• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

+41 79 261 67 41

  • Youtube
  • Linkedin
  • English / CH
    • 中文
    • 台灣
    • Singapore
    • Denmark
    • English
    • Français
    • Français / CH
    • Deutsch
    • Deutsch / CH
    • Deutsch / AT
    • Italiano
    • 日本語
    • 한국어
    • Português, Brazil
    • Español
Newsletter

Search

Particle Measuring Systems
Without measurement there is no control
Get a Quote
  • Home
  • Products
    • Air
    • Liquids
    • Microbial Samplers
      • BioCapt®Certificates of Analysis
    • Compressed Gases
    • Molecular
    • Software / Data Management
  • CAS Clean Air Services
    • Cleanroom Measurement Services
      • Smoke Studies
    • Thermal Validation
  • Education
    • Knowledge Center
      • Particle Counting Education
      • Beginner Guide to Particle Counting
      • Contamination Monitoring Videos
      • Webinars – Archived
    • Blog
  • Applications
    • Industries
      • Hospital Regulatory Compliance Services
      • Pharma
      • Cosmetics & Personal Care
      • Aerospace
      • Photonics & Optics
      • Semi
    • ISO 14644
    • ISO 21501-4
    • USP 797
    • USP 788
    • Parts Cleanliness Testing
    • Annex 1
    • 21CFR 11
  • Service and Support
    • Product Calibration & Service
      • Balometers
      • Anemometers
    • Project Management
    • Advisory Services
    • Hardware & Software Support
    • Customer Service
  • About Us
    • Contact Particle Measuring Systems
    • Why Outsource With CAS
    • Why Choose US
    • Credibility & Registrations
    • Careers
    • Executive Team
    • Press Releases
    • Corporate Responsibility
    • COBE
    • About Spectris
    • Trademarks & Patents
    • Anti-Slavery
    • Export Compliance
21 CFR Part 11 and Data Management for Data Integrity

Paper: Understand & Comply with GMP & FDA Data Integrity Requirements

This data integrity paper, “Understanding and Becoming Compliant with GMP and FDA Requirements”, discusses data  (such as environmental monitoring data or data from personnel) requirements and management. After reading this paper you will better understand 21 CFR Part 11 data requirements including data management and electronic signatures.

Data Integrity

Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which in turn ensures the product’s quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept. The importance of record-keeping in drug manufacturing can be seen as far back as 1938, when the Federal Food, Drug, and Cosmetic (FDC) Act required the safety of new drugs be documented before being sold to the public, with similar regulations instigated in Europe and Japan throughout the 20th century.
.
Production systems have large, inherent operational risks and are difficult to validate. Instead of only being reactive to public health disasters, preventative measures, such as the requirement for proof of claims, are taken to lower their likelihood and propagate confidence in manufacturers.

Read this paper to learn about 21 CFR Part 11 data integrity requirements. The document is divided into three parts:

  1. General Provisions
  2. Electronic Records
  3. Electronic Signatures

Interested in learning more?
Complete the form to get the full paper.

Particle Measuring Systems (PMS) has complete cleanroom contamination control solutions for you including:

  • Our Contamination Control Advisory Services who can conduct a Risk Assessment for your pharmaceutical processes
  • PMS Cleanroom particle counters including portable/mobile and fixed/remote
  • Microbial Monitors including portable/mobile, fixed/remote, and single use.
  • Data management software from Particle Measuring Systems

Particle Measuring Systems is direct in every major market and able to ensure the same ongoing support no matter where you are located. Contact us today for a quote.

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Molecular Monitors
  • BioCapt®Certificates of Analysis
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Contamination Monitoring Solutions for the Photonics & Optics Industry
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Service & Support

Knowledge Center

  • COBE
  • Contact Particle Measuring Systems

About Us

  • COBE
  • Contact Particle Measuring Systems

Particle Measuring Systems EN-CH

Reinluftweg 1
9630 Wattwil, Switzerland

T: +41 79 261 67 41
E: [email protected]

Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters
  • Microbial Samplers
  • Molecular Monitors
  • BioCapt®Certificates of Analysis
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Contamination Monitoring Solutions for the Photonics & Optics Industry
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Applications

  • ISO 21501-4
  • USP 788
  • Parts Cleanliness Testing

Service & Support

Education and Training

  • Knowledge Center

About Us

  • COBE
  • Contact Particle Measuring Systems

Particle Measuring Systems- EN/CH

Reinluftweg 1
9630 Wattwil, Switzerland

T: +41 79 261 67 41
E: [email protected]

Keep in touch! Receive industry news from us:

  • Website Disclaimer
  • Third Party Privacy Notice
  • Privacy Policy
  • Legal

© Copyright 2021 - Particle Measuring Systems is a Spectris company