Definition Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records

E

ehrbs27

#1
In the '4.2.5 Control of records', the standard requires the document procedures to define the controls needed for the integrity.
I don't know about the integrity meaning in this standard.
Please help me :bonk:
 
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Marcelo

Inactive Registered Visitor
#2
Re: the meaning of the INTEGRITY in ISO 13485

Integrity = wholeness.

The requirement is basically to prevent you to tore it to pieces in a way that make it unreadable.
 
E

ehrbs27

#3
:thanks:Thank you for your reply.
But I do not understand yet :(
Does it mean to preserve the document perfectly?
Or not to seperate the contents of 'record'?
 

Marcelo

Inactive Registered Visitor
#4
Does it mean to preserve the document perfectly?
If that's required to "provide evidence of conformity to requirements and of the effective operation of the quality management system", yes. But lease note that you define the controls.

Or not to seperate the contents of 'record'?
Hum, I'm note sure what you mean here.
 
E

ehrbs27

#5
If that's required to "provide evidence of conformity to requirements and of the effective operation of the quality management system", yes. But lease note that you define the controls.
OK
Oh, i understand it.:):):)

Hum, I'm note sure what you mean here.
I mean, do not divide as you like. for example, if you have a record "a/b/c/d/", then you should not divide it by "a", "b", "c" or "d"
 

Jean_B

Trusted Information Resource
#6
I mean, do not divide as you like. for example, if you have a record "a/b/c/d/", then you should not divide it by "a", "b", "c" or "d"
I'd say you can still divide it to a, b, c and d parts, as long as removal of any one of the parts is prevented or noticeable.

For example, a summary record of e (all of the above) on a, b ,c and d means you can no longer delete and c and never know it existed.
Another way would be to reference for example this as being part 2 of 5. This would be similar to page numbers which can also denote wholeness or integrity of a document.

Taking it to the next level would involve test-suite setups, where later sections do not replace the previous one in an identifiable (e.g. part 2 under rev 1 to a different part 2 under revision 2) but take a unique place in an expansive set.
This is the core principle behind the often little understood practice of decadal (groups of ten) increments in manual maintenance of for example requirements documentation. This practice allow additions to the requirements set later on to still follow some imposed logical structure (for a little while). Else it could seem that a requirement has either transformed (replacement damages long-term integrity of directly referencing the requirement without the higher-level document identifier) or having a catch-all 'these all came later' numbered set of additional requirements at the end making reading and execution of protocols more difficult.
 

Ninja

Looking for Reality
Trusted Information Resource
#7
In the '4.2.5 Control of records', the standard requires the document procedures to define the controls needed for the integrity.
You can find them.
Everyone who needs to access them can find them.
They are not lost.
They are not changed.
I can trust that when I read it, I am reading the correct version.
When I read it, I can see all of it.
No one changed it without authorization.
It can still be trusted after your computer network crashes.
Bob on the shop floor didn't mark up changes on it when he was angry.

Whole. Trustworthy. Reliable. Complete.

Data Integrity: Data integrity is the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle. {Wiki definition...and right on the money}
 
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