Some firms implement a BMS and CMS in parallel. Often this can signify to inspectors that your firm has a real commitment to continuity of records. Generally one system is declared the “system of record” and differentiated from the “control system.” However, the outputs from two different systems are quite different;often a BMS includes many kinds of sensors and controls that require custom programming. This customized programming makes the validation process, necessary for GMP, quite costly.

A more cost-effective option can be an off-the-shelf CMS designed for GxP applications. This second system can provide the requisite documents for inspection and audit processes and be the “system of record.” In addition, many monitoring systems can include redundant recording, so that even in the event of power or network downtime, the records are continuous.

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Using GAMP Methodology to Select & Validate Monitoring System Software