Implementation of the FDA requirements into the existing Quality Management System

[HANIMAGA66]

Hello,
by a long search in the Internet I am encountered to this forum side.

I write straight my thesis (diploma) with the topic: Implementation of the FDA requirements into the existing QM-System.

We are a small business in Germany, which is ISO 9001:2000 and 13485 certifiied. To marked our product into the U.S. our company need the FDA approval. I found that I must implement the requirements 21 CFR part 820 into our QM-system. I put on a table, where the comparison of the requirements with our system is evident and whether our system fulfills the requirements or not. I am now so far that I made the comparison to implement and now beginning would like. I have momentarily the problem that I so really do not point, as exactly I am to describe a procedure.

For Example: CAPA procedure: In our system this procedure is only partly mentioned. Then I provided a standard practice. And forms. Subsequently, I experienced from my boss that like already have a software which is FDA compatible. Is it sufficient if I write into our system that a software existed and that this is used, or must I provide/write a standard procedure?

I think my problem is now, that i don't know how i can implement the missing procedures. Well, looking to my table, I can see, that there isn't missing a complete procedure, only some specified concepts and/or forms.

For my bad mode of expression I would like to excuse and hope myself that I could describe my problem.

Thank you in advance for your help.

Yours sincerely

HANIM-AGA66

[Marc]

Your procedure should state what you use, and if it is complex or difficult how to use it if not described elsewhere.

[Marc]

I moved this to the FDA forum. It might attract a more attention here considering its focus.

[HANIMAGA66]

Thank you

[Al Rosen]

Originally Posted by HANIMAGA66

Hello,
by a long search in the Internet I am encountered to this forum side.

I write straight my thesis (diploma) with the topic: Implementation of the FDA requirements into the existing QM-System.

We are a small business in Germany, which is ISO 9001:2000 and 13485 certifiied. To marked our product into the U.S. our company need the FDA approval. I found that I must implement the requirements 21 CFR part 820 into our QM-system. I put on a table, where the comparison of the requirements with our system is evident and whether our system fulfills the requirements or not. I am now so far that I made the comparison to implement and now beginning would like. I have momentarily the problem that I so really do not point, as exactly I am to describe a procedure.

For Example: CAPA procedure: In our system this procedure is only partly mentioned. Then I provided a standard practice. And forms. Subsequently, I experienced from my boss that like already have a software which is FDA compatible. Is it sufficient if I write into our system that a software existed and that this is used, or must I provide/write a standard procedure?

I think my problem is now, that i don't know how i can implement the missing procedures. Well, looking to my table, I can see, that there isn't missing a complete procedure, only some specified concepts and/or forms.

For my bad mode of expression I would like to excuse and hope myself that I could describe my problem.

Thank you in advance for your help.

Yours sincerely

HANIM-AGA66

Your Capa procedure must address all the items outlined in 21cfr820.100. The procedure should address the following:

1. Analyze inputs such as quality processes, manufacturing operations (non conformances), audit reports, service reports, customer complaints and any other sources of quality data. Use statistical techniques where appropriate.
2. Investigate the causes of nonconformities.
3. Identify the actions required to correct and prevent reocurrance.
4. Verify the actions are effective and do not adversely affect the finished device.
5. Implement and record the changes required.
6. Inform those responsible for the quality of the product.
7. Submit the information on the CAPA activities during management review.

If you can provide us with more specific questions, we can help you better.

[HANIMAGA66]

Hello again,

To me is already conscious that our system must fulfill the requirements, only lies the problem in the fact that I cannot begin anything with this conceptualnesses. I'm missing examples think I.

For the CAPA procedures we have, like said, already a software.
And according to my setting of tasks is it nevertheless like that, that I must look, whether in our QM-System (that what is located in our QM-Manual) the CAPA procedure is present.Isn't it sufficient then, if I would write, there is a software present, which is used?

[Al Rosen]

Originally Posted by HANIMAGA66

Hello again,

To me is already conscious that our system must fulfill the requirements, only lies the problem in the fact that I cannot begin anything with this conceptualnesses. I'm missing examples think I.

For the CAPA procedures we have, like said, already a software.
And according to my setting of tasks is it nevertheless like that, that I must look, whether in our QM-System (that what is located in our QM-Manual) the CAPA procedure is present.Isn't it sufficient then, if I would write, there is a software present, which is used?

No, you need more detail. My previous post listed what you need to describe.

[HANIMAGA66]

Ok. I have unterstand. Thank you for your information.