Universal Robots Forum

21CFR11 Compliance

My company works adjacent to the US Pharmaceutical Industry, and they’ve asked me to look into making these devices 21CFR Part 11 compliant. The highpoints of this regulation basically say “Secure your records. Also, keep thorough records” and how’s that been broken down to me makes it sound like I don’t want a URCap, i want to re-write some of these device’s OSs. I’ve been asked to explore the feasibility of the following:

Maintain Usergroups with varying level of permissions. Admins get what we basically have now, access to all. Bottom tier users would not be able to create new programs, load other programs, clear the log, etc. etc. with the bonus requirement being the unavailable buttons being “grayed out”. Admins would also have the ability to change a user’s group and add new users.

What information the log (log tab) keeps is improved, including keeping track of user logins, but also just more information on status changes inside the robot.

For starters i’m asking if this is feasible with a URCap. If not in a URCap, but still kinda possible, with what resource? Finally, if kinda possible, could you point me to some of that resource’s API? I had a look through the API for the URCaps already and that’s what made me think most of this isn’t supported by the resources available to us.

I’m not too familiar with the standard you mentioned, but to your point on varying level of permissions here are some resources you can look into.

As is the UR has the ability to setup a couple passwords. One will be used to make any safety changes on the system, another is used to lock out users from being able to make operational changes to the robot.

The latest E-Series user manual shows more information on setting safety passwords in section 13.1.2. Section 21.3.2 describes setting an operational password to prevent unauthorized modifications of the robot setup.

You can download the manual here.

You can also set these modes up through the dashboard sever depending on how you interface with external equipment. You can see a brief overview here.

Maybe other users have more experience with similar compliance requirements, but these should be a good place to start addressing some of the requirements.

The section 21.3.2 mentions automatic vs manual mode, but i just want to confirm its meaning. When it says “When you set operational mode password, programs or installations can only be created and loaded in manual mode. Any time you enter
manual mode, PolyScope prompts for the password that was previously set on this screen.” it means in automatic mode, changing the program in any way is disabled? Whether it’s loading a different one or changing the current one? If so, would it be possible to change in any way exactly which functions it locks out?

Correct, in automatic mode changing the program in any way through the teach pendant would be disabled, in automatic mode users are restricted to the run, initialize,move, I/O and log tabs.

You will however still be able to load programs through polyscope in automatic mode, if they are stored on the robot, and have the same saved safety settings as the loaded installation file.

2 Likes