In 2002 we received the following "Ask the Experts" question from one of our readers and since posting it on our site, along with our experts' answers, there has been a lot of interest from our online community.
Our reader asked:
The technicians and operators in our brewery sometimes change the PLC programs to accommodate maintenance and production requirements. We're concerned that the FDA would take issue with this practice. What should we do to be sure our PLC program management would be accepted by FDA inspectors?
Daren Moffatt, Pharmaceutical Industry Business Manager said that PLC and DCS control system configurations are a topic with many different opinions in the industry with regard to 21 CFR Part 11 compliance. Fifty percent of the companies Moffatt spok with with believed the control configuration is an electronic record and requires the same level of revision control and change tracking as an electronic batch production record. The other 50% agreed that modifications to the control configuration require change control, but did not believe the configuration falls under 21 CFR Part 11 jurisdiction.
"Certainly the PLC or DCS programs are not submitted to the FDA, but they do require validation to ensure proper functionality," said Moffatt.
Michael Burgin also chimmed in and said that there are multiple issues to consider when PLCs are included in the mix of process control strategy and design. Burgin estated that the key element in maintaining the PLC and also maintaining the design baseline is a SOP to determine what constitutes a minor and a major change. Burgin went on and listed 5 steps describing what the process should be like.
Moreover, Gimmi Filice said that the situation described by our reader in his question, was a direct violation of 21 CFR Part 11 although probably not sufficient to warrant a warning by the FDA.
If you want to read these experts' answers in full details and what our other experts had to say, visit our original artile "How Should We Manage PLC Programs to Meet FDA Requirements?" to learn more.