{"thread":{"id":"36927","subject":"ISO 13485","startedAt":"2014-06-16T15:14:01Z","lastAt":"2014-06-17T20:03:59Z","messageCount":5,"participants":["agi","Jason Pyeron","Philip Oakley"],"isPatch":false,"patchVersion":null,"patchTotal":null},"messages":[{"id":"244251","messageId":"539F09B9.3050200@omixon.com","threadId":"36927","inReplyTo":null,"subject":"ISO 13485","fromName":"agi","fromEmail":"agnes.pasztor@omixon.com","sentAt":"2014-06-16T15:14:01Z","receivedAt":"2014-06-16T15:14:01Z","isPatch":false,"sender":{"key":"agnes.pasztor@omixon.com","avatar":null},"body":"Hello,\n\nI would like to ask a question about GIT v. 1.7\n\nIs it compatible with ISO 13485 (quality management system)? Can it be \nused for developing a medical diagnostic software?\n\nThank you!\n\nKind Regards,\nAgnes Pasztor\n"},{"id":"244252","messageId":"9738CF1519014998B579C405EB4FA22B@black","threadId":"36927","inReplyTo":"539F09B9.3050200@omixon.com","subject":"RE: ISO 13485","fromName":"Jason Pyeron","fromEmail":"jpyeron@pdinc.us","sentAt":"2014-06-16T15:20:53Z","receivedAt":"2014-06-16T15:20:53Z","isPatch":false,"sender":{"key":"jpyeron@pdinc.us","avatar":"https://gravatar.com/avatar/c2e53452caa53d940768a1ffc9cf76196d851b9b534b7a39cd39852a70a0508f?d=mp&s=160"},"body":"> -----Original Message-----\n> From: agi\n> Sent: Monday, June 16, 2014 11:14\n> \n> Hello,\n> \n> I would like to ask a question about GIT v. 1.7\n> \n> Is it compatible with ISO 13485 (quality management system)? \n> Can it be \n> used for developing a medical diagnostic software?\n\nYes.\n\nNow, do you have a specific question about how to use Git in your QA process?\n\n--\n-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-\n-                                                               -\n- Jason Pyeron                      PD Inc. http://www.pdinc.us -\n- Principal Consultant              10 West 24th Street #100    -\n- +1 (443) 269-1555 x333            Baltimore, Maryland 21218   -\n-                                                               -\n-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-\nThis message is copyright PD Inc, subject to license 20080407P00.\n\n \n"},{"id":"244395","messageId":"53A05766.7060502@omixon.com","threadId":"36927","inReplyTo":"9738CF1519014998B579C405EB4FA22B@black","subject":"Re: ISO 13485","fromName":"agi","fromEmail":"agnes.pasztor@omixon.com","sentAt":"2014-06-17T14:57:42Z","receivedAt":"2014-06-17T14:57:42Z","isPatch":false,"sender":{"key":"agnes.pasztor@omixon.com","avatar":null},"body":"Hi Jason,\n\nThanks for the speedy reply. We are in the process of trying to make our \nsoftware product ISO13485 compatible and we are assessing all systems \nthat we use.\nDo you have a validation document for git that could provide information \non how to use it in order to comply with ISO legislations?\nAny additional information or material you can think of is more than \nwelcome.\n\nThanks in advance for your help!\n\n\nBest Regards,\nAgnes Pasztor\n\nSenior Test Engineer\nOmixon Biocomputing Ltd.\n\n\nOn 06/16/2014 05:20 PM, Jason Pyeron wrote:\n>> -----Original Message-----\n>> From: agi\n>> Sent: Monday, June 16, 2014 11:14\n>>\n>> Hello,\n>>\n>> I would like to ask a question about GIT v. 1.7\n>>\n>> Is it compatible with ISO 13485 (quality management system)?\n>> Can it be\n>> used for developing a medical diagnostic software?\n> Yes.\n>\n> Now, do you have a specific question about how to use Git in your QA process?\n>\n> --\n> -=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-\n> -                                                               -\n> - Jason Pyeron                      PD Inc. http://www.pdinc.us -\n> - Principal Consultant              10 West 24th Street #100    -\n> - +1 (443) 269-1555 x333            Baltimore, Maryland 21218   -\n> -                                                               -\n> -=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-\n> This message is copyright PD Inc, subject to license 20080407P00.