Dan Waters
dwaters at usinternet.com
Sun Sep 5 19:14:24 CDT 2004
Marty,
I've talked with the FDA and it turns out that they themselves do not
certify anything related to electronic signatures or records. The FDA does
certify an individual company's usage of such software or hardware.
This means that if a company like Alphatrust says that they have been
certified by the FDA, they really mean that they have a customer who has
been certified by the FDA.
The FDA takes this position because what is good for one company may not be
good for another, and the FDA cannot apply a 'blanket' approval for any
particular mechanism. They also don't want to be in the position of
limiting progress in the development of such mechanisms by certifying
something, which then becomes the 'only way to go'.
So - software developers like us need to work with our customer's Regulatory
Managers to find out what the company's requirements actually are. They
will get more difficult as the medical device becomes more complicated or
more important to saving lives or maintaining health.
Dan Waters
-----Original Message-----
From: accessd-bounces at databaseadvisors.com
[mailto:accessd-bounces at databaseadvisors.com] On Behalf Of MartyConnelly
Sent: Sunday, September 05, 2004 5:46 PM
To: Access Developers discussion and problem solving
Subject: Re: [AccessD] Parts and assemblies design
This may give you an idea what is involved, It is essentially an
envelope around the document
with a seal that says it hasn't been modified after signing.
If you are looking for signatures either digital or digitized (mouse or
stylus) that are FDA approved
try things like Pronto from Alphatrust
http://www.alphatrust.com/products/pronto/desktop.asp
Their other products require IE access to a certificate server at around
$250 a month.
Getting your own hardware certificate server certified by FDA may start
to cost you in $10,000 range.
Rocky Smolin - Beach Access Software wrote:
>Dan:
>
>I have no shame.
>
>But I also have no electronic signature feature in the system.
>
> The system evolved when I first released it (1985) based on what the
>customers wanted. So I suppose the first customer who needs electronic
>signatures will get it. But I have no earthly idea how they work. Yet.
>
>Rocky
>
>----- Original Message -----
>From: "Dan Waters" <dwaters at usinternet.com>
>To: "'Access Developers discussion and problem solving'"
><accessd at databaseadvisors.com>
>Sent: Sunday, September 05, 2004 12:38 PM
>Subject: RE: [AccessD] Parts and assemblies design
>
>
>
>
>>Hi Rocky!
>>
>>Yes that was shameless. But good!
>>
>>I was wondering if you address electronic signatures, and if so, what's
>>
>>
>your
>
>
>>approach?
>>
>>Thanks,
>>Dan Waters
>>
>>-----Original Message-----
>>From: accessd-bounces at databaseadvisors.com
>>[mailto:accessd-bounces at databaseadvisors.com] On Behalf Of Rocky Smolin -
>>Beach Access Software
>>Sent: Sunday, September 05, 2004 2:18 PM
>>To: Access Developers discussion and problem solving
>>Cc: Tom Hintz
>>Subject: Re: [AccessD] Parts and assemblies design
>>
>>Eric:
>>
>>Shameless plug for my manufacturing system. You can check it out at
>>www.ezmrp.com
>>
>>It will do the structured bills of material that they need.
>>
>>I just added a Capacity Requirements Planning module to the system which
>>does not yet show on the web site however. In the CRP module you define
>>work centers and then add routings for each assembly - queue time, set up
>>time and unit run time for each operation. Although it's not part of
>>
>>
>their
>
>
>>immediate requirement, as a bonus, the CRP Calculate program will
>>
>>
>calculate
>
>
>>how much of each work center's capacity is being used every day.
>>
>>Once they have that database built, since EZMRP is written in Access, and
>>since the back end is wide open, you could easily write a report in their
>>custom format, although E-Z-MRP does have a traveler report which shows
>>
>>
>the
>
>
>>start date for each operation based on a specific work order, that work
>>order's due date, and the assembly's lead time and, actually, the report
>>
>>
>you
>
>
>>model there looks mostly like an indented bill of materials, which, of
>>course, E-Z-MRP does.
>>
>>Starting with E-Z-MRP's framework might save you a LOT of development
>>
>>
>time.
>
>
>>(BTW, the audit trail that it produces on each inventory transaction, to
>>which you can attach a serial or lot number, also goes along way towards
>>satisfying FDA requirements.)
