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Memory management techniques that prevent processes from accessing each other s address spaces. I/O controllers that prevent programs from simultaneously attempting to write to a peripheral device. Schedulers that ensure (through interrupts and preemption) that one process will not hog all system resources. Synchronization primitives, such as mutexes and semaphores, that manage access to a critical resource shared by two or more processes.

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If the system replaces another system or a manual system, there will also be a number of other SOPs describing the old way of working that need to be updated due to this new system List all appropriate procedures and state that these need to be assessed for changes, how the assessment is to be documented for each SOP, and when the SOPs are to be updated In some cases, it is just a matter of changing the name of the old system to the name of the new system; in other cases, the whole work ow changes, which means that the SOP has to be completely rewritten A glossary should be included in the VP only if there is no other glossary in the QMS or VMP, or if the expressions used are not included in the other glossaries.





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The two terms in (9.9) corresponding to the edges 0 [0, T ] and 1 [0, T ] are equal and equal to

Again: Don t repeat this work if it already exists somewhere else Errors are likely to be found during testing These may be handled according to normal error-handling procedures in the organization, but sometimes these procedures are not optimal for the validation project Explain how errors will be handled during the project This is covered in more detail in Table 112 Table 113 is a form that can be used for error handling The text and the form need to be in synchronization Likewise, change control may need to be done differently during the project For example, sometimes there are errors in the test scripts, and it must be possible to correct and change these scripts without involving a lot of other people.

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It should also be permissible to add new test scripts after the test protocol has been approved, but not to omit any that have been approved Validation does create a Giant Mass of Paper (also nicknamed GMP) It might be wise to create an archiving system for all documents generated for this system This is relevant if the organization uses paper archives Some organizations have requirements for archiving one type of document in one place and another type of document somewhere else In that case, you should discuss whether copies of all documents should be deposited in the system archive This isn t an issue if documents are archived electronically in a Document Management System (DMS), where they can be tagged with the system name However, that will require the DMS to be validated and under control, with documented access rights, an audit trail, and so on.

Electronic storage of, for example, Word and Excel documents in a dedicated server directory isn t considered as a document management system, because the security, audit trail, and access are insuf cient The testing should be done on the test instance of the system (the various instances are described in 5) Include text to make sure that all data from validation, quali cation, and testing is backed up and archived This is very important quality data, and without it you suddenly don t have the raw data and your validation effort is worthless We do need a Validation Plan We need a separate VP for revalidation only if the VP (or another QMS document) states that this is needed Sometimes the revalidation consists of only one of the IQ, OQ, or PQ The single quali cation effort can then be controlled by the IQ, OQ, or PQ plan.

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