi...
Other Board Members      Carol Scalice: President         Carol.Scalice@pfizer.com      Matthew St. Louis: VP, Marketing  ...
Next Webinar• Pre-Competitive Collaborations: The Pistoia Alliance    John Wise, Executive Director, Pistoia Alliance   ...
Today’s Presentation• What about ...? What I wished I had asked the regulatory  and testing people.    Speaker: Griffin J...
Requirements Analysis (Chapter 6 in the BABOK® Guide)describes the business analysts’ role in the verification      and va...
   Outline three current topics relevant to the    tester and regulatory roles   Opportunity to ask your questions   Le...
   Introduction    ◦ SW Testing and Regulatory Compliance    ◦ Medical devices and Clinical Research Organization   Thre...
   James Bullock’s “The Big Book of Perfect    Testing”    ◦ http://www.qasig.org/past_meetings.html      Review James’s...
   1 - Testing is an informational function.    ◦ You are paying to learn something.      Any time your bury or misinter...
   3 - Information is valuable if you act on it.    ◦ Otherwise it is entertainment. So, each bit of information      pro...
   4 - The techniques of testing are endless - literally.    ◦ The correct technique is the one that best gets you the   ...
    Is there one principle that resonates with you?1.    Testing is an informational function.        You are paying to l...
   Search for the current draft of AAMI Agile TIR    SW Committee’s    ◦ “Guidance on the use of AGILE practices in the  ...
   Agile adds value and can be adapted to this    context   The values of AGILE add to the QMS values   Demonstrate how...
 Has   anyone else had access to the document? Who else has started implementing Agile practices? What works well? Chall...
   Schools of Software Testing    ◦ Share some of Bret Pettichord’s slide deck    ◦ http://www.prismnet.com/~wazmo/papers...
   Recent separation in the Context-Driven school    ◦ Cem Kaner       http://context-driven-testing.com/?page_id=9    ◦...
IIBA Pharma/Biotech SIG   3/19/2012   24
IIBA Pharma/Biotech SIG   3/19/2012   25
IIBA Pharma/Biotech SIG   3/19/2012   26
IIBA Pharma/Biotech SIG   3/19/2012   27
IIBA Pharma/Biotech SIG   3/19/2012   28
IIBA Pharma/Biotech SIG   3/19/2012   29
IIBA Pharma/Biotech SIG   3/19/2012   30
IIBA Pharma/Biotech SIG   3/19/2012   31
IIBA Pharma/Biotech SIG   3/19/2012   32
IIBA Pharma/Biotech SIG   3/19/2012   33
IIBA Pharma/Biotech SIG   3/19/2012   34
Ifind the school model to be useful to explain my behavior, or as a line of inquiry to understand someone else’s behavior...
   What questions do you have?                           IIBA Pharma/Biotech SIG   3/19/2012   36
IIBA Pharma/Biotech SIG   3/19/2012   37
   Safe and Effective   Risk-based   Under Control   Accountability   Data driven decisions                          ...
   Is it really an FDA or regulator requirement    that users have to do scripted system testing?    ◦ No. Why people thi...
   are they documented?   where do we find them?   how should we document or refer to them in    our requirements?    ◦...
   How to “cover yourself” in case you are    audited?    ◦ YOU are the expert    ◦ Explain why what you are doing is suf...
   How those changes are documented    ◦ Follow your processes    ◦ If your processes are broken/unsustainable –     expo...
   What is different in the Pharma/Biotech world    related to verification & testing?   What is the same?              ...
   Blending regulatory compliance with Agile    practices to create sustainable validation    compliance   Validation so...
   The regulatory is not your business partner   The regulatory has police powers   See my other presentation    ◦ http...
   I have another presentation that may be    helpful for FDA regulated project teams    members    ◦ “What do auditors e...
Griffin Jones    Congruent ComplianceGriffin.Jones@CongruentCompliance.com                    IIBA Pharma/Biotech SIG   3/...
Thank you for attending!• Next Webinar    “Pre-Competitive Collaborations: The Pistoia Alliance” – John     Wise, Executi...
