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Transcript of 2012 03 19 webinar
© International Institute of Business Analysis
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IIBA® Pharma/Biotech SIG Monthly Webinar
What about ...? What I wished I had asked the regulatory and testing people.
March 19, 2012
Griffin Jones, Congruent
Compliance
Agenda
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Today’s Presentation
© International Institute of Business Analysis
• 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
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What about ...? What I wished I had asked the regulatory and testing people.
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?
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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
Goal for this Webinar
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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
Introduction and Overview
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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
How to Do Perfect Testing
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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 doesn't 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.
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The Big Book of How to Do Perfect Testing“If you would succeed, know why you do what you do.”
James Bullock © 2004, 2006
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 don't have eager
customers, your testing is irrelevant. If you work at creating artifacts, especially software, and
your testers aren't your best friends why are you so sure you are right?
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The Big Book of How to Do Perfect Testing“If you would succeed, know why you do what you do.”
James Bullock © 2004, 2006
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 aren't 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.
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The Big Book of How to Do Perfect Testing“If you would succeed, know why you do what you do.”
James Bullock © 2004, 2006
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.
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Questions? Comments?
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/
CommitteeDocuments.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.
The FDA’s initial thinking on the use of Agile practices
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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
Five Recommendations
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This is an important document!Read the detailed recommendations
as soon as you can.
Has anyone else had access to the document?
Who else has started implementing Agile practices? What works well? Challenges?
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Questions? Comments?
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/
Why testing experts disagree
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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
Why testing experts disagree
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I find the school model to be useful to explain my behavior, or as a line of inquiry to understand someone else’s behavior.
I find “Standard” and “Quality” schools are common in Pharma/Biotech industries
Think about what school you might belong to, and why. Perhaps you are a blend? (Griffin shares his school)
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Questions? Comments?
What questions do you have?
Questions from the Audience
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Pre-Questions
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Safe and Effective Risk-based Under Control Accountability Data driven decisions
The real intent of FDA regulations
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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
User acceptance testing practices
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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 for21CFR Part 11 Electronic Records; Electronic Signatures?
Eliciting requirements specific to regulations
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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
Best practices to document requirements
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How those changes are documented◦ Follow your processes◦ If your processes are broken/unsustainable –
expose the pain to help get the processes fixed.
Dealing with change control in a validated solution
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What is different in the Pharma/Biotech world related to verification & testing?
What is the same?
Verification and Testing in Pharma/Biotech
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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/
How to do theses?
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The regulatory is not your business partner
The regulatory has police powers See my other presentation
◦ http://www.associationforsoftwaretesting.org/?dl_name=What_do_auditors_expect_from_testers_-_Griffin_Jones.pdf
Regulatory risks to business
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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_auditors_expect_from_testers_-_Griffin_Jones.pdf
Audit Survival Heuristics
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Griffin Jones
Congruent [email protected]
Thank you for attending
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Thank you for attending!
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