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not have to repeat what the supplier has already done GAMP 5 [11] also advocates this approach and gives guidance in the process This is allowed provided that the user has made a risk assessment the conclusion of which is that this is an acceptable risk But what skills are needed to come to that conclusion That will, of course, require knowledge of risk assessment Most companies have QA people with a background in production or laboratory work, and with extra training in standards The combination of this knowledge and understanding of Quality Assurance makes good auditors for performing audits within their eld While many internal auditors do have the knowledge to perform an audit, few companies have internal auditors who really know what to look for when auditing an IT supplier The auditor must understand how software should be developed.

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It is not suf cient to see whether the audited company has a quality system and that they are following it The auditor must also be able to understand what is not included in the quality system, or what is not described well enough in the quality system Earlier, the FDA did not acknowledge anything but a do-it-yourself audit, which generally is a lot less well done than a TickIT audit/certi cation The FDA and EU authorities now accept a risk-based approach where you (as a user) can leave a lot to the supplier I have always said that I trust the development of the software if the supplier has a TickIT certi cation, as I know what that entails Now it actually should add value, as it could reduce the number of customer audits.

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So in my opinion it would be wise to have certi cation, provided that we can make the pharmaceutical industry understand that this is a valuable part of the system development that they don t need to repeat for themselves Fewer audits are, of course, also a bene t for the supplier, who does not need to host as many audits Only if the supplier has been audited by highly skilled auditors can any conclusion be made about the supplier s performance in the quality arena There will be a great need for skilled auditors who know what they are looking for They must also know how to document exactly what they have seen and what was missing Only then can any conclusions be drawn about the supplier s performance.

Here are a few pointers for wrapping a graphic around a jump menu: Use a flat color not a gradient as the background for the menu. Work with Web-safe colors in the graphics program; they re far easier to match in Dreamweaver. Set the background color of the graphic to be the background color of the cell of the table holding your jump menu. Make sure you leave enough height in your graphic to accommodate the jump menu in all browsers. Netscape displays a standard list/menu form element approximately 24 pixels high on a PC; try leaving about 30 pixels in your graphic. Form elements are drawn by the user s operating system and are vastly different on each platform. Test your designs extensively. Integrate your Go button, if you re using one, right in the graphic. Be sure to set it as its own slice, so that it comes in as a separate image and can be activated with a Jump Menu Go behavior. In the following figure, a graphical Go button appears to the right of the jump menu.

If, and only if, the thorough audit report shows that the supplier is up to the company s expectations from a quality point of view, some of the testing can be omitted during the company s own validation I m afraid that a risk-based approach with the conclusion that we need to do less will be founded on lack of understanding and knowledge, because the auditors are not trained well enough for software audits It may be wise to team up with external consultants who have this knowledge However, don t leave the work to the consultants Join them during the audit After all, your company is the one to be inspected by the authorities, and you need to be a part of the audit to see what has been done..

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PDF417 Barcode Fonts - Barcode Resource
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