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Memmert FDA Conform Software Atmocontrol FDA Edition Comply to Demand of Guideline 21 CFR Part 11 of US Food and Drug Administration

Brand:Memmert

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Description
FDA conform software AtmoCONTROL meets the requirements for the use of electronically stored data sets and electronic signatures acc. Regulation 21 CFR Part 11 of the US Food and Drug Administration
Type
FDAQ1
UNSPSC
41104512

NZ $2960.74

Inc. GST

Available soon

Product description

The Memmert FDA Conform Software Atmocontrol FDA Edition is specifically designed to meet the stringent requirements of FDA Guideline 21 CFR Part 11. This software ensures compliant electronic record keeping and electronic signatures, facilitating regulatory adherence in laboratory and industrial environments. Trusted by Memmert, this edition supports secure data management and audit trails, essential for quality assurance and validation processes.

Key Features:

  • Brand: Memmert
  • Compliance: Meets FDA Guideline 21 CFR Part 11 requirements
  • Functionality: Electronic record keeping and electronic signatures
  • Application: Suitable for labs and industries requiring FDA compliance
  • Security: Provides audit trails and secure data management

This software is crucial for organizations aiming for FDA-compliant process validation and documentation.

Downloads

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FDA conform software "AtmoCONTROL FDA-Edition" comply to demand of guideline 21 CRF PART11 of US Food and Drug Administraion

Manufacturer P/N

FDAQ1

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Manufacturer

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Description

FDA conform software AtmoCONTROL meets the requirements for the use of electronically stored data sets and electronic signatures acc. Regulation 21 CFR Part 11 of the US Food and Drug Administration

IQ/OQ-Document with cabinet related factory data for one free choosable temperature- moisture- and light value, for HPP

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Part Number

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Description

IQ/OQ document with works test data for chamber, incl. temperature distribution survey for one free-selectable temperature, humidity and light value. 27 measuring points to DIN 12880:2007-05, PQ check list as support for validation by customer

IQ/OQ document, incl. temperature distribution survey for 27 measuring points to DIN 12 880: 2007-05 for HPP

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D00136 HPP

Part Number

6.266 308

Manufacturer

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Description

IQ/OQ document with works test data for chamber, incl. temperature distribution survey for one free-selectable temperature and humidity value. 27 measuring points to DIN 12880:2007-05, PQ check list as support for validation by customer

IQ-document with works test data for chamber OQ/PQ-check list as support for validation by customer for HPP

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D00124 HPP

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IQ document with works test data for chamber

Light module cold white 6.500K LED light border, for HPP260 / IPP260

Manufacturer P/N

T7 HPP/IPP/260

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9.868 025

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Description

Light module cold white 6.500 kelvin

Light module cold white 6.500K + warm white 2.700K LED light border, for HPP400 / HPP750 / IPP410 / IPP750

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T8 HPP/IPP/410/7

Part Number

9.868 029

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Light module cold white 6.500 kelvin + warm white 2.700 kelvin

Light module cold white 6.500K LED light border, for HPP750 / IPP750

Manufacturer P/N

T7 HPP/IPP/750

Part Number

9.868 026

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Description

Light module cold white 6.500 kelvin

Light module cold-white 6.500K LED light border, for HPP110 / IPP110

Manufacturer P/N

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Part Number

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Manufacturer

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Description

Light module cold white 6.500 kelvin

Light module cold white 6.500K + warm white 2.700K LED light border, for HPP260 / IPP260

Manufacturer P/N

T8 HPP/IPP/260

Part Number

9.868 028

Manufacturer

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Description

Light module cold white 6.500 kelvin + warm white 2.700 kelvin

Light module cold white 6.500K + warm white 2.700K LED light border, for HPP110 / IPP110

Manufacturer P/N

T8 HPP/IPP/110

Part Number

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Manufacturer

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Description

Light module cold white 6.500 kelvin + warm white 2.700 kelvin

Frequently asked questions

It is specifically designed to meet the stringent requirements of FDA Guideline 21 CFR Part 11. This software ensures compliant electronic record keeping and electronic signatures, facilitating regulatory adherence in laboratory and industrial environments. Trusted by Memmert, this edition supports secure data management and audit trails, essential for quality assurance and validation processes.

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NZ $2960.74

Inc. GST