Life science companies have a GxP requirement to prove that temperature and humidity-sensitive products have been protected from extreme environments to maintain product quality. Usually this is accomplished with an automated monitoring system, such as the Vaisala viewLinc Monitoring System
When a company has multiple sites, there are economies of scale that make it financially attractive to invest in an enterprise-level system. An enterprise level system is a single centralized server installation that houses one monitoring application that is accessed by multiple sites over the corporate LAN. A common example of enterprise systems is corporate email; the email server is in an IT center at a central corporate location,
but employees can still send and receive email from different sites.
The centralization of a monitoring system and standardization on a single
server-based software installation can provide some substantial benefits. The primary benefits are cost-savings and risk-mitigation. On the cost savings side, only one server (or set of servers) is required, as well as fewer licenses. Because only one server needs to be deployed and validated, implementation and administration costs are reduced. In addition, having a single point-of contact with a monitoring system vendor increases leverage for technical support and purchasing power. Risks are mitigated because the single server can be well protected in a corporate data center. Additionally maintenance activities such as back-ups, disaster recovery, and change controls are more easily implemented.
There may sometimes be trade-offs in enterprise-level systems; for example: corporate solutions often require some compromise as different sites try to change their processes to work with the single solution. We can classify issues facing multi-site environmental monitoring systems into five broad types: Security, Administration, Geographic Variation, Multiple Site
Types, and IT Infrastructure.
Top Five Issues:
1 Security: There is a general tendency towards privacy in GxP companies and that holds true for monitoring. Nobody wants employees from other sites snooping into their area. Practically, this is a real issue as a multi-site system does present opportunities for uncontrolled changes by folks from other sites.
2 Administration: With many sites operating on the same software installation, administration can get complex, much as it would with a single large installation, except there are more stakeholders. As an example, some of our customers have over 4,000 sensors across their multi-site system. If you know monitoring systems, you know this means at least 8,000 alarm thresholds to manage.
3 Geographic Variation: As sites get more widely dispersed, they begin to be located in different time zones than the corporate server installation. Time-stamps are critical to monitoring systems, so collecting data from one time-zone, but storing it in another is a critical challenge. We also see different local languages in use for our international customers. Language matters as well, because it is always easier to work in your native language.
4 Multiple Site Types: Some multi-site systems involve different types of sites, ranging from warehouses and cold rooms, to laboratories, cleanrooms, and manufacturing suites. Each site type, by definition, will have different requirements. This is easily seen when comparing the types of measurements needed at each site. A cleanroom will have specific requirements for differential pressure measurements that aren’t necessary for warehouses and cold rooms. In addition to these practical differences, a system that isn’t a good fit may be perceived as a “corporate solution,” and suffer from other problems simply because there is no sense of local ownership.
5 IT Infrastructure: An enterprise-level system allows simplifying the hardware at the server end of the system only. The sensor end is more complex, as sensors need to be installed onto the LAN at each location. This can present challenges if the local site infrastructure is not ready to accept multiple new devices. There are often unexpected challenges such as physical installation of Ethernet drops, finding spare capacity on the network switches, bridging disconnected network segments, or insufficient bandwidth and signal strength if using wireless devices.
Before we offer up our take on solutions to these challenges, let’s look at how these challenges manifest themselves in different applications. There are three main types that face the challenges of multi-site monitoring: National Warehouses, Regional Hospitals, and Global Manufacturers.