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Products
Analytical Instruments
Elemental Analyzers
Digestion Units
Distillation Units
Solvent Extractors
Fiber Analyzers
Dietary Fiber Analyzers
Oxidation Stability Reactor
Consumables
Laboratory Equipment
Magnetic Stirrers
Heating Magnetic Stirrers
Heating Plates
Overhead Stirrers
Vortexers and Shakers
Dispersers
COD Thermoreactors
BOD and Respirometers
Cooled Incubators
Flocculators
Turbidimeter
Open Circulating Baths
Pumps
Industries
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
Incubation
Stirring
Stirring & Heating
Mixing & Shaking
Dispersing
Vacuum Generation
Turbidity
Trace Determination of Heavy Metals
Knowledge
News
Newsroom
Webinars
Trainings and Workshops
Exhibitions
Download Area
Brochures & Leaflets
Instruction manuals
Comparison tables
Application notes
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Resources and insights
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Dumas Method
International Standards
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Service
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Accessories
>
21 CFR part 11 package for Elemental Analyzers
21 CFR part 11 package for Elemental Analyzers
Additional software package for elemental analysis in accordance with FDA regulations.
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21 CFR part 11 package for Elemental Analyzers
A00000455
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Description
Description
Models
Products
Achieve compliance to 21 CFR Part 11 provisions for elemental analysis
21 CFR Part 11 Package upgrades the
software
of
Elemental Analyzers
for Pharmaceutical, Cosmetic, and Food industry laboratories that require compliance with FDA regulations.
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
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CN 802
cod. F30800090
EMA 502 CHNS-O Elemental Analyzer
cod. F30800100
NDA 702 Dumas Nitrogen Analyzer
cod. F30800080