IS0 13485:2003 - Validation of the Application of Computer Software

pbojsen

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#41
Re: IS0 13485:2003, Validation of the application of computer software

More. This will take a few postings so please bear with me.
 

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pbojsen

Involved In Discussions
#42
Re: IS0 13485:2003, Validation of the application of computer software

Not done yet. BTW, these are made to be scalable for use on large and small systems, which is why you will see some "combination" type templates, such as the Requirements and Specifications.
 

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pbojsen

Involved In Discussions
#47
Re: IS0 13485:2003, Validation of the application of computer software

As for the latest from the FDA, here is the link that the FDA made for regulated industries. At least you don't have to try to find it from the consumer's website.

http://www.fda.gov/oc/industry/default.htm

You will find all sorts of interesting information, like "Inspection of Medical Device Manufacturers" in PDF form.

There are also the latest guidance documents, such as the attached.
 

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A

Alfred888

#48
Re: IS0 13485:2003, Validation of the application of computer software

Dear pbojsen:
Thanks for sharing all the templates.
I work for a small company, with no IT dept. (we use Macs, except only some PCs for data acquisition). I am stuck with the task of validating the Excel spreadsheets used for calculations e.g. HPLC analysis, in addition to doing other R&D and QC tasks in lab.
Your templates will help us save time and money. Thanks again.
BTW, do you have more to share?
Alfred.
 

k3nny

Periodic Visitor
#49
Re: IS0 13485:2003, Validation of the application of computer software

In 2006, we implemented MFG PRO EB2 to manage the day to day production activities. As a part of this endeavor, I spent countless hours with an external validation service.

The statement that this is a risk based / science based effort is truly correct. The process looked similar to a product/process project management effort. Initially, we identified through business requirements the scope of the project. Warehousing, Manufacturing, and Purchasing encompassed 85% of the validation test scripts.

The next step was to define the Validation Master Plan. In this document we identified the risk level. In our case, the MFG PRO system was our ERP system not controlling software on a device - so our exposure to injury was only through the mis-handling or mis-shipment of incorrect devices.

We built an Installation Qualification to define what the server that handled the MFG PRO software would look like as well as the environment (instance management).

The OQ was the meat of the validation. We executed many scripts - primarily manual test scripts - that tested specific functionality that was developed from the Business Case/ Requirements. This testing was for specific functionality like warehouse transfers.

The PQ was an end-to-end set of tests that tested a string of requirements such as order to cash. We needed to be able to recall product so it was important to know who we sold it to (obvious, I know).

The final two documents were:
1. Summary indicating all is well
2. Trace Matrix that mapped the business requirements through OQ test scripts, PQ test scripts, and a final result.

We had failures that forced our ERP group to re-group and follow change control guidelines.

I learned from this process, but most importantly found that good project management practices are worth there weight in gold. Change Control, Resource Control, as well as other systems MUST be developed before you get going.

Good Luck.

Ken
 
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wnd54

#50
Re: IS0 13485:2003, Validation of the application of computer software

I am a quality manager for a class I device manufacturer. I'm having a debate with engineering about Pass/Fail criteria and final V&V reports for product transfer. In my past experience, if therre is one fail on a test report, the whole test fails and the information is fed back into the design process to be corrected. My engineering peers think that it is okay to show that a test case fails but still pass the verification or validation.

1) Does anyone with software experience agree that you can pass a verificaation or validation when one of the tests fail?

2) When running a V&V for software, one is sure to uncover bugs. Based upon risk, you might choose to address a software bug in a later version. Our QA group captures these bugs on the V&V report. I look at this as passing a test step with an exception. How does one address software bugs when the test case actually passes but a minor bug is found?

Any guidance or help would be greatly appreciated
 
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