Logbooks and "other evidence"

[Doug F]

Personally, I think the FAA was pretty clever in using advisory guidance for this (as it does for many other things) instead of issuing regulations which technology might moot in a month.

All the FAA is saying is, "your electronic records need to meet standards of authenticity. Here are some you can follow as a 'safe harbor.'" Doesn't preclude someone, particularly a company, from looking at other industry standards which accomplish the same thing, perhaps updated ones that are maybe even better. Pretty standard fare from what I've seen in other regulated industries.

Your prior company? Well that's what compliance counsel or other compliance professionals are for. Not SGOTI.

Agreed on all points. The FDA uses a multi-pronged method to manage red without changing the law.
Law is writer. Reg is created and put out for comment. Comments are reviewed and the reg is tweaked.
The reg is released with a preamble that goes over every comment and the agencies thoughts and intent are defined so we can know the mind of the regulator.
The agency uses a concept of Current Best Practice so as tech or law moves, the agency can hold companies accountable for how the do work.
For highly complex issues they issue Guidance Documents that provide detailed 'why/how/who' directions.
It works pretty well.

 

[GlennAB1]

Any idea if/how the circular might apply to a Depot Repair station? The company I used to work for did a bunch of work for both military and civilian companies and manufactured stuff that went into aircraft (everything from altimeters to FLIR systems for FedEx). Would records associated with repair (as opposed to maintenance) be in scope? I am not familiar with the FAA regs that drove the company's paperwork trail so I'm just looking for some general feedback.
Thanks for anything you can provide.

Your company would have it written into their Repair Station Manual, as my company has it written into the General Maintenance Manual.

 

[Doug F]

Your company would have it written into their Repair Station Manual, as my company has it written into the General Maintenance Manual.

Good to know. If they ask, I'll point them that direction. I only interacted with the civil aviation (and military) sides of the business a bit and spent most of my time on medical device stuff. I drove them nuts with FDA regs related to eRecords/eSigs because, at the time, the FAA had no position on them. Gonna be interesting to see how they react to this AC...almost wish I wasn't retired!