>>
>>If you're interested after checking the web site, please contact me
>>
>>
>off-line
>
>
>>at bchacc at san.rr.com and I'll give you a system to evaluate. Or call if
>>
>>
>you
>
>
>>want to talk about it - 858-259-4334.
>>
>>HTH
>>
>>Rocky Smolin
>>Beach Access Software
>>http://www.e-z-mrp.com
>>
>>
>>
>>
>>----- Original Message -----
>>From: "Eric Goetz" <EricGoetz at egisystems.com>
>>To: <AccessD at databaseadvisors.com>
>>Sent: Sunday, September 05, 2004 11:32 AM
>>Subject: [AccessD] Parts and assemblies design
>>
>>
>>Hi,
>>
>>
>>
>>I am working on a database to replace some paper forms. I get the
>>feeling I'm starting more "from scratch" than I need to. So I thought
>>I'd ask if anyone knows of any examples of solutions for the following
>>problem.
>>
>>
>>
>>A medical device manufacturer needs to track all the actions performed
>>on each device as it moves through manufacturing to meet FDA
>>requirements. The forms are called "travelers." The first traveler gets
>>created when the device is built. A new traveler gets created every time
>>the device returns from the field (for upgrade or repair.)
>>
>>
>>
>>The forms show each part with its revision, part number, lot number, or
>>other attribute. There are different attributes for different types of
>>parts. Such as, software has a checksum, and a revision number while a
>>relay has does not. Instead, a relay has a lot number.
>>
>>
>>
>>Here are a couple of my challenges:
>>
>>
>>
>>I am modeling parts and assemblies, where an assembly is also a part. As
>>the devices come back from the field, they may get upgraded with
>>different parts and assemblies so the hierarchy is flexible. There seems
>>to be a many to many relationship between parts and assemblies. So, I
>>made a basic parts table:
>>
>>
>>
>>Part { ID, PartNumber, Name } where ID is the primary key
>>
>>Sample data:
>>
>>{ 1, 26.026, Enclosure }
>>
>>{ 57, 26.002, PCA }
>>
>>{ 113, 26.100, ECA }
>>
>>{ 114, 26.098, Xfrm }
>>
>>{ 115, 26.022, Xfrm }
>>
>>{ 116, 26.021, Xfrm }
>>
>>
>>
>>And I made another table to hold the many to many assignments between
>>parts and assemblies.
>>
>>AssyPartAssignment { ID, AssyID, PartID, Name } where ID is the primary
>>key and AssyID and PartID are foreign keys for the ID in the Part table.
>>
>>Sample data:
>>
>>{ 1, 113, 57, Controller PCA }
>>
>>{ 2, 113, 1, ECA Enclosure }
>>
>>{ 3, 57, 114, Xfrm T1 }
>>
>>{ 4, 57, 115, Xfrm T2 }
>>
>>{ 5, 57, 116, Xfrm T3 }
>>
>>{ 6, 57, 115, Xfrm T4 }
>>
>>
>>
>>The report needs to show this hierarchy.
>>
>>26.100 - ECA
>>
>> 26.026 - ECA Enclosure
>>
>> 26.002 - Controller PCA
>>
>> 26.098 - Xfrm T1
>>
>> 26.022 - Xfrm T2
>>
>> 26.021 - Xfrm T3
>>
>> 26.022 - Xfrm T4
>>
>>
>>
>>The same transformer, 26.022 shows up twice in the PCA assembly.
>>
>>
>>
>>I'll build more tables for the different attributes of parts, such as,
>>software with its checksum, and parts that have only lots, and parts
>>that have revisions and lots. I'll use the ID key from the Part table as
>>the primary key for the subtype tables based on the entity relationship
>>chapter from the CJDate book.
>>
>>
>>
>>I need to make the forms to enter these variable hierarchies.
>>
>>
>>
>>Got any suggestions that might put a little more holiday in my Labor
>>Day?
>>
>>
>>
>>Thanks,
>>
>>
>>
>>Eric
>>
>>
>>
>>
>>
>>--
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>>http://databaseadvisors.com/mailman/listinfo/accessd
>>Website: http://www.databaseadvisors.com
>>
>>--
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>>
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>>
>>
>
>
>
--
Marty Connelly
Victoria, B.C.
Canada
--
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