21 CFR Part 11: Data Integrity and Compliance

The Code of Federal Regulations Title 21, Part 11 applies across a range of regulated industries including pharmaceuticals, biologics, medical devices and food products (human and veterinary). Companies in these segments doing business in the U.S., providers of raw materials and components to pharmaceutical companies and contract labs commissioned to perform analysis work must all operate to ensure electronic records and electronic signatures are trustworthy and reliable. 

21 CFR Part 11 Resources

Document Title Category Language Document Type
Particle-qbd01200-brochure-total-organic-carbon-analyzer_revised
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QbD1200
Particle-toc-analyzer-pat-700-21-cfr-part-11-whitepaper0817
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English
Whitepapers
particle-quality-control-21-cfr-part-11-electronic-201806
{442DF88C-CA7F-4B78-AF75-9D2B985534C0}|{E588CF40-730C-4137-A5DC-8DDEAB7CF7D9}
English
PART-2890WP-Optimizing-Workflow-Efficiency-MET-ONE-Whitepaper
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MET ONE 3400 Series, Portable Air Particle Counters, Air Particle Counters, Remote Air Particle Counters
Application Notes
Particle-infographics-alcoa-plus-back-table-04_2020
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Vi-CELL BLU, Vi-CELL MetaFLEX, Multisizer 4e, LS 13 320 XR, MET ONE 3400 Series, Facility Monitoring Systems, HIAC 9703+, ANATEL PAT700, QbD1200
Particle-datasheet-data-integrity-alcoa
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Vi-CELL BLU, Vi-CELL MetaFLEX, MET ONE 3400 Series, HIAC 9703+, ANATEL PAT700, QbD1200, LS 13 320 XR, Multisizer 4e
English
quality-control-gmp-manufacturing-qc-products-final-04_02
{A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}
Vi-CELL BLU, Vi-CELL MetaFLEX, ANATEL PAT700, QbD1200, LS 13 320 XR, MET ONE 3400 Series, Facility Monitoring Systems, MET ONE 6000, MET ONE 6000P, MET ONE 7000, HIAC 9703+, Multisizer 4e
English
Cleanroom Monitoring FDA Guidance 21 CFR Data Integrity
{442DF88C-CA7F-4B78-AF75-9D2B985534C0}
Air Particle Counters, MET ONE 3400 Series, Facility Monitoring Systems
21 CFR Part 11 Data Integrity for On-line WFI Instruments
{442DF88C-CA7F-4B78-AF75-9D2B985534C0}
ANATEL PAT700, TOC Analyzers
English
Leveraging Vi-CELL MetaFLEX for Monitoring Cell Metabolic Activity
{442DF88C-CA7F-4B78-AF75-9D2B985534C0}
Vi-CELL MetaFLEX
Terms and Acronyms
Automating Biopharma Quality Control to Reduce Costs
{442DF88C-CA7F-4B78-AF75-9D2B985534C0}
Vi-CELL XR, Cell Analyzers, MET ONE 3400 Plus, Air Particle Counters, Portable Air Particle Counters, Remote Air Particle Counters, HIAC 9703+, TOC Analyzers, ANATEL PAT700
Optimizing workflow efficiency cleanroom
{442DF88C-CA7F-4B78-AF75-9D2B985534C0}
Air Particle Counters, Portable Air Particle Counters, Remote Air Particle Counters, MET ONE 3400 Series, Facility Monitoring Systems
Quality Control Records 21 CFR Part 11
{442DF88C-CA7F-4B78-AF75-9D2B985534C0}
MET ONE 3400 Series, Air Particle Counters, HIAC 9703+
particle-automating-biopharma-quality-control-wp-201905C
Whitepapers
manual-automated-infographic-qc-pdf-201907
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ANATEL PAT700, HIAC 9703+, LS 13 320 XR, MET ONE 3400 Series
English
Scope and Application