21 CFR Part 11 - Allen Bradley

[hhuong]

Hello All,

I saw couple old posts (back in 2005) that mentioned a little about compliance with 21 CFR Part 11. I am curious if there is any new Allen Bradley products that can easily compliance with this FDA regulation (21 CFR Part 11).

I am currently working on a project with a pharmaceutical company. We will be building an electrical control panel and the customer requested the control panel to be compliance with 21 CFR Part 11. I am still new to this FDA regulation. I was thinking to use Allen Bradley ControlLogix as PLC and Versaview as the local HMI mounted at the front panel door. Then I will install either RsView32 or RsView SE on the Versaview for all the data logging historians and audit trail for electronic signature. Would this configuration be sufficient to meet the requirements of 21 CFR Part 11?

I hope someone who familiar with this can provide me some guidance on these questions. Appreciate it. Thanks

 

[leitmotif]

I think this is a good question to ask someone who is really expert at this. Took a look at it

http://www.21cfrpart11.com/pages/faq/index.htm

and the first question in FAQ seems to make it clear this is a real can of worms to be approached carefully. Think a whole bunch of studying would be needed for this.
Reads like this:
Can a vendor guarantee compliant software for Part 11?

It is not possible for any vendor to offer a turnkey 'Part 11 compliant system'. Any vendor who makes such a claim is incorrect. Part 11 requires both procedural controls (i.e. notification, training, SOPs, administration) and administrative controls to be put in place by the user in addition to the technical controls that the vendor can offer. At best, the vendor can offer an application containing the required technical requirements of a compliant system.



Dan Bentler

 

[DaveW]

Dam is right. It's a can of worm with FDA and the 21CFR Part11 requirements and you really have to be careful which part you quoted and are responsible for. Larger pharmaceutical companies usually employ validation reps that can help you with answers to these requirements.
From your description, I would think you need some sort of physical security for the panel such as a key lock on the panel door and CPU. For the HMI’s, there’s a strict guideline for user accounts such as password minimum length, alphanumeric, expiration, lockout after 3 failed attempts, etc. And as you mention, there needs to be an audit trail setpoints and user actions and relational database for historical data.