pharmamanufacturing Manufacturing Community Member 151 Posts
Re: Two monitoring systems26 January 2015 at 7:12pm Last edited: 26 January 2015 at 7:13pm
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.
To read more on this topic, download Vaisala's free ebook:
When you have two monitoring systems working in parallel -- a main monitoring system and a redundant set of sensors -- how do you defend (to a regulator) that one system provides the official record of conditions, and the other system is only to provide redundancy of recording in case of failure in the main monitoring system?
Have an insight or suggestion?
Login or register to post a comment.