New Variant of The Retro-Printer (Retro-Printer-C)

We are currently working with a well-respected controls engineering company to develop a new variant of the Retro-Printer Module, specifically designed for the secure industrial market.

Retro-Printer-C Module

This variant, known as the Retro-Printer-C is no longer dependent on the Raspberry Pi and meets customer requirements to be compliant with the FDA 21 CFR Part 11, established by the US Food and Drug Administration (FDA) to ensure the authenticity, integrity, and confidentiality of electronic records and electronic signatures.

Due to the reliance on the Raspberry Pi (running Linux), the existing Retro-Printer design does not meet the requirements of the FDA CFR, which insists that both closed and open systems must have controls and procedures to ensure electronic records’ authenticity, integrity, and, when appropriate, confidentiality.

These procedures and controls must include the following:

  • Validate systems to ensure accuracy, reliability, and consistent performance.
  • Produce complete and accurate copies of records for review and copying by the FDA.
  • Retrieve records accurately and easily throughout the retention period.
  • Limit system access to authorized personnel.
  • Secure, computer-generated, and time-stamped audit trails.
  • Operational system checks to enforce the correct sequence of steps and events.
  • Authority checks to ensure only authorized individuals have access to the system, can electronically sign records, alter records, or perform the operation at hand.
  • Device checks to verify the source of data input or operational instruction.
  • Controls over systems documentation, including adequate distribution, access, and use of system operation and maintenance documents.
  • Documents need to contain Electronic signatures must include an individual’s name, date, time, and meaning of the signature.

The Retro-Printer-C is therefore designed to act as an interface between the original equipment and a customer’s existing IT systems.  It does not store any of the incoming data, or modify it in any way, and sends it direct by USB to a Windows based computer.

The hardware and communications protocol has already been designed and is currently undergoing testing.

We will then need to re-create our numerous printer emulators to run as a Windows program to interpret the captured data and re-create the original printed image.

The more observant amongst you may have noticed that there is an apparently large empty space on the Retro-Printer-C board.  This is designed to allow a WiFi module to be fitted which will enhance the Retro-Printer-C by making it part of the Blu POP universe range of IoT devices, which allow for the devices to announce their current status and other information to a remote distributed SCADA system for monitoring a large number of the Retro-Printer-C modules.

For example, if you have a factory with several pieces of equipment running Retro-Printer-C modules, the SCADA could be used to see whether the devices are powered on, printing reports, or possibly sending error states via the parallel port.