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I had an interesting talk over lunch with a guy developing for nuclear power plants. He likes to introduce Scrum or at least some elements. The big question he has: Are there already known examples of Software for systems under safety restrictions (nuclear power plants, medical devices, observation devices, ...) developed with Scrum? Do you have any links, documents?

I've used Scrum in 2005 in a software project creating forensic software. Since, it possibly could harm a person by sending the wrong person to prison it had to be FDA compliant.
This was in 2005 when FDA was still more waterfall driven, nevertheless we had been able to be agile and to comply to all the laws. In early 2006 the FDA actually changed some laws and made it easier to be agile. They realized that software development is a different beast then mass producing medication.

Siemens medical does a lot of Scrum, the FBI does, the department of defense (USA) does and at least one manufacturer of security devices in Germany does. You should be able to find some documents with Google. There is even a yearly conference in Germany on that: http://www.scrummed.de/

RJ> I've used Scrum in 2005 in a software project creating forensic
RJ> software. Since, it possibly could harm a person by sending
RJ> the wrong person to prison it had to be FDA compliant.

Good morning, Ralph.

I'd be interested in knowing who it was that said the software had to be FDA compliant because it could send the wrong person to prison. In 22 years working in medical devices this is the first I've heard of the FDA getting involved in that sort of thing. What are the relevant regulations? I should read up on it...

Eric Poole
www.rkt-tech.com

Hi Eric,
the software was used to validate genetic sequencers, hybridizer and amplifiers and other devices.

In order for a laboratory to be allowed to submit DNA sequencing results to court it has to be validated. Validated means that it can reliable reproduce the correct result. Often a drop of blood only provides enough material for on sequencing run the result better be right as this could send a person to prison.

The validation is a lengthy time intense process and the software we developed guided the laboratory with step by step instructions. (here the link to the software: http://marketing.appliedbiosystems....to_Landing )

The FDA gets involved whenever a 'device' could put a human being at risk - this rule applied in this case as well. One of the regulations I can remember was CFR21 Part 11.

HTH
Ralph

Good morning, Ralph.

21 CFR 11 is the regulation that deals with electronic record-keeping and electronic signatures. It'd be a real stretch that the FDA would apply it to what you were doing, but it wouldn't be the first time FDA has applied the regulations in hard-to-understand ways :-\.

I can certainly see why your activities need to be validated and run correctly the first time, to conform to the rules of evidence, just don't see why the FDA would necessarily get involved.

Software development for those fields is still in the waterfall model.

http://www.agiledistributed.com/