Monthly Archive for November, 2011

Validation of Off-The-Shelf Software Development Tools

A reader asked me about OTS software tool validation. He says:

It seems to me that the editor and any other tool used to create the software is exactly that, a productivity tool. The end result (compiled binary installed on a validated PC configuration) is still going to go through verification and validation, therefore, it seems validating any of the items used to actually create the binary is unnecessary.

Any thoughts or guidance to help me understand this process?

This is a great question and the source of a lot of confusion.

The bottom line is that all third party tools (and libraries) used to construct or test FDA regulated software need to be validated.

You may think validating a compiler is unnecessary, but the FDA says otherwise — section 6.3 of the FDA Guidance on General Principles of Software Validation discussion includes “off-the-shelf software development tools, such as software compilers, linkers, editors, and operating systems.”

The form of the required documentation is detailed in the Off-The-Shelf Software Use in Medical Devices guidance document.  Section 2.1 has the questions that the OTS software BASIC DOCUMENTATION needs to answer:

  1. What is it?
  2. What are the Computer System Specifications for the OTS Software?
  3. How will you assure appropriate actions are taken by the End User?
  4. What does the OTS Software do?
  5. How do you know it works?
  6. How will you keep track of (control) the OTS Software?
For most products (again, OTS tools and libraries, including open source products) this documentation is not as onerous as you might think.  #5 is where you apply the intended use validation to the specific product. I have done this for many products: Visual Studio,  Subversion/TortoiseSVN, NUnit, Log4Net, etc.  You also need to validate custom developed testing tools and fixtures.
Like it or not, this is the reality of developing FDA regulated software.

Brain Wave Monitoring Through the Extremities

The recent Time Magazine article Thought Control (subscription required) describes what is essentially another brain-computer interface.  What’s novel about this device is that the EEG signal is monitored from dry electrodes on the arm or leg. The BodyWave® Brain Wave Monitoring (pdf) system developed by Freer Logic claims to allow measurement of brain wave activity away from the head:

BodyWave simply views brain energy as a field, collects the field energy as if the brain were a radio tower broadcasting from the brain and through the body.

For the purposes of teaching “stress control, increase attention, and facilitate peak mental performance”, this may well be an adequate method.  Not having to wear the more traditional EEG head gear is certainly an advantage.  Providing reliable control of computer interaction tasks via either “mind reading” method is not likely to happen any time soon (see Turning the Mind into a Joystick).



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