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Thread: eSignature Module & Local Data Logging Niagara 4

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    eSignature Module & Local Data Logging Niagara 4

    We have a project that we are about to be awarded that requires validated data to conform with FDA regulations. On this job, we are installing a Niagara 4 Supervisor loaded with the eSignature module in order to provide validated data for their electronic records. One of the requirements on this job is to provide temperature, humidity, and differential pressure sensors that can be connected to a local data logger that then can be connected to the Supervisor server. I have been working with Vaisala on my sensor selections, but they claim that their data loggers cannot be directly connected into a BAS. This customer has to have data 24/7 (even if the server goes down or loses connectivity). Once connectivity is restored, the data from the data logger needs to be pushed up to the Supervisor server. Initially I thought about a JACE with IO running the eSignature module. I just don't know if a JACE truly qualifies as a FDA regulated data logger.

    Has anyone dealt with jobs like this before? If so, what data logger options have you seen? Is there a data logger on the market that has BACnet IP communication?

    Any feedback on this is appreciated. This is unfamiliar territory for us.
    J. King

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    Should be able to use a standard controller reporting to Tridium in many cases. Haven't used Tridium in this app yet, but I assuming the esig license is really just adding another layer of security on the logs and auditing. Far as the total total system meeting the regulations, esig stuff is only part of it. End user procedures and how everything is put together is just as big of deal.

    They might want all the wiring of their critical points to be within secured areas. The super/tbox will likely have to be in an area that only a handful of people can access and under CCTV. Everything can go to crap if someone can piss around with the equipment. That's where the procedures come in. Some of the hassle is pushed on other systems/procedures to make sure nothing can be tampered without notice. Usually the customer will have someone that is ensuring all the FDA boxes are ticked off before turnover. Finding them early is a good idea if the project documents are crap.
    Propagating the formula. http://www.noagendashow.com/

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    Italmost sounds like 'if the people you are installing for like it, then it is good' to a certain extent.
    I like the logging at the JACE idea. Then it lushes up when the server comes back.
    Hmmmm....smells like numbatwo to me.

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    CAS Data Loggers from Thermo Fisher Scientific, appear to have the ability to export data via modbus slave as well as paperless chart recorders that can do the same. I have never used these though but may be worth a look. I visited a pharm site that uses iVu to log their data from OPN controllers, which I was surprised that met their requirements, but cant say anything in regards to a JACE. At this site I also found that every temp sensor has the same calibration offset, with a cert sticker attached, so it makes you wonder about compliance sometimes.

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    Quote Originally Posted by hvac69 View Post
    I visited a pharm site that uses iVu to log their data from OPN controllers, which I was surprised that met their requirements
    You don't need external loggers. They could be a bigger hassle to deal with as they would have to meet the handful of FDA requirements around log tampering, auditing, etc. Not to mention if you lose comms with these, can you sync back up the logs in Tridium? Standard controllers feeding back to a database the meets CFR title 21 requirements should suffice.
    Propagating the formula. http://www.noagendashow.com/

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    Quote Originally Posted by numbawunfela View Post
    Italmost sounds like 'if the people you are installing for like it, then it is good' to a certain extent.
    I like the logging at the JACE idea. Then it lushes up when the server comes back.
    Yeah, that is exactly what I was thinking. Is there a way to have the Supervisor pull the history data from the JACE automatically once network connectivity has been re-established? Or should I just setup the validated points to import into the Supervisor more frequently (rather than once a day)?

    The big thing I was wondering is whether the data down in the JACE needs to be considered "validated by eSignature" or if only the data in the Supervisor needs to be "validated by eSignature"? In once sense... I feel that they will only be interacting with the validated data the Supervisor under all normal circumstances. If the network would go down to the JACE, and return to normal after X amount of time, the data pushed back up to the Supervisor would still be considered validated by eSignature once it reached the Supervisor level. Would having it validated at the JACE level be a FDA regulation or would it really be up to the customer? The eSignature module is VERY expensive, so having it on every JACE and the Supervisor will get pretty pricey. Thanks for your feedback.
    J. King

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    Quote Originally Posted by orion242 View Post
    Should be able to use a standard controller reporting to Tridium in many cases. Haven't used Tridium in this app yet, but I assuming the esig license is really just adding another layer of security on the logs and auditing. Far as the total total system meeting the regulations, esig stuff is only part of it. End user procedures and how everything is put together is just as big of deal.

    They might want all the wiring of their critical points to be within secured areas. The super/tbox will likely have to be in an area that only a handful of people can access and under CCTV. Everything can go to crap if someone can piss around with the equipment. That's where the procedures come in. Some of the hassle is pushed on other systems/procedures to make sure nothing can be tampered without notice. Usually the customer will have someone that is ensuring all the FDA boxes are ticked off before turnover. Finding them early is a good idea if the project documents are crap.
    Thanks for all of your feedback on this. These are all very good points and topics of discussion that I need to have with the customer.
    J. King

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    Quote Originally Posted by apprentice3 View Post
    Thanks for all of your feedback on this. These are all very good points and topics of discussion that I need to have with the customer.
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    I was reviewing the specification sheets for eSignature and found that there is a deployment that has JACEs running eSignature under a Supervisor. If I am looking at option #2, then I assume that I don't need to license the Supervisor for eSignature? This customer told me that the only points that need to be validated by eSignature is temperature, relative humidity, and differential pressure. My thought was, if I went with JACE controllers with IO, then I could just wire all of the validated points to the JACE controllers and provide local trending. Option #2 sounds like you are validating down at the JACE level and pushing validated data directly up to the Supervisor. I noticed that the eSignature module changes the way the certain ACTION slots look in Niagara. I assume the overall eSignature ACTION slots will automatically get pushed up to the Supervisor? I just want to make sure I don't need to license the JACEs and the Supervisor on this project.