\n>\n>   \n>\n"},{"id":"244398","messageId":"0368137BF4DA4E798A17D74DAFE30FEF@black","threadId":"36927","inReplyTo":"53A05766.7060502@omixon.com","subject":"RE: ISO 13485","fromName":"Jason Pyeron","fromEmail":"jpyeron@pdinc.us","sentAt":"2014-06-17T15:30:17Z","receivedAt":"2014-06-17T15:30:17Z","isPatch":false,"sender":{"key":"jpyeron@pdinc.us","avatar":"https://gravatar.com/avatar/c2e53452caa53d940768a1ffc9cf76196d851b9b534b7a39cd39852a70a0508f?d=mp&s=160"},"body":"> -----Original Message-----\n> From: agi\n> Sent: Tuesday, June 17, 2014 10:58\n> \n> Hi Jason,\n> \n> Thanks for the speedy reply. We are in the process of trying \n> to make our \n> software product ISO13485 compatible and we are assessing all systems \n> that we use.\n> Do you have a validation document for git that could provide \n> information \n> on how to use it in order to comply with ISO legislations?\n\nThat would be customized to your QA process. A generalized document would be too\nvague. I am sure any process consultant could draft that up for you.\n(disclaimer: I have been paid to do things like this before)\n\nMaybe you could start by searching with things like\nhttps://www.google.com/search?q=using+QA+with+Git or contacting Atlassian about\ntheir QA product suite integration with Git.\n\nMaybe you could find a process consultant to do it cheaper if you release it out\nto the FOSS community?\n\nThe \"nice\" (read as less effort) thing about ISO 13485 is it does not have a\ncontinual improvement requirement so as long as \"defects\" are detected and\nremediated you are good. Please note git does not detect defects, git does not\nremediate defects. What git does is ensure the approved artifact is unchanged in\nany attribute to maintain the exact level of quality from first inspection of\nthat artifact for an unlimited amount of iterations. Git has built in \"digital\nsignatures\" on the artifacts stored in its repository.\n\n> Any additional information or material you can think of is more than \n> welcome.\n> \n> Thanks in advance for your help!\n> \n> \n> Best Regards,\n> Agnes Pasztor\n> \n> Senior Test Engineer\n> Omixon Biocomputing Ltd.\n> \n> \n> On 06/16/2014 05:20 PM, Jason Pyeron wrote:\n> >> -----Original Message-----\n> >> From: agi\n> >> Sent: Monday, June 16, 2014 11:14\n> >>\n> >> Hello,\n> >>\n> >> I would like to ask a question about GIT v. 1.7\n> >>\n> >> Is it compatible with ISO 13485 (quality management system)?\n> >> Can it be\n> >> used for developing a medical diagnostic software?\n> > Yes.\n> >\n> > Now, do you have a specific question about how to use Git \n> in your QA process?\n\n--\n-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-\n-                                                               -\n- Jason Pyeron                      PD Inc. http://www.pdinc.us -\n- Principal Consultant              10 West 24th Street #100    -\n- +1 (443) 269-1555 x333            Baltimore, Maryland 21218   -\n-                                                               -\n-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-\nThis message is copyright PD Inc, subject to license 20080407P00.\n"},{"id":"244479","messageId":"0C346DC34D5E4A4F92F12D0956DBA4BB@PhilipOakley","threadId":"36927","inReplyTo":"0368137BF4DA4E798A17D74DAFE30FEF@black","subject":"Re: ISO 13485","fromName":"Philip Oakley","fromEmail":"philipoakley@iee.org","sentAt":"2014-06-17T20:03:59Z","receivedAt":"2014-06-17T20:03:59Z","isPatch":false,"sender":{"key":"philipoakley@iee.email","avatar":"https://avatars.githubusercontent.com/u/914343?v=4"},"body":"Agnes,\n\nI'd like to re-emphasise Jason's excellent comments, below:\n\nFrom: \"Jason Pyeron\" <jpyeron@pdinc.us>\n>> From: agi\n>> Sent: Tuesday, June 17, 2014 10:58\n>>\n>> Hi Jason,\n>>\n>> Thanks for the speedy reply. We are in the process of trying\n>> to make our\n>> software product ISO13485 compatible and we are assessing all systems\n>> that we use.