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2012 03 19 webinar

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Recording of the March 19, 2012 IIBA Pharma/Biotech Special Interest Group Webinar given by Griffin Jones, titled What about...? What I wished I had asked the regulatory and testing people.

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2012 03 19 webinar

  1. 1. IIBA® Pharma/Biotech SIG Monthly Webinar What about ...? What I wished I Cover this area with a had asked the picture related to your regulatory and presentation. It can be humorous. testing people. Make sure you look at the Notes Pages for March 19, 2012 more information about how to use the Griffin template. Jones, Congruent Compliance © International Institute of Business Analysis
  2. 2. Agenda• Welcome & Announcements• Presentation  “What about ...? What I wished I had asked the regulatory and testing people.”• Q&A © International Institute of Business Analysis
  3. 3. Welcome• Today’s IIBA Pharma/Biotech SIG Staff  Host  Michael Calluori (Sanofi), VP of the Community  Question Moderator  Carol Scalice (Pfizer), President  Webinar Administrators  Matt St. Louis (Pfizer), VP of Marketing  Jim Blay (Covance), VP of Technology © International Institute of Business Analysis
  4. 4. Join the Community• Starting April 2012  Closed webinars (not public)  Must be an IIBA® member• Join the Community  http://community.iiba.org/pharmabiotechsig  No additional cost © International Institute of Business Analysis
  5. 5. Volunteer• Help Needed – Open Positions  VP of Event Planning  VP of Communications © International Institute of Business Analysis
  6. 6. Tell us what you think…• We want to know what you think about our webinars• We want to know you would like in the future• Look for a survey from us in the near future, we promise it will be very brief and we really want to know what you think! © International Institute of Business Analysis
  7. 7. Who to ContactPlease contact one of the board members listed below: Michael Calluori: VP, Community Michael.Calluori@sanofi-aventis.com Mike Horn: VP, Membership michael.horn@astrazeneca.com Leah Estberg: VP, Sponsorship Leah.Estberg@aphis.usda.gov © International Institute of Business Analysis
  8. 8. Other Board Members Carol Scalice: President Carol.Scalice@pfizer.com Matthew St. Louis: VP, Marketing matthew.v.st.louis@pfizer.com Jim Blay: VP, Technology james.blay@covance.com © International Institute of Business Analysis
  9. 9. Next Webinar• Pre-Competitive Collaborations: The Pistoia Alliance  John Wise, Executive Director, Pistoia Alliance  Monday, April 30th, 11a-12p EST  Register Today  https://www2.gotomeeting.com/register/227390282• Call for Speakers  Send us your topic ideas and submissions today! © International Institute of Business Analysis
  10. 10. Today’s Presentation• What about ...? What I wished I had asked the regulatory and testing people.  Speaker: Griffin Jones  Owner & Principal Consultant, Congruent Compliance• Q&A  “Raise Hand”  Chat Window © International Institute of Business Analysis
  11. 11. Requirements Analysis (Chapter 6 in the BABOK® Guide)describes the business analysts’ role in the verification and validation of requirements. During that task, business analysts’ are in direct contact with the stakeholder roles of tester and regulator. Why are those roles special in an FDA regulated context, and how can a business analyst more effectively interact with them? IIBA Pharma/Biotech SIG 3/19/2012 11
  12. 12.  Outline three current topics relevant to the tester and regulatory roles Opportunity to ask your questions Leave with a better understanding and empathy for the concerns and issues of testing FDA regulated products and services IIBA Pharma/Biotech SIG 3/19/2012 12
  13. 13.  Introduction ◦ SW Testing and Regulatory Compliance ◦ Medical devices and Clinical Research Organization Three current topics in Testing & Regulatory ◦ How to do Perfect Testing  Jim Bullock’s simple summary ◦ The FDA’s initial thinking on Agile practices  Summary of AAMI Agile TIR SW Committee’s “Guidance on the use of AGILE practices in the development of medical device software” ◦ Why testing experts disagree  Status on the “Schools of Testing” conversation Audience Questions IIBA Pharma/Biotech SIG 3/19/2012 13
