From: Brian W. Spolarich (bspolarichnephrostherapeutics.com)
Date: Tue Apr 08 2003 - 13:21:41 CDT

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  While all of this is true, the question of "closed systems" versus "open systems" doesn't really address the question of application validation vis a vis system patches and updates.
 
  Regardless of how you define your system (open or closed), if the applications or processes you're conducting using those systems fall under regulatory scope, you need to have evidence that you're keeping careful controls and change management processes and documentation around changes to those systems, including operating system patches and any other software installations. The question of electronic signatures as discussed in 21 CFR Part 11 applies to electronic records of any sort, particularly those involved in the manufacture, distribution, quality, safety, etc. of those products regulated by the FDA.
 
 In addition, here is some diversity of opinion among those in the community of people who need to pay attention to these regulations as to what "open" versus "closed" systems are. Some folks seem to think open systems includes any system which is delivered end-to-end over one or more components that are not directly controlled and managed by the regulated organization. This would include anything that happens over the Internet (arguably). Other folks tend to be a bit more pragmatic about such matters and treat the pipe as a pipe.
 
  I don't think the FDA has issued warning letters specifically about such issues, and I don't recall seeing any definitive guidance on this particular question. My point here is that if you are entering the brave world of systems validation for FDA regulatory compliance you need to think through the issues carefully, document everything you do, and make sure that you have a good, well-reasoned argument regarding the choices you have made. Your FDA inspector or examiner may ultimately disagree with you and recommend that you change your practices, but that's far different from not having considered them at all. With the addition of many new inspectors at the FDA they may start paying attention to the IT side of things in more detail.
 
  If you're new to this stuff I would recommend the Institite of Validation Technology (IVT) publications and conferences. I found their training conferences very useful and well-organized. You can find them on the web at http://www.ivthome.com/. You can see warning letters issued by the FDA at http://www.fdawarningletter.com/.
 
  Best regards,
 
  -bws

        -----Original Message-----
        From: Hibbs, Ted [mailto:THibbs5prime.com]
        Sent: Tue 4/8/2003 1:38 PM
        To: focus-mssecurityfocus.com
        Cc:
        Subject: RE: SUS server
        
        

        I just gotta jump in on this since we are working to get under 21 CFR
        Part 11
        
        Hold on, here comes two paragraphs of the legal stuff... ;^(
        
        The regulation states, "Persons who use closed systems to create,
        modify, maintain, or transmit electronic records shall employ procedures
        and controls designed to ensure the authenticity, integrity, and, where
        appropriate, the confidentiality of electronic records, ... Such
        procedures and controls shall include the following:... (a) Validation
        of systems to ensure accuracy, reliability, consistent intended
        performance, and the ability to discern invalid or altered records....
        (d) Limiting system access to authorized individuals." A Closed System
        is defined as, "Closed System means an environment in which system
        access is controlled by persons who are responsible for the content of
        electronic records that are on the system." I can agree that, if 2K SP3
        licensing grants M$ access to the machine, the machine cannot be
        considered a closed system under this part of the rule.
        
        However, there are also provisions for an "Open System" under this rule.
        An "Open System means an environment in which system access is not
        controlled by persons who are responsible for the content of electronic
        records that are on the system." In an Open System, "Persons who use
        open systems to create, modify, maintain, or transmit electronic records
        shall employ procedures designed to ensure the authenticity, integrety,
        and, as appropriate, the confidentiality of electronic records from the
        point of their ceration to the point of their receipt. ...additional
        measures such as document encryption and use of appropriate digital
        signature standards to ensure ... Authentickty, integrety, and
        confidentiality." So there are options to keep the system under 21 CFR
        Part 11 and still grant access to the system. The rule appears to
        address databases more than complete systems, but their wording cannot
        limit the access to just the databases.
        
        So as I see it, you have two options: Keep the system as a closed
        system by closing the link between your system and M$ either logically
        as in routing tables and firewalls, or physically as in no wire from
        your closed system to any external system. Or define the system as an
        open system and employ encryption and digital signatures so that anyone
        who can get into the system cannot read or modify the encrypted files.
        
        Mind you, I don't have access to the most current FDA rulings on this,
        but will attempt to get additional information as to whether they have
        addressed this question.
        
        Ted
        

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