AC3006 ROTRONIC, AC3006 Datasheet - Page 2

• Manufacturer Part Number: AC3006
• Description: INTERFACE CABLE, HYGROPALM PC
• Manufacturer: ROTRONIC

Specifications of AC3006

• Rohs Compliant: NA

Qualification / Computerised system validation
Data integrity and security are of essential importance today. Companies in the food, pharmaceutical and medical technology
industries must prove that their data are measured and managed reliably. For this they need software and devices that can be
validated. Combining ROTRONIC's HW4-compatible devices and HW4 software, ROTRONIC supplies a solution in which validation
plays a central role. The devices and software are validated and compatible with FDA 21 CFR Part 11 (directive of the US Food and
Drug Administration, FDA) and GxP.
The HW4 software and devices have been reviewed against the specifications and the ERES White Paper,
version 1.0, in order to provide evidence that the above mentioned regulations are fulfilled accordingly.
The measuring devices and the software have been validated and verified against the specifications provided
by the manufacturer.
We attest that the validated version of the Rotronic HW4 software and associated devices
HygroFlex, HygroFlex M, HygroLab, HygroPalm, M23, M33: firmware release 4.0
Inspected by Yves Samson
EU Guidelines of Good Manufacturing Practice for Medicinal Products
DS-NT4, DS-NT4-WL, DS-U1; DS-U2, DS-U4, DS-U4-4-4-20, DS-U4-WL: v 1.4
fulfil the requirements defined in the Rotronic ERES White Paper, version 2.0,
Kereon AG
Docking stations for the HygroLog NT:
validated by ROTRONIC Instrument Corp.
HygroClip Alarm firmware version 2
HygroLogNT: firmware release 1.2
COMPLIANCE DECLARATION
Hygrostat MB firmware version 1
Sof t ware
HygroClip DI firmware version 1
based on the following paragraphs:
DS-PT2, DS-PT4, DS-PT4-WL: v1.1
DV04-30.787.03-1_11
HW4 version 2.0.1.15990
21 CFR 210, 21 CFR 211
Inspected by Kereon AG,
EU Annex 11 to the
DS-U4WEB : v1.0
Physical devices
21 CFR Part 11
DS-R1 : v1.0
August 2007
21 CFR 110
Software
for
Accepted by the manufacturer
ROTRONIC AG
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