  14. 14.  James Bullock’s “The Big Book of Perfect Testing” ◦ http://www.qasig.org/past_meetings.html  Review James’s Five Principles Follow up with Jerry Weinberg’s ◦ Perfect software: And Other Illusions about Testing  Read it yourself, then share it with others IIBA Pharma/Biotech SIG 3/19/2012 14
  15. 15.  1 - Testing is an informational function. ◦ You are paying to learn something.  Any time your bury or misinterpret information you get from testing you are corrupting what you are paying for. 2 - Testing produces information reliably grounded in the observed behavior of a system. ◦ Observation is what separates testing from analysis, induction, deduction and speculation.  Any time you argue yourself out of an observation because what you see "just doesnt make sense" or create circumstances that corrupt the observing, you are defeating the purpose of testing.  One of the most powerful observations that can come from testing is noticing what is not being, or cannot be reliably observed. Bury that information at your peril. IIBA Pharma/Biotech SIG 3/19/2012 15
  16. 16.  3 - Information is valuable if you act on it. ◦ Otherwise it is entertainment. So, each bit of information produced by testing needs a customer; a willing, enthusiastic customer eager to use the information they hope to get from testing to do a better job.  If you are a tester without customers, your job description is inoperative.  If you are a manager whose testers dont have eager customers, your testing is irrelevant.  If you work at creating artifacts, especially software, and your testers arent your best friends why are you so sure you are right? IIBA Pharma/Biotech SIG 3/19/2012 16
  17. 17.  4 - The techniques of testing are endless - literally. ◦ The correct technique is the one that best gets you the information you need to take a better next step than you would otherwise.  If you are stuck on a technique rather than the results, you have descended into ritual.  If you or your testers are unwilling to discover, embrace or if need be invent whatever technique it takes to find the information you need, you arent doing testing, you have descended into administration. ◦ So what do you really want to know about your system, and how do you find that out? 5 - Act always according to these four principles and you will do perfect testing, every time. ◦ The rest is details. IIBA Pharma/Biotech SIG 3/19/2012 17
  18. 18.  Is there one principle that resonates with you?1. Testing is an informational function. You are paying to learn something.2. Testing produces information reliably grounded in the observed behavior of a system.3. Information is valuable if you act on it.4. The techniques of testing are endless - literally. Take a better next step.5. Act always according to these four principles. IIBA Pharma/Biotech SIG 3/19/2012 18
  19. 19.  Search for the current draft of AAMI Agile TIR SW Committee’s ◦ “Guidance on the use of AGILE practices in the development of medical device software”  http://www.aami.org/committeecentral/Committee/CommitteeDocume nts.cfm?ComID=0SW0000 (Note that access to the doc is currently restricted) Expect that this will be applied across all SW ◦ regulated by FDA & other non-US regulatory bodies For AGILE to be established in the medical device software industry, guidance is needed to adapt it to fit that unique context. IIBA Pharma/Biotech SIG 3/19/2012 19
  20. 20.  Agile adds value and can be adapted to this context The values of AGILE add to the QMS values Demonstrate how your incremental SW dev. lifecycle satisfies regulatory requirements Agile needs strong change management systems Agile needs a functioning QMS to live inside This is an important document! Read the detailed recommendations as soon as you can. IIBA Pharma/Biotech SIG 3/19/2012 20
  21. 21.  Has anyone else had access to the document? Who else has started implementing Agile practices? What works well? Challenges? IIBA Pharma/Biotech SIG 3/19/2012 21
  22. 22.  Schools of Software Testing ◦ Share some of Bret Pettichord’s slide deck ◦ http://www.prismnet.com/~wazmo/papers/four_schools .pdf Debate: Are Testing “Schools” a good idea? – Doug Hoffman & James Bach ◦ http://www.associationforsoftwaretesting.org/2012/03/08/debate- are-testing-schools-a-good-idea-doug-hoffman-james-bach/ IIBA Pharma/Biotech SIG 3/19/2012 22
