http://www.pcmag.com/article2/0,2817,2396632,00.asp
I wonder how bad the consequences will have to be before these problems that can't be ignored.
Friday, November 18, 2011
James Bach: “Transitioning to Context Driven Testing (from Other Schools)”
Birmingham Software Testing Club Meetup
Here’s James Bach speaking at the Meetup about “Transitioning to Context Driven Testing (from Other Schools)”.
http://sjpknight.com/2011/11/birmingham-software-testing-club-meetup-15112011-3-of-3/
... and a reference to the schools of testing: http://www.prismnet.com/~wazmo/papers/four_schools.pdf
Here’s James Bach speaking at the Meetup about “Transitioning to Context Driven Testing (from Other Schools)”.
http://sjpknight.com/2011/11/birmingham-software-testing-club-meetup-15112011-3-of-3/
... and a reference to the schools of testing: http://www.prismnet.com/~wazmo/papers/four_schools.pdf
Tuesday, November 15, 2011
Guidance on the use of AGILE practices in the development of medical device software - AAMI Technical Information Report - Working Committee Draft
I had the opportunity to see an advanced copy of the document from the Association for the Advancement of Medical Instrumentation .
Watch for the public version of this document, review it, and comment on it.
Agile TIR SW Committee Draft 1.0 10/7/2011 working draft
AAMI Technical Information Report AAMI/TIR XX:201X
Guidance on the use of AGILE practices in the development of medical device software
Abstract: Over the past several years, agile software development has become an accepted method for developing software products. There have been questions from both manufacturers and regulators as to whether (or which) agile practices are appropriate for developing medical device software. Enough medical device manufacturers have implemented agile practices in their software development that answers to these questions can be documented. Having clear guidance of what practices have been found to be appropriate will be very useful for all developers of medical device software. This TIR will provide recommendations for complying with international standards and United States Food and Drug Administration (FDA) guidance documents when using practices to develop medical device software.The paper describes how AGILE can bring value to medical device software, when adapted to the unique needs of medical devices.
Watch for the public version of this document, review it, and comment on it.
Sunday, November 13, 2011
Surviving an FDA Audit: Heuristics for Exploratory Testing
I am presenting at:
- KWSQA in Waterloo Canada on November 30th. http://www.kwsqa.org/meetings/default.asp
- Software Test Professionals Spring 2012, scheduled for March 26-29, 2012 in New Orleans, LA http://www.softwaretestpro.com/Item/5119/Save-the-Date!/
- STAREAST Software Testing Analysis & Review Conference April 15-20, 2012 Orlando, Florida http://www.sqe.com/stareast/
In FDA regulated industries, audits are high-stakes, fact-finding exercises required to verify compliance to regulations and an organization’s internal procedures. Although exploratory testing has emerged as a powerful test approach within regulated industries, an audit is the impact point where exploratory testing and regulatory worlds collide. Griffin Jones describes a heuristic model—Congruence, Honesty, Competence, Appropriate Process Model, Willingness, Control, and Evidence—his team used to survive an audit. You can use this model to prepare for an audit or to baseline your current practices for an improvement program. Griffin highlights the common misconceptions and traps to avoid with exploratory testing in your regulated industry. Avoid mutual misunderstandings that can trigger episodes of incongruous behavior and an unsuccessful audit. Learn how to maintain your composure during a stressful audit and leave with valuable heuristics to help you organize and present your exploratory testing results with confidence.
Software glitch causes prescription error across R.I.
http://www.cmio.net/index.php?option=com_articles&view=article&id=30336
Software glitch causes prescription error across R.I.
Many patients? Many patients are not overdosing?
Doesn't that mean that some patients are/were overdosing?
Software glitch causes prescription error across R.I.
The software issue led to some discharged patients, who should have received a prescription for timed-release form of their medication, possibly receiving a prescription or instructions for the regular form. Timed-release medications are generally taken once a day, whereas the regular formulation provides the same effective dose of the medication, but the medication is taken multiple times over the course of a day.
The issue does not affect emergency room patients or outpatients.
Lifespan contacted 2,000 patients affected by this issue to ensure they receive the correct form of their medications. Many of the patients were already taking the correct medication, according to the provider.
Many patients? Many patients are not overdosing?
Doesn't that mean that some patients are/were overdosing?
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