The problem is that the current versions of the Retro-Printer use an in-built Raspberry Pi to take the captured data and process it, storing it on the mico SD card and then emulating the original printer.
Unfortunately, this 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.
Unfortunately, the Raspberry Pi does not meet these requirements - particularly the limitations on access to the system and logging access.
We are therefore looking at a complete redesign in conjunction with our long-term controls partner (MJ Controls Limited) which will meet these industry requirements and be part of their Blu Pop range of IOT devices, with the printer emulation running on the customer's secured PC