PLC Computer validation

I am looking for a book on PLC computer validation

Ok I'll bite, what is that

PLC means programmable logic controller..ie you program it to control logic.

How does computer validation become involved?

PLC means programmable logic controller..ie you program it to control logic.

Click to expand...

Ok I agree, that is a conundrum, a plc uses a processor similar if not the same as a computer AND a computer controls logic BUT a computer is designed to do more than a plc BUT a plc is designed and proven to do one thing and does it well.

I think you need to be more specific. Validation is normally a process concerning special processes but I guess plc's can be involved.

May want to checkout
http://www.qeval.homestead.com/

Also lookup OSHA, ANSI, ASTM, etc

I look forward to your and others posts on this subject.

Not available in bookstores anywhere

I've never heard of a published one. Every pharamceutical company that I've dealt with has their own standards for PLC validation.

Sometimes they lump them in with "computer validation" (which makes the standards difficult to use, due to the contant references to 'database' and 'audit trail'.

The good ones have separate standards for PLCs, SCADA/HMI, and "computer systems".

But most pharmas are also reluctant to just hand out their standards. I've usually had to sign non-disclosure agreements (once I even had to smuggle a copy out that a manager "didn't let me copy (wink, wink, nod, nod)".

If you find something, please post it. I'd love to be able to have something to reference.

Your best bet for SOMETHING is to buy GAMP (GAMP.ORG) and a copy of 21 CFR (Code of Federal Regulations) from the government. Pay particular attention to parts 210 & 211. Also Part 11 (the new hot topic). GAMP is not cheap. 21 CFR might be a Pueblo, Colorado production and available for a resonable fee (my former boss gave me my copy, so I don't know)

Good luck.