Industrial Internet of Things Appliance

Section 820.70(i) in Production and process controls states:

 

"(i) Automated processes  When computers or automated data processing

systems are used as part of production or the quality system, the

manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented."

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That software includes the following:

• Software used as part of the manufacturing process (including software embedded in machine tools, statistical process control software, programmable logic controllers [PLCs], and software in automated inspection or test systems).

• Software used in process validation (such as statistical calculation software, spreadsheets etc.).

• Software used in design and development processes (such as CAD software, CAM software, software development tools, software test tools, compilers, editors, code generators, etc.).

• Software used to automate part of the quality process (such as complaint-handling systems, lot-tracking systems, training-database systems, etc.).

• Software used to create, transmit, modify, or store electronic records that are required by regulation.

• Software used to implement electronic signatures for documents required by regulation.

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For FDA software validation, it is important to document each item in an Intended Use document along with how it influences the production process. Understanding how each command or function impacts the overall production process, prioritized by risk, lets users take advantage of the follow process-level software validation techniques.

 

A computer would need FDA software validation. It has a general-purpose hard drive with many, accessible applications. FDA software validation typically takes a team several weeks and upwards of $80,000.

 

A "Black-Box" is different. It is an MES gateway appliance dedicated to a specific function. The operating system is integrated with a chipset. It has a single, embedded application. An MES gateway appliance can forgo software validation and still meet FDA requirements.