  23. 23.  Recent separation in the Context-Driven school ◦ Cem Kaner  http://context-driven-testing.com/?page_id=9 ◦ James Bach  http://www.satisfice.com/blog/archives/724 ◦ Michael Bolton  http://www.developsense.com/blog/2012/03/i-might-be- wrong/ ◦ Scott Barber  http://scott-barber.blogspot.com/2012/02/is-testing- dead-dunno-but-context.html ◦ Matthew Heusser  http://xndev.blogspot.com/2012/03/lets-call-calling-off- off.html IIBA Pharma/Biotech SIG 3/19/2012 23
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  35. 35. Ifind the school model to be useful to explain my behavior, or as a line of inquiry to understand someone else’s behavior.Ifind “Standard” and “Quality” schools are common in Pharma/Biotech industries Thinkabout what school you might belong to, and why. Perhaps you are a blend?  (Griffin shares his school) IIBA Pharma/Biotech SIG 3/19/2012 35
  36. 36.  What questions do you have? IIBA Pharma/Biotech SIG 3/19/2012 36
  37. 37. IIBA Pharma/Biotech SIG 3/19/2012 37
  38. 38.  Safe and Effective Risk-based Under Control Accountability Data driven decisions IIBA Pharma/Biotech SIG 3/19/2012 38
  39. 39.  Is it really an FDA or regulator requirement that users have to do scripted system testing? ◦ No. Why people think/say that is interesting. Been trying to push back because what they have been doing as UAT is really just users doing functional system testing. ◦ All that tells you is whether the systems fulfills the requirements ◦ It doesn’t tell you if the user actually accepts and can use the solution delivered. ◦ Agree - See Jim Bullock’s five principles IIBA Pharma/Biotech SIG 3/19/2012 39
  40. 40.  are they documented? where do we find them? how should we document or refer to them in our requirements? ◦ How do you currently handle the regulatory requirements for 21CFR Part 11 Electronic Records; Electronic Signatures? IIBA Pharma/Biotech SIG 3/19/2012 40
  41. 41.  How to “cover yourself” in case you are audited? ◦ YOU are the expert ◦ Explain why what you are doing is sufficient ◦ Too many requirements or too much detail is as bad as too little detail IIBA Pharma/Biotech SIG 3/19/2012 41
  42. 42.  How those changes are documented ◦ Follow your processes ◦ If your processes are broken/unsustainable – expose the pain to help get the processes fixed. IIBA Pharma/Biotech SIG 3/19/2012 42
  43. 43.  What is different in the Pharma/Biotech world related to verification & testing? What is the same? IIBA Pharma/Biotech SIG 3/19/2012 43
  44. 44.  Blending regulatory compliance with Agile practices to create sustainable validation compliance Validation solutions that are practical and tailored to their business model context Alternative options to difficult software validation problems ◦ E.g., Quintiles white paper: “The Art of Compliance”  http://www.quintiles.com/information-library/white- papers/sustainable-regulatory-compliance/ IIBA Pharma/Biotech SIG 3/19/2012 44
  45. 45.  The regulatory is not your business partner The regulatory has police powers See my other presentation ◦ http://www.associationforsoftwaretesting.org/?dl_name=What_do_auditor s_expect_from_testers_-_Griffin_Jones.pdf IIBA Pharma/Biotech SIG 3/19/2012 45
  46. 46.  I have another presentation that may be helpful for FDA regulated project teams members ◦ “What do auditors expect from testers?  The audit survival heuristics of an FDA regulated exploratory testing team”  http://www.associationforsoftwaretesting.org/?dl_name=What_do_audit ors_expect_from_testers_-_Griffin_Jones.pdf IIBA Pharma/Biotech SIG 3/19/2012 46
  47. 47. Griffin Jones Congruent ComplianceGriffin.Jones@CongruentCompliance.com IIBA Pharma/Biotech SIG 3/19/2012 47
  48. 48. Thank you for attending!• Next Webinar  “Pre-Competitive Collaborations: The Pistoia Alliance” – John Wise, Executive Director, Pistoia Alliance  Monday, April 30th, 11a-12p EST  Register: https://www2.gotomeeting.com/register/227390282• Contact the President: Carol.Scalice@pfizer.com  Topic ideas and speaker submissions  Volunteering – Communications, Event Planning  Joining the Community• Look for our survey in the near future! © International Institute of Business Analysis

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