However, this new paradigm will be a challenge to pharma executives because it is not a simple matter of extending conventional
corporate IT systems and management approaches down to the manufacturing plant level. Reporting requirements and public safety
regulations make IT systems reliability a much higher priority at the manufacturing level than in the general corporate IT
environment. Outages and glitches common in corporate infrastructures are a much more serious issue in pharmaceutical manufacturing.
If a pharma company can't document every step it takes to set up, process, and verify a batch, US and European regulations
compel them to scrap it. EBR systems, for example, must collect data constantly because even one break in the electronic record
chain can turn a million-dollar batch of medication into that quarter's biggest loss. For PAT to provide real-time quality
control and key process parameter recording, its underlying computing infrastructure must be free of crashes and service interruptions.
Figure 1. An Electronic Batch Record System An electronic batch record (EBR) system draws data from many systems in pharma
manufacturing plants. The network infrastructures between and within the systems are breeding grounds for outages and system
interruptions and must be factored into plans for implementing an EBR system.
That need — for much higher reliability than conventional IT infrastructures provide — demands a new mindset from pharma executives,
many of whom have solid backgrounds in corporate and scientific IT, but not in manufacturing IT. The mainstream business approach
of consolidating IT systems at corporate data centers does not apply to manufacturing. Manufacturing data collection systems
must be situated in relatively close proximity to the process, not at a remote data center. Plant-level IT staffs, however,
don't have the resources or expertise to maintain the ultra-high reliability – 99.999 percent uptime – infrastructure that
this new pharma manufacturing IT paradigm demands.
The challenge for pharma executives is to implement at the plant-level technologies and management practices that eliminate
crashes, service interruptions, and performance degradations, while not increasing the plant IT budget, overburdening the
existing staff, and risking regulatory non-compliance. As they move to meet the reliability challenge, pharma executives must
understand the language of providing 99.999 percent uptime. There are many IT product and service vendors that tout phrases
like "high-availability," "high reliability," and "continuous availability" for their products and services, but few of them
provide 99.999 percent uptime. This article defines continuous availability as a system (hardware or software component) or
integrated group of systems that is designed, manufactured, and delivered with an availability of 99.999 percent uptime or
more, and is maintained at this level through an ongoing quality management process.
PHARMA'S RELIABILITY NEED
While most industries consider 97 to 98 percent information system availability excellent performance, the remaining two or
three percent can represent huge financial losses and risk of non-compliance for pharmaceutical EBR and PAT implementations.9 Failure rates as low as two to three percent are unacceptable because they break the process monitoring and record chain,
which results in spoiled batches with all the accompanying losses. Without uninterrupted operation, EBR and PAT solutions
will not pay off as a cost-effective, risk-based approach to electronic record compliance and the manufacturing efficiencies
that go with it. Therefore, the IT infrastructure that supports these applications must exceed standard corporate benchmarks
of reliability, availability, and uptime.
From the outside, a continuously available manufacturing infrastructure resembles a conventional IT environment. It consists
of servers running applications, databases, storage, and networking components. The servers are linked with storage arrays
by router-based networks running protocols over hard-wired and (more recently) wireless connections. In a manufacturing environment,
interfaces with plant floor systems pull in data from individual process execution systems.