Electronic Records and Software Development

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D

Duke Okes

#2
"Is software code an Electronic Record?"
To me it's same as a "document" which must be controlled (e.g., revision level, approval & release). A record is something that is usually not changed.

Documents/software are an input to an operating process, records are an output.
 
J

JaneB

#3
"Is software code an Electronic Record?"
More info needed. What kind of software code are you talking about? In what context?

If for example, that code is something that you're developing and delivering for a customer as a deliverable or part thereof, then treat it as product (or component of).

If it's code that, say, records something was done (eg, a transaction made in a system) then yes, it's a record (in electronic format).

PS Duke, better to think of a record as recording a 'snapshot in time'; while they usually aren't changed, it's not true that they can never/should never be changed.
 

sagai

Quite Involved in Discussions
#4
Using terminology in the predicate rule,cGMP, in case Source Code is part of your finished medical device, than it is part of your Design Output.
What is the origin of your question?
Terminology Electronic record coming from a slightly different direction, namely the application of 21CFR11.
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T

tflahive

#5
Thanks for the help.

For those who requested more info...

The software is proprietary software, which is used to transmit the output of a medical device.
 
J

Jerome

#6
Still like to know why you'd think it would be an e-record.
Do you use it as documented evidence of the design or something? (I hope not :D )
And how do you have defined what a record and/or electroic record is?
I general I would not state that source code is an electronic record.
It's a (complex) set of commands from which a program/product is compiled.
Other than that I concur with JaneB.
 

sagai

Quite Involved in Discussions
#7
Still like to know why you'd think it would be an e-record.
Do you use it as documented evidence of the design or something? (I hope not :D )
And how do you have defined what a record and/or electroic record is?
I general I would not state that source code is an electronic record.
It's a (complex) set of commands from which a program/product is compiled.
Other than that I concur with JaneB.
I have a terrible feeling, it is only guessing, its may be about to eliminate the need for configuration management system and version control the source code as an electronic record. ....
 
J

Jerome

#8
What is the defenition and purspose of an electronic file and in what context should it be placed to mark it as such?
 
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