One of the requirements of building and operating an IT infrastructure in a highly regulated industry (such as the pharmaceutical industry, which is regulated by the FDA) is to qualify, or validate the servers, network, and storage when they are being built. Once built, any changes to the infrastructure should undergo a change control procedure.

Building the infrastructure and making changes to it should undergo verification. They should also be documented so that they can be easily managed and traced. These activities are really not that different from the best practices guide in operating an IT infrastructure, or even from the ITIL processes.

FDA does not dictate how to perform IT infrastructure qualification or validation, as long as you have documented reasonable procedures.

The problem is that some companies overdo validation and change control processes. The common problems I’ve seen are: (1) too many signatures required to make a change, (2) no automated procedure to perform the documentation – many still use papers to route documents (3) and finally, the people who perform the checks and balances sometimes do not understand the technology.

The result is that IT personnel get overwhelmed with paperwork and bureaucracy. This discourages them to make critical changes to the infrastructure such as performing security patches on time. This also leads to the relunctance of IT personnel to implement newer or leading edge technologies into their infrastructure.

Fortunately, the International Society for Pharmaceutical Engineering (ISPE) has published a Good Automated Manufacturing Practice (GAMP) guidance on IT Infrastructure Control and Compliance. Companies can create their own IT infrastructure qualification program and procedures based on the GAMP guidance document. They should be simple but comprehensive enough to cover all the bases. It is also important that these procedures be periodically reviewed and streamlined to achieve an optimized procedure.