Manufacturing Equipment need 21 CFR 11 Compliance?

Hello all, i’ve recently been given the oppurtunity to join the validation team and was on a FAT for bespoke extruding equipment.
I’d like to ask, and any info would be very grateful, if i have manuufacturing equipment that is pc controlled, (operators can run it, can’t change settings, administrator changes settings etc), does this software need 21 CFR part 11 compliance, if it does not record data that will be used for finished product release?

It does record processing conditions, but as i say, we won’t use these, the raw materials will be QC tested, as is the finished product (i.e a proprtionate, sample, and what should the sample size be please?)

I appreciate your help with this, many thanks,


Computers are used extensively throughout the industry in automatic and semi-automatic equipment to sequence events and actions. Where these events and actions do not generate data that is required to be submitted to the regulators (on demand or at a routine review), otherwise called predicate data. 21 CFR Part 11, is not applicable. The functions of the equipment and computer will be validated in the execution of the IQ/OQ/PQ. Similarly the computer application software is subject to separate GMP requirements as to its use, storage and accessibility.

Once more the FDA guidance on 21 CFR Part 11, enforcement has been re-hashed. The regulators have eased the burden in some respects, by accepting quite a few previously proscribed practices. However there is a new requirement that requires a written justification for the method of storing each and every record that is categorised as predicate data.

The requirement is for a written (documented) procedure on the storage of regulatory required data (predicate), along with details of how, your company is currently storing all such data. In return they will be much more agreeable to the use of none compliant Part 11 systems, for storage of predicate data. We are in the process of producing an SOP for these requirements; it will be ready and available within the next week.

Alex Kennedy

Very simple and powerfull explanation!!! Many thanks Alex!!!



guys i would need the ac line that goes from the compressor to the reciever. It has 2 lines on it. The part where it goes to the compressor snapped today.

anyone hae the part nuymber?