    Any feedback on this is appreciated!
    J. King

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    Never used Tridium for this, but I'm betting you need it on both since some could fool around with the logs in the Jace potentially. Another reason to just use whatever controller in the field with I/O. If the only way they can muck with that controller is via the programming tools they don't have, it should be a non-issue.

    Quote Originally Posted by apprentice3 View Post
    Initially I thought about a JACE with IO running the eSignature module. I just don't know if a JACE truly qualifies as a FDA regulated data logger.
    If it has the esig license it should meet the requirements for the FDA. Can you get the storage they require is another question down that path.
    Propagating the formula. http://www.noagendashow.com/

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    Quote Originally Posted by apprentice3 View Post
    Is there a way to have the Supervisor pull the history data from the JACE automatically once network connectivity has been re-established?
    Would having it validated at the JACE level be a FDA regulation or would it really be up to the customer? The eSignature module is VERY expensive, so having it on every JACE and the Supervisor will get pretty pricey. Thanks for your feedback.
    For the first part, yes. If your JACE holds 3 days of trending, and the server asks for that trending daily, if the network goes down for 2 days, the server will get that trending for the last 2+ days in a fat lump when he asks for it on the 3rd day. So trend non essential stuff for local storage of 2 or 3 days, and the critical stuff for a week or more. Then you have that much time to fix stuff before you start to lose data. If the network is down for 4 days and the JACE has 3 days worth of data, then the JACE will roll over the older data, and you will lose a day of stuff from 4 days ago.
    It looks like the little 3 path diagram came from Niagara's sales sheet. I recognize the formatting. So ask Niagara if path 2 needs to have licenses at the JACE and sup. It is their sales brochure, they would know.
    Worst case is you give a submittal to the customer telling them in writing it will be at the JACE. They approve it, you install it. Then some regulator punches them and says it needs to be at the Sup too. So you charge them to add it. You submitted it, and they approved it.
    Last edited by numbawunfela; 05-01-2021 at 11:29 PM.
    Hmmmm....smells like numbatwo to me.

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    Quote Originally Posted by orion242 View Post
    Never used Tridium for this, but I'm betting you need it on both since some could fool around with the logs in the Jace potentially. Another reason to just use whatever controller in the field with I/O. If the only way they can muck with that controller is via the programming tools they don't have, it should be a non-issue.
    As I have read through the documentation, it looks like when you have a JACE installation under a Supervisor, you need to have the eSignature modules on the JACEs. It claims that you can utilize a regular Supervisor, since all of the data is being validated by eSignature down at the JACE level. I am assuming this means that all of the point data coming up into the Supervisor must inherit the eSignature properties from the subordinate JACEs?

    So for this application you would utilize a field controller with IO over using direct IO-R on the JACE? I see what you're saying about the programming tools... With JACE IO they could technically get down into the programming if they wanted to. However, as I have read through the eSignature documentation it has a whole bunch of stuff about categories, roles, authorization levels, levels of approval, having to provide reason before a change, etc. Typically, I prefer a field controller with IO over a JACE any day. However, in this application they have asked us to install extremely expensive/ high quality Vaisala sensors directly to a data logger to eliminate multiple points of communication failure. I felt that a JACE with IO would be the closest thing to that.

    Quote Originally Posted by orion242 View Post
    If it has the esig license it should meet the requirements for the FDA. Can you get the storage they require is another question down that path.
    Yep I already asked them the question about storage yesterday afternoon. I am hoping they are reasonable with this, since under normal circumstances, we will be offloading data onto the Supervisor. Thanks for all of your feedback.
    J. King

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    Quote Originally Posted by numbawunfela View Post
    For the first part, yes. If your JACE holds 3 days of trending, and the server asks for that trending daily, if the network goes down for 2 days, the server will get that trending for the last 2+ days in a fat lump when he asks for it on the 3rd day. So trend non essential stuff for local storage of 2 or 3 days, and the critical stuff for a week or more. Then you have that much time to fix stuff before you start to lose data. If the network is down for 4 days and the JACE has 3 days worth of data, then the JACE will roll over the older data, and you will lose a day of stuff from 4 days ago.
    It looks like the little 3 path diagram came from Niagara's sales sheet. I recognize the formatting. So ask Niagara if path 2 needs to have licenses at the JACE and sup. It is their sales brochure, they would know.
    Worst case is you give a submittal to the customer telling them in writing it will be at the JACE. They approve it, you install it. Then some regulator punches them and says it needs to be at the Sup too. So you charge them to add it. You submitted it, and they approved it.
    Yeah, I sent some questions in regards to OPTION 2 to our support channel. I found some additional documentation that makes me think that if you have it on the JACEs, then you don't need it on the Supervisor. However, I definitely know where you're coming from. I would like to include it at both levels to be safe, but the price tag on this module is very HIGH. They even charge you for support on the driver/ module. If you want support on the eSignature Module, you have to purchase the support from Tridium. The support is only valid for a maximum of 8 hours. It has to be used within 90 days of purchasing the support. They also offer a 2.5 hour virtual training session on the module as well. That also costs quite a bit of money.. Thanks for your feedback.

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    J. King

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