Most technologies in pharmaceutical manufacturing are not only automated, but are able to notify other systems and key users of activities or unexpected events. In the microbial quality control laboratory, the manual test is still the standard, and users are keying results into systems such as LIMs. The lab generally does not see an alert until the sample is read at the end of an assay. The advent of automated rapid microbiological methods (RMM) changes the way the lab can operate. The enumeration and reporting process can be automated, with action and alert emails sent as soon as a sample is out of the specified range. The results of tests can be integrated to laboratory information systems (LIMS)--allowing for seamless data transfer between the lab and company-wide systems.
While automated rapid detection can operate in a standalone environment, the benefits to integration and email alerts are significant. Taking advantage of these capabilities often requires the technology to access the corporate network, an activity that requires the approval of the corporate IT organization. Most IT organizations are eager to help departments automate their processes, so long as the technology does not pose a risk for the business’ network infrastructure. It is important to engage the IT department early and understand the requirements of bringing new technology onto the network. Working with the IT department, the lab and automated rapid method vendor should prepare for the following types of requirements, many of which fall under 21 CFR Part 11.
Integral requirements for any business technology is limited, and access to the system is only granted by authorized individuals. The IT department will look to the technology and documentation to ensure that it includes protocols and procedures to limit access to only authorized individuals.
Operating System/Virus Protection
Most systems that reside on the pharmaceutical manufacturers’ network share common system setup, including things like virus software and automated system updates. As a result, IT policies may mandate the installation of additional technology on the instrument. The automated rapid vendor should work to ensure that any recently installed software does not interfere with the regular operation of the automated RMM technology.
Access to Operating System
Many automated rapid methods operate as an appliance, where the user never sees the actual operating system. This creates an additional layer of security to restrict users from accessing restricted components of the technology. The IT department will look to test the appliance to ensure that a typical user is not able to access the underlying infrastructure driving the system.
Finally, most internal policies and government organizations require microbial testing results to be saved for several years. To comply with these mandates, IT departments will review the technology to ensure that data can be retained for the required time frame.
For more information about the IT requirements of implementing a rapid system, contact us today for a free consultation or to schedule a product demo.