21 cfr & autit trail

[jadhavsr]

Dear sir ,

Our one pharma customer having Iris 32 software ver. 2.3 (Int 7 PCI Card) & ver 4.0 (Crolimark USB ).With SST
now they wants working with 21 cfr commplence so regarding i am very difficult to demostrate them.
please suggesst how i can solve the issue .& please give us complete guideline on 21 cfr & audittaril
i am waiting for reply.

[Daniel Mentlik]

Dear Sunil,
your customer will, in any case, need to upgrade his/her software to the newer version to fully support CFR 21 Part 11. As Iris32 software is an OEM made for Chemito company (now part of Thermo), the upgrade has to be processed by your side.

Latest version of Iris 32 software released is 4.0.01.700, which is fully compatible with CFR 21 Part 11. The procedure of how to fulfill all CFR21 Part 11 conditions is fully described in the Clarity in Regulated Environment manual.

As for "ver 4.0 (Crolimark USB)", this does not ring anything familiar with me, and definitely is not DataApex product.

[jadhavsr]

Dear sir ,

Thanks for your reply.

& our customer having two type software

1) Iris 32 sst software ver. 2.3 (Int 7 PCI Card
Please confirm is it competable for 21 cfr ?


2) iris 32 sst ver 4.0.01.700 Colibrick A/D converter, external USB, 1 channel
If this is compebetable with 21 cfr part 11 can please advice how to enable audit trail events .

I am waiting for your reply.

Sunil.

[Daniel Mentlik]

Dear Sunil,
as stated above, Iris 32 software version 4.0.1.700 is compatible with CFR 21 part 11. For the station in version 2.3, it must be upgraded to 4.0.1 (most probably pricelist item C600 if the station currently does not have HW key).

The setting to comply with CFR 21 Part 11 is far from trivial and contains a lot of steps done outside of Clarity (Iris 32) too, but everything is closely described in the above-mentioned Clarity in Regulated Environment manual. Follow all the procedures described there, please.