Proofreading System (CCD camera reading labels) vs. 21 CFR part11

G

Guevara

Hello all,

I'm looking for ideas as to how address 21CFR part 11 applicability to a proofreading system (CCD camera reading labels). Main goal is to take proper action so system could be labeled ''21CFR part 11 compliant''.

Process Flow:

1 - master label selected in computer
2 - setup of allowed discrepencies
3 - trial run
4 - on going inspection
5 - if discrepencies detected, flip/flop system pull aside non conforming unit
6 - No link to network, system is not linked to previous or following manufacturing station and end of the shift count dislpayed on screen is validated with physical count of defective units.

Hope this gives a clear picture:evidence:


I've been going through lot of documentation on the net, but it seems to avoid this specific application.

:thanx:
 

Marc

Fully vaccinated are you?
Leader
I checked the site linked to and didn't see anything which answers the question. Can anyone here help out?
 
M

MIREGMGR

Have you already established FDA-satisfactory process validation, including software validation?
 

Jim Wynne

Leader
Admin
Re: Proofreading System vs 21CFR part11

Hello all,

I'm looking for ideas as to how address 21CFR part 11 applicability to a proofreading system (CCD camera reading labels). Main goal is to take proper action so system could be labeled ''21CFR part 11 compliant''.


:thanx:


From the FAQ page on the site that Dean linked to:
What must a vendor do to claim that their hardware and software are 'compliant' with 21 CFR Part 11?

No vendor can claim that his or her software products are certified Part 11 compliant. A vendor, instead, can say that he has all of the Technical Controls for 21 CFR Part 11 compliance built in to his product. Remember, it is the responsibility of the user to implement the Procedural and Administrative (and correctly and consistently) Controls along with using products with the correct Technical Controls for overall Part 11 compliance.

I'm no expert in this area, but if the information above is accurate, you can't do what you want to do ("...to take proper action so system could be labeled ''21CFR part 11 compliant'').
 
G

Guevara

:bigwave:

Glad to see some action happening regarding my request.

To be more precise, my fied of action is concentrating on the hardware itself (computer, CCD, software) and flip/flop system). We 're trying to develop documentation that would ease end user job to be 21 CFR part11 compliant.

I think a good starting point could be a check list that would evaluate which 21CFR part 11 items our system would be entitled too.

Am I right?
 

yodon

Leader
Super Moderator
Based on your description, I don't see where part 11 is in play. What predicate rule are you trying to satisfy that requires part 11 compliance? That's always the first question to ask.

As MIREGMGR pointed out, you certainly need to validate this process / software but as far as I can tell, this should be all you need.
 
G

Guevara

Based on your description, I don't see where part 11 is in play. What predicate rule are you trying to satisfy that requires part 11 compliance? That's always the first question to ask.

As MIREGMGR pointed out, you certainly need to validate this process / software but as far as I can tell, this should be all you need.

We would like to assess how easily our system could by implemented to a manufacturing line by identifiying key items that might be concerned by 21 CFR part 11 depending on the scenario of detection (labelling, defects on bottle, foreign particles).

:thanx:
 

yodon

Leader
Super Moderator
We would like to assess how easily our system could by implemented to a manufacturing line by identifiying key items that might be concerned by 21 CFR part 11 depending on the scenario of detection (labelling, defects on bottle, foreign particles).

:thanx:

Let me see if I understand your situation: you have (or want to have) a manufacturing process that takes a label master (electronic file, I presume), prints the label on label stock, and applies the label to your product. Am I close?

If this is the case, your labeling process certainly needs to be validated - which should include assuring security of the label master. All of the defects you mention are part of the manufacturing process validation. In my experiences, this has not required part 11 compliance.

I guess I could see where management and control of the label master might require part 11 controls. The companies I've worked with in the past printed a copy of the master on an ECN form for approval (and the ECN was hardcopy so no concern there).

The companies we have supported did just as I describe above, have been audited by the FDA, had no part 11 controls (on the label master) and have not had any issues. They were able to show the label masters were well-controlled.

Does that help? Am I understanding what your question is?
 
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