Hi everyone,
Our company is governed by FDA and the new ISO13485. I have, what I believe is a good system for calibration, but I have a question regarding calibration software. Recently, our sister company got hit with a 483 from the FDA for storing calibration scheduling records in a system called MP2 software. Since MP2 software is not part11 compliant, they got a 483 from the FDA. At my site, we are OK because we use Calibration Manager software.

I currently use Calibration Manager by Blue Mountain for my calibration needs. I've never had an issue with the software, and we have always passed every audit with no questions regarding the software that we use. Since getting a 483, our sister company would like to move the entire organization to using Maximo software package, especially for Maintenance. I've already seen a web demo of the software for calibration, and on the screen it looks okay, but they don't have a working demo to actually try the software out. The Maximo software has several plug-ins, and one of them is the calibration module.

Anyone have any comments, good or bad, on Maximo software for use in Calibration, especially if you are in a Pharmaceutical environment? Before I decide to jump on the band wagon, I want to make sure that this software will not only meet our needs, but be able to pass FDA, BSI, and other auditing agencies like Calibration Manager.
http://www.mro.com/

Hi everyone,
Our company is governed by FDA and the new ISO13485. I have, what I believe is a good system for calibration, but I have a question regarding calibration software. Recently, our sister company got hit with a 483 from the FDA for storing calibration scheduling records in a system called MP2 software. Since MP2 software is not part11 compliant, they got a 483 from the FDA. At my site, we are OK because we use Calibration Manager software.

I currently use Calibration Manager by Blue Mountain for my calibration needs. I've never had an issue with the software, and we have always passed every audit with no questions regarding the software that we use. Since getting a 483, our sister company would like to move the entire organization to using Maximo software package, especially for Maintenance. I've already seen a web demo of the software for calibration, and on the screen it looks okay, but they don't have a working demo to actually try the software out. The Maximo software has several plug-ins, and one of them is the calibration module.

Anyone have any comments, good or bad, on Maximo software for use in Calibration, especially if you are in a Pharmaceutical environment? Before I decide to jump on the band wagon, I want to make sure that this software will not only meet our needs, but be able to pass FDA, BSI, and other auditing agencies like Calibration Manager.
http://www.mro.com/I always assume, when it comes to part 11 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11), that if they don't promote the product as Part 11 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11) compliant, that it isn't. If I were you, I would ask the supplier if the software is part 11 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11) compliant. If they don't know what you are talking about, move on.

Thanks Al. The software is part11 compliant, according to the sales person that demoed the software.