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Validation performance must be under the responsibility of appropriate and experience personnel that should represent different departments depending on the validation work to be performed Validation should be performed for new premises or equipment, utilities, or even systems, processes, and procedures at periodic intervals and when major changes have been made in accordance to written protocols Validation can be prospective, concurrent, or retrospective, depending on when the validation is performed There should be a clear distinction between in-process controls and validation In-process tests are performed during the manufacture of each batch using speci cations and methods devised during the development phase The aim is to monitor the process continuously and not exactly validate it When a new manufacturing formula or method is adopted, steps should be taken to demonstrate its suitability for routine processing prior to the validation.
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example is a banking transaction in which $100 is transferred from a savings to a checking account. This transaction really involves three steps: 1. Subtract $100 from savings. 2. Add $100 to checking. 3. Record the transaction in the transaction log. If any of the preceding statements fail individually, you will have problems. If the customer doesn t have $100 in savings, you will hand him or her free money to put into their checking account. If a problem occurs in adding the money to checking, you will have an upset customer. If you can t log the transaction, you will have bookkeeping problems in the future. Oracle addresses this problem with the commit, rollback, and savepoint statements. No data is saved permanently to the database until a commit is issued. The commit is the end of the transaction, and the first SQL statement issued either in a session or after a commit is the beginning of the session. If you run into trouble halfway through a transaction, you can issue a rollback to tell Oracle to ignore all the statements that have been executed so far in the transaction. The database is rolled back to the state that it was in before the start of the transaction. You can also specify a savepoint, which is an intermediate commit. At the time you issue a savepoint, no data is permanently written to the database; instead, you have a point to roll back to other than the beginning of the transaction. This can save time and horsepower, because you don t have to repeat all of the work that was done before you issue the savepoint, which is presumably okay.
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The de ned process using the materials and equipment speci ed should be shown to yield a product consistently of the required quality Essential validation work must therefore be identi ed to prove control of the critical aspects of the operations A risk assessment approach should be used to determine the scope and extent of validation..
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0 2400 1200 Clock time (h) 2400
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Figure 18-6: A title block can be saved as a file and inserted into any other drawing. 6. Use Zoom Window to zoom in on the text at the bottom-right corner of the title block. At the Select objects: prompt, select all of the 90 -rotated text at 1 in Figure 18-6. Press Enter to end selection. 7. In the Base Point section, click Pick Point. Use the Endpoint object snap to pick the bottom-left corner of the box containing the text that you selected. Using this base point lets you easily place the text in the box at any time. 8. In the Objects section, choose Delete from drawing. 9. In the File Name and Path text box, type notes-tol after the path, which should already be set to your AutoCAD Bible folder. Click OK to save the block as a file. 10. Type oops to bring back the text. 11. Choose Zoom Extents from the Zoom flyout of the Standard toolbar (or choose View Zoom Extents), and save your drawing.
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