Q: Are there FDA guidelines or regulatory requirements for maintaining specific environmental conditions for industrial PCs (HMI, SCADA, DAS, etc.) used in manufacturing operations? If yes, what should be the ideal limits?
A: Your question comes from a pharmaceutical perspective but applies equally to medical devices, foods, and other FDA-regulated industries.
FDA regulations tend to be “generic”. The cGMP rules apply to all products in very broad industry categories. It would be impossible for FDA to create specific rules, guidelines, and conditions for the specific use of computerized systems in all the diverse environments where they are used today.
Instead, the Agency requires you to determine and enforce your own environmental conditions for safe and effective operation of computerized systems in relation to their specific locations and uses.
“The same system used for different purposes may require very different controls and environmental needs.”
In other words, the same system used for different purposes (even by the same manufacturer and even in the same production facility) may require very different controls and environmental needs (including maintenance), based on its specific location and use.
Keep in mind that, in FDA’s eyes, a computerized system includes not only hardware and software but also people, procedures and processes that yield data.
So your first step for defining specific environmental conditions is to determine and document your requirements and the intended use of the computerized system. Next, let the design of your manufacturing process and its flow determine the physical placement of the computerized system in the manufacturing environment.
Then use your validation process to demonstrate the adequacy of your requirements and your chosen computerized system. The process should determine the parameters under which the computerized system must operate to yield the desired outputs.
The manufacturer of the system hardware usually provides some required specifications for the intended environment (such as temperature and humidity ranges, voltage maximums and minimums, etc.), but these should be used only as a start for your planning.
Your operating environment likely will be different from the system manufacturer’s ideal environment (factoring in things such as dust, need for disinfection, cleaning cycles, etc.). Furthermore, your operating parameters should be specific for your unique use.
For example, is the system used for batches or continuous flow? Will there be long-term storage between uses?
In summary, the manufacturer (you) are responsible for establishing limits for the operating environment and then monitoring the environment so those limits are not exceeded.
Plan to establish, monitor and document tools such as programmed limits, warnings, alarms, and operator training to demonstrate to FDA that you are in control of the operating environments of your computerized systems.
Answered by Martin Browning, President and Co-Founder of EduQuest, who served as an expert field investigator, Special Assistant to the Associate Commissioner for Regulatory Affairs, and co-author of 21 CFR Part 11 during his 22-year career at FDA. Martin is the chairman and co-instructor of EduQuest’s FDA Auditing of Computerized Systems and Part 11/Annex 11 Compliance training class, originally developed at FDA’s request to train Agency field personnel and now in its 22nd year of training industry professionals worldwide.