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Validation protocols are required to describe the objective, methodology, and acceptance criteria for installation, operational, and performance quali cations They are written to ensure test methods, and acceptance criteria are reviewed and approved before quali cation of protocols In practical terms, there are several stages for the production of protocols First, an acceptable format needs to be agreed No universal format exists for protocols, but to some extent, the type of equipment, the size of the project, and the personal preferences will dictate the protocol style However, some norms have been established Like other controlled documents, protocols are assigned unique reference numbers and revision numbers They are titled and numbered on every page and have a particular place for approval signatures Other common elements in protocols tend to be brief descriptions of the item being quali ed and a clear statement of responsibilities.

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displayPageHeader(); > <h1>Member Signup: Step 1</h1> <form action= exercise2.php method= post > <div style= width: 30em; > <input type= hidden name= step value= 1 /> <label for= firstName >First name</label> <input type= text name= firstName id= firstName value= < php setValue( firstName ) > /> <label for= lastName >Last name</label> <input type= text name= lastName id= lastName value= < php setValue( lastName ) > /> <div style= clear: both; > <input type= submit name= submitButton id= nextButton value= Next > /> </div> </div> </form> < php } function displayStep2() { displayPageHeader(); > <h1>Member Signup: Step 2</h1> <form action= exercise2.php method= post > <div style= width: 30em; > <input type= hidden name= step value= 2 /> <label>Your gender:</label> <label for= genderMale >Male</label> <input type= radio name= gender id= genderMale value= M < php setChecked( gender , M ) >/> <label for= genderFemale >Female</label> <input type= radio name= gender id= genderFemale value= F < php setChecked( gender , F ) > /> <label for= favoriteWidget >What s your favorite widget *</label> <select name= favoriteWidget id= favoriteWidget size= 1 > <option value= superWidget < php setSelected( favoriteWidget , superWidget ) >>The SuperWidget</option> <option value= megaWidget < php setSelected( favoriteWidget , megaWidget ) >>The MegaWidget</option> <option value= wonderWidget < php setSelected( favoriteWidget , wonderWidget ) >>The WonderWidget</option>

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Often the protocol will incorporate test sheets or sections for recording data In this way, once the protocol has been executed, the document constitutes a record of the results and conclusion [3] It must describe the activities to be performed in a validation, including the acceptance criteria for the approval of a manufacturing process or a part thereof for routine use [1] A validation protocol is necessary to de ne the speci c items and activities that will constitute any validation study It is advisable for companies to draw up a VMP indicating the overall validation strategy for either the product range or equipment type or the entire site.

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The protocol must be prepared before initiation of the study and must either include or refer to the documentation required to provide information about a speci c process, the parameters involved in that speci c process, the personnel responsibilities, and the acceptance criteria The list of items to be quali ed in the validation protocol must be produced and the approach agreed upon There are several procedures to perform the validation protocols Nevertheless, it is important that the approach agreed upon is executed to ensure internal consistency and prevent items being inadvertently forgotten Thus, for instance, it is possible to group identical items together under one protocol or to have a protocol per item A single or multiple protocols can be written covering installation quali cation (IQ), operational quali cation (OQ), and design quali cation (DQ).

The Simplified Wrapper and Interface Generator (SWIG) is a development tool designed to connect C and C++ programs with high-level languages, including, but not limited to, Python, Perl, and Tcl/Tk. It is especially useful for creating an extension module from an existing C or C++ library. In some cases, it can generate all the interface code automatically. SWIG is free for commercial and private use and is available from www.swig.org.

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