Harmonization of C&Q and CSV Initiatives

“In many instances there is significant overlap between the computerized system validation and the commissioning and qualification activities specially for computerized control systems utilized in the manufacturing, facilities and/or utility processes (e.g. PLC’s, SCADA, DCS). As such, these efforts may be combined under one effort, to ensure proper synchronization and preclude duplication of effort. As a result, a single validation/qualification effort may be performed to produce the required deliverables to achieve compliance while harmonizing work being done even when using different teams. Moreover, the commissioning effort can reduce significantly not only the qualification effort but also the CSV effort, if performed appropriately.

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In today’s competitive environment, clear and concise policies and procedures that promote such harmonization effort, regardless of the type of regulated manufacturing process and automation platform, will offer significant value by reducing the cost as well as the time it will take to complete such projects while still meeting the required level of compliance.

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