rdlc data matrix

rdlc data matrix

rdlc data matrix

rdlc data matrix

rdlc data matrix

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The company Validation in Partnership Ltd has issued a compilation of the requirements for HVAC systems [10] that includes relevant references to the European and US regulations and guidelines They have also listed ndings from 4200 warning letters and 3100 483s From this, it is easy to see that validation of the HVAC and BMS systems is relevant This document only covers the environmental system and monitoring, and does not even mention the computerized BMS system that controls the environment The ISPE GAMP BMS position paper [11] lists a number of warning letters with citations for the lack of validation of BMS systems, with wording equivalent to that of Table 194 More can be found on the FDA web page for warning letters There is no doubt from these citations that high-impact BMS requires validation The need for validation of BMS systems has been discussed for years.

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The various ISPE Baseline guides have different views on the validation and quali cation of BMS Some of these can be attributed to the author of this particulate part of the guide Others are, instead, supported by the view that BMS is so complex that it is easier not to validate the system The result is that the baseline guides offer differing solutions, ranging from no need to validate if the systems are monitored to need to validate When an independent and calibrated monitoring system is in place, the need to validate a system also raises some questions The BMS Position Paper from ISPE/GAMP discusses the need for validation of BMS systems, the conclusion being that it s a matter of assessing risks, which are not to be taken lightly.

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Older systems that have been added to over the years are more dif cult to validate than newer systems, where validation can be done during implementation Avoid retrospective validation as that is close to mission impossible Most companies would rather implement a new system that can be validated than try to validate an old system The current thinking for any validation is to assess the risks involved in not validating the item in question The question of whether or not to validate HVAC/BMS should also be assessed for risks before a decision is made If the HVAC/BMS has a direct impact on the product, risk assessment will show that the system needs validation If the system has no impact, the need isn t there The discussion will usually cover the parts of the system.