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Analytical Instruments
Elemental Analyzers
Digestion Units
Distillation Units
Solvent Extractors
Fiber Analyzers
Dietary Fiber Analyzers
Oxidation Stability Reactor
Consumables
Accessories
Spare parts
Laboratory Equipment
Magnetic Stirrers
Heating Magnetic Stirrers
Heating Plates
Overhead Stirrers
Vortexers and Shakers
Dispersers
COD Thermoreactors
BOD and Respirometers
Flocculators
Accessories
Spare parts
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Industries
Food, Feed and Beverage
Environmental and Agro
Chemical and Petrochemical
Pharmaceutical and Life Science
Cosmetics and Personal Care
Pulp, Paper and Textile
Commercial Labs
Academia, Research and Government
Applications
Nitrogen/Protein Determination
Carbon Determination
Solvent Extraction
Fiber Determination
Oxidation Stability Studies
BOD and Respirometric Studies
Jar Test & Leaching Test
Chemical Oxygen Demand
Stirring
Stirring & Heating
Mixing & Shaking
Dispersing
Vacuum Generation
Trace Determination of Heavy Metals
Knowledge
News
Newsroom
Webinars
Trainings and Workshops
Exhibitions
Download Area
Brochures & Leaflets
Instruction manuals
Comparison tables
Application notes
Certifications
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Dumas Method
International Standards
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Service
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Installation
Preventive Maintenance
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Enabled Products
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Access to the Platform
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UNITED STATES
(English)
nation:
UNITED STATES
language:
English
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ITALIA
Italiano
UNITED STATES
English
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Accessories
>
21 CFR part 11 package for UDK169-159
21 CFR part 11 package for UDK169-159
Software package upgrade for UDK 159 or 169 distillation units for compliant nitrogen determination according to FDA regulations.
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Contact a specialist
21 CFR part 11 package for UDK169-159
A00000429
Close
Achieve compliance to 21 CFR Part 11 provisions for nitrogen determination
21 CFR Part 11 Package upgrades
UDK 159 or 169 software
for Pharmaceutical, Cosmetic and Food industry laboratories that require compliance with FDA regulation.
The
FDA's Code of Federal Regulations Title 21 Part 11
defines the requirements for using electronic records and electronic signatures on computerized systems. The integrity, reliability, and trustworthiness of electronic records must be fulfilled as for 21 CFR Part 11 basic requirements.
VELP
21 CFR Part 11 Package
helps you achieve full compliance with
Subpart B - Electronic Records
and
Subpart C - Electronic Signatures
of the regulation:
Track and record of settings and any changes to settings
with the system log function running permanently, serving as an audit trail
Track who performs any operation
as analysis results are automatically signed with the user information. Each user has a unique identification and electronic signature
Ensure the quality and incorruptibility of recorded data
with backup procedures. Exported files are protected from unwanted or improper alteration
Ensure the right delegation of responsibilities
at the right level with the user management system with three access levels
Models
Please select the model
UDK 159
cod. F30200155
UDK 169
cod. F30200165
UDK 169 & AutoKjel
cod. S30200165
Description
Description
Models
Product
21 CFR part 11 package for UDK169-159
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