\n>> Do you have a validation document for git that could provide\n>> information\n>> on how to use it in order to comply with ISO legislations?\n>\n> That would be customized to your QA process. A generalized document \n> would be too\n> vague. I am sure any process consultant could draft that up for you.\n> (disclaimer: I have been paid to do things like this before)\n>\n> Maybe you could start by searching with things like\n> https://www.google.com/search?q=using+QA+with+Git or contacting \n> Atlassian about\n> their QA product suite integration with Git.\n>\n> Maybe you could find a process consultant to do it cheaper if you \n> release it out\n> to the FOSS community?\n>\n> The \"nice\" (read as less effort) thing about ISO 13485 is it:\n> *     does not have a continual improvement requirement\n>           so as long as \"defects\" are detected and\n>             remediated you are good.\nThat detection is part of your wider QA system.\n\n> Please note:\n> *     git does not detect defects,\n> *     git does not remediate defects.\n\nThat's not the job of Git (or any version control system and it's \nrepository).\n\n> What git does is:\n> *     ensure the approved artifact is unchanged in any attribute\n>        to maintain the exact level of quality from first inspection\n>       of that artifact for an unlimited amount of iterations.\n> *    Git has built in \"digital signatures\" on the artifacts stored in \n> its repository.\n>\nThese are the big points. The fact that everything is fully 'signed' by \nthe sha1 and can't be altered is the guarantee that runs all the way up \nand down the git commit heirachy. If you have the same sha1 you have the \nsame (identical, byte for byte) history - fsck will check all the way \ndown to the very first entry.\n\nYou can also tag specific points as formal releases to simplify the \nassociation of a nice name to a specific sha1. The releaser can even gpg \nsign it.\n\nYou still need to ensure you take formal backups and archives in the \nusual way, though Git gives you extra security because of the implicit \nduplication among developers, readers and contributors.\n\nAs an aside, branching[1] allows developers to still tidy up their work \n(rebase etc) before it is accepted as part of the release software. That \nwork still has its sha1 signatures, whether for the prior 'ugly' work or \nnew sha1 signatures for the 'tidy' work that is / hopes to be \nincorporated into the release.\n\n>> Any additional information or material you can think of is more than\n>> welcome.\n>>\n>> Thanks in advance for your help!\n>>\n>>\n>> Best Regards,\n>> Agnes Pasztor\n>>\n>> Senior Test Engineer\n>> Omixon Biocomputing Ltd.\n>>\n>>\n>> On 06/16/2014 05:20 PM, Jason Pyeron wrote:\n>> >> -----Original Message-----\n>> >> From: agi\n>> >> Sent: Monday, June 16, 2014 11:14\n>> >>\n>> >> Hello,\n>> >>\n>> >> I would like to ask a question about GIT v. 1.7\n>> >>\n>> >> Is it compatible with ISO 13485 (quality management system)?\n>> >> Can it be\n>> >> used for developing a medical diagnostic software?\n>> > Yes.\n>> >\n>> > Now, do you have a specific question about how to use Git\n>> in your QA process?\n>\n> --\n> -=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-\n> -                                                               -\n> - Jason Pyeron                      PD Inc. http://www.pdinc.us -\n> - Principal Consultant              10 West 24th Street #100    -\n> - +1 (443) 269-1555 x333            Baltimore, Maryland 21218   -\n> -                                                               -\n> -=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-\n> This message is copyright PD Inc, subject to license 20080407P00.\n>\n[1] Branching is part of the strength of Git's \"DAG\" (Directed Acyclic \nGraph) structure.\n\nPhilip. \n"}]}