Commercial gage scheduling software package that can store multiple PPM histories

S

sgiorgi

#1
Scheduling software

I am looking for a commercial scheduling software package that can store multiple PPM histories for each instrument entered into the database - service/calibration/PAT history etc.

The package also has to be validated and conform to FDA requirements for electronic records and signatures - we are being audited by them next year.

The only software I have found so far that meets these requirements is from Blue Mountain Resources. If anyone knows of any more I would be grateful to here from them.

Thanks in advance.
 
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Jerry Eldred

Forum Moderator
Super Moderator
#2
I can not (will not) recommend any software in this format. I have been doing some research into calibration software recently, and so I have a few companies names:

- Blue Mountain Software(www.coolblue.com)
- Norfox (makes Labmate, Calmate, VanMate(www.norfox.com)
- Industrial Process Measurement, Inc.(www.instrumentation2000.com)
- Cybermetrics Corporation(www.cybermetrics.net)
- PMI Software Ltd.(www.pmisoftware.com)
- Diversified Data Systems Inc.((www.dds-inc.com)
- Intercal Inc.(www.intercalinc.com)
- SureCal Automatic Calibration Software(www.surecal.com)

As this is all the vendors I know about, I am being as impartial as I can. I won't recommend or make any positive or negative judgments on any of them. There are also some general metrology websites that have links pages listing various software packages out there.
 
S

sgiorgi

#3
Thanks for your help. I have also found the following www.maintenanceresources.com which has lots of links to suppliers of cmms packages.

I have one more question which I would be greatful for you opinion on.

Out of the packages I have looked at almost all have been developed in line with ISOs tickit and/or have some kind of validation documentation/software to go with it.

Only a couple (Blue Mountain is one) state that they comply with FDA requirements (Electronic Signitures & Records etc.)

This is the crunch question.

As I only want to store locations, cal dates & frequencies so that I can recall items when they are next due for calibration (all calibration data is kept in paper form on certificates) do I need to worry?

We use Kaye KL dataloggers, LTRs and IRTD probes when mapping autoclaves and in this case I know we need to comply (and Kaye do) as the raw data collected is in electronic form.

But as we are not planning to store our calibration data in electronic form will we come up with a problem if we do not choose a package that complies with these requirements (we are currently on schedule to be audited by the FDA next year.

Many thanks.
 

Jerry Eldred

Forum Moderator
Super Moderator
#4
As FDA requirements is not one of my areas of expertise, I will have to defer comment on what it takes for compliance.

I can say that at least in my experiences and knowledge, you can theoretically operate a lab without any software package at all. There is no where in any standard I am familiar with that requires use of a software package. Again, I am not familiar with FDA requirements.

What you are responsible for is maintaining appropriate control of your records, procedures, etc. (many other things). I would recommend reading through line by line and doing a gap analysis. What I typically do is put the standard I need to comply with into spreadsheet format. Then next to each paragraph, what actions need to be taken to comply. If you're not sure what you need to do to comply, a thorough, detailed reading of the standard will at least help understand exactly what needs to be done.
 

Jerry Eldred

Forum Moderator
Super Moderator
#5
CAL SCHEDULING SOFTWARE---

Some of the below is a re-run, but I received this
in a listserv email I subscribe to. It may give a
little more comprehensive listing of what is available out there. No reommendation or editorializations, only as complete a list as I can find.

ProGAGE1 www.aqsinc.com
GAGEtrak www.cybermetrics.net
LabMate
Met-Track www.fluke.com
Cal Manager www.coolblue.com
Gage Calibration www.jblsys.com
QCPRO Gage Control www.pister.com
PowerWay Gage Mgr www.powerway.com
Gage Calibration 2.0 www.starrett.com
QA Calibrate 2.0 www.qualityamerica.com
InfinityQS GTS www.qualitronsystems.com
GAGEpack 2000 www.pqsystems.com
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#6
> What I typically do is put the standard I need to comply
> with into spreadsheet format. Then next to each paragraph,
> what actions need to be taken to comply.

As most of you know, I work with companies in complying with standards. I agree with this methodology any time you have to comply with one or more standards. I have used it for many years and it has always been 'good' to me. If you take a look through http://Elsmar.com/Imp/ you will see it used. If you would like to see an 'early' example where multiple requirements (ISO 9001, QS9000 and VDA 6) were addressed, see QS-Req.pdf in the pdf_files directory ( http://Elsmar.com/pdf_files/ )

The spreadsheet 'listing' from the specification is sorta like a check list. It's all there - Now, can you point to the requirements line item by line item and follow through by putting how/where you comply in another column. However, you must have some understanding of the requirement you must meet.
 

Bubba

Involved In Discussions
#7
I work in a company that is regulated by the FDA and we are currently using the Blue Mountain software for our calibration scheduling. The features built into this particular software do make it rather easy to comply with 21 CFR part 11 for electronic signatures and a software validation protocol is available (for an extra charge) to help meet FDA requirements for validation.

However, if you are not keeping electronic records of your calibration activities, electronic signatures do not really apply. The FDA rules for electronic signatures were created to give technologically advanced companies the option of making electronic records equivalent to paper records and electronic signatures equivalent to handwritten signatures.

If, as you stated, you are only using the software to recall due dates, and not for record keeping, Blue Mountain may be overkill. There are other software packages out there that are a lot cheaper and will do the job just fine. It's possible that even a basic database program such as Microsoft Excel or Access would meet your needs.

I hope this helps.
 
A

Afifuddin

#8
Its good to get your thing organize but if you are fimiliar with Microsoft Access, you can create your own database unless you need to connect to some of your sophisticated equipment via rs232 or etc. which giving the calibration result the you might have to purchase that software.
 
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