FDA 21 CFR Part 11, by Food and Drug Administration (FDA) of the US government, defines
the criteria under which electronic records and electronic signatures can be treated with
same degree of validity as paper-based records. Since the scope of FDA’s regulatory
authority is very broad, Part 11 has an impact on all computer systems in life science
industry.

The main role of a HMI is to be either one of the following:

• Can act as a Modbus server/OPC UA server that allows the reporting software to retrieve data.
• Can act as a SQL client to transfer history data into a database server that will be accessible to the reporting software.

We have put together a guide aimed at helping users understand how to comply with FDA 21 CFR Part 11 when using Maple Systems HMI. In this document, Part 11 codes are reviewed article by article, in the context of HMI, followed by discussion of related features and configuration options that will help meet the requirements.

If using the system with Maple Systems HMI in regulated environment, users are requested to create and administer their systems according to the guidelines in this document. Users are advised, though, that the requirements for FDA 21 CFR Part 11 apply to the entire project, not just the HMI alone. HMI functions can facilitate compliance regarding electronic data generated by the HMI, but implementing only what is described in this document does not guarantee compliance with FDA 21 CFR Part 11 for the entire setup. Thorough audit of the entire system must be carried out by professionals in the field. Nonetheless, if any electronic data generated on HMI are used, the procedures in this document should be followed.

Download the Maple Systems EBPro & FDA 21 CFR Part 11 Manual