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

+1-303-443-7100

 

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

Search

  • Linkedin
  • Twitter
Particle Measuring Systems
Without measurement there is no control
Get a Quote
  • Home
  • Particle Counters
    • Airborne Particle Counters
    • Liquid Particle Counters
    • Microbial Samplers
      • BioCapt®Certificates of Analysis
    • Compressed Gas Particle Counters
    • Molecular Monitors
    • Environmental Monitoring Systems
  • Education
    • Knowledge Center
      • Papers
      • Webinars
      • Videos
      • Beginner Guide
    • Particle College
    • Training Services
    • Blog
  • Applications
    • Industries
      • Pharmaceutical
      • Semiconductor
      • Photonics & Optics
      • Aerospace
      • Cosmetics & Personal Care
      • Food & Beverage Safety
    • Annex 1
    • ISO 14644
    • 21CFR 11
    • ISO 21501-4
    • USP 788
    • USP 797
    • Continuous Viable Monitoring
    • Parts Cleanliness Testing
  • Services and Support
    • Product Calibration & Service
    • FMS/EMS Project Management
    • Contamination Control Advisors
    • Hardware & Software Support
    • Customer Service
  • About PMS
    • About Us
    • Contact Us
    • Why Choose PMS
    • Executive Team
    • Careers
    • Corporate Responsibility
    • COBE
    • Parent Company
    • Press Releases
    • ISO Registrations & Quality Policy
    • Trademarks & Patents
    • Anti-Slavery
    • Export Compliance
News Blog
November 25, 2019 02:00 PM

Electronic Data in Pharmaceutical Manufacturing: Rapid Response to Deviation Events (Series Part 4 of 6)

Written by PMS

Rapid Response to Deviation Events

The creation of risk assessment documentation is a basic requirement for implementing a monitoring plan, and rapid response to deviation events is expected. ISO 14644 requires manufacturers to create and use a risk assessment document as a tool to correctly understand the Risk Assessment and Action/Alert setting processes. The determination of action and alert limits, as well as the definition of sampling point location, is extremely important. This must be supported by the Risk Assessment as well as historical sampling data and monitoring controls.

Response to and CAPA (Corrective Action Preventative Action) activities around deviation events must be swift. However, this quick action requires an understanding of the baseline operations of the environment and knowledge of what led up to the event. In the past, much of this fell to the experience and wisdom of available cleanroom owners and operators. Today, automated data collection, analysis and trending removes human bias and makes this decision making more precise and effective, and much less time consuming.

 

Click here to learn more about an innovative and paperless approach

to Cleanroom Monitoring & Data Integrity: PharmaIntegrity

 

See links to additional supporting resources below:

Application Note: Particle Data Collection and Interpretation for ISO Cleanrooms

Application Note: Understanding ISO Standards: ISO 14644-2:2015 Cleanroom Monitoring

On-Demand Webinar: USP 1116 and its Implications for Measuring Microbial Recovery Rates

Application Note: Webinar FAQ – USP 1116 and its Implications for Measuring Microbial Recovery Rates

 

Want to read more? Jump to other released posts in this series:

Part 1 of 6: Data Integrity

Part 2 of 6: Paperless Reporting

Part 3 of 6: Secure Data Transfer 

Part 5 of 6: Reducing Operator Error

Part 6 of 6: Real-Time Microbial Monitoring

Don’t miss an episode of this series. Register for updates on the right column of this page.

Click here to contact our experts for questions.

 

Filed Under: Particle Knowledge

Archives

  • January 2021 (3)
  • December 2020 (3)
  • November 2020 (7)
  • September 2020 (4)
  • August 2020 (1)
  • July 2020 (3)
  • June 2020 (3)
  • May 2020 (6)
  • April 2020 (13)
  • March 2020 (2)
  • February 2020 (5)
  • January 2020 (2)
  • December 2019 (2)
  • November 2019 (4)
  • October 2019 (6)
  • September 2019 (3)
  • August 2019 (3)
  • July 2019 (2)
  • June 2019 (1)
  • May 2019 (4)
  • April 2019 (1)
  • March 2019 (3)
  • February 2019 (2)
  • January 2019 (2)
  • September 2018 (1)
  • July 2018 (4)
  • June 2018 (1)
  • April 2018 (2)
  • March 2018 (2)
  • February 2018 (1)
  • January 2018 (2)
  • November 2017 (11)
  • October 2017 (9)
  • September 2017 (9)
  • August 2017 (1)
  • March 2017 (1)
  • January 2017 (1)
  • November 2016 (1)
  • August 2016 (1)
  • May 2016 (1)
  • March 2016 (2)
  • February 2016 (9)
  • January 2016 (1)
  • July 2015 (1)
  • June 2015 (3)
  • May 2015 (1)

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters for Chemical and Water Particle Monitoring Applications
  • Microbial Samplers
  • BioCapt®Certificates of Analysis
  • Compressed Gas Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Knowledge Center

  • Particle Counting Education
  • Particle College – Electronics Industry Focused
  • Contamination Monitoring Videos
  • Blog

About Us

  • Contact Particle Measuring Systems
  • Why Choose Particle Measuring Systems
  • Particle Measuring Systems’ Executive Team
  • Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • ISO Registrations & Quality Policy
  • Trademarks & Patents
  • Anti-Slavery
  • Export Compliance

Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
E. [email protected]

Keep in touch! Receive industry news from us:

Products

  • Aerosol Particle Counters
  • Liquid Particle Counters for Chemical and Water Particle Monitoring Applications
  • Microbial Samplers
  • BioCapt®Certificates of Analysis
  • Compressed Gas Particle Counters
  • Molecular Monitors
  • Software / Data Management

Industries

  • Pharma
  • Semi
  • Photonics & Optics
  • Aerospace
  • Particle Measurement for Industrial Manufacturing

Applications

  • ISO 14644
  • ISO 21501-4
  • USP 797
  • Meet USP 788 Particulate Matter in Injections
  • Parts Cleanliness Testing
  • Annex 1 Latest Draft Revision Updates
  • 21CFR 11

Service & Support

  • Advisory Service
  • Product Calibration and Service
  • Customer Service

Education and Training

  • Knowledge Center
  • Particle College – Electronics Industry Focused
  • Software / Data Management
  • Blog

About Us

  • Contact Particle Measuring Systems
  • Why Choose Particle Measuring Systems
  • Particle Measuring Systems’ Executive Team
  • Careers
  • Corporate Responsibility
  • COBE
  • Parent Company
  • Press Releases
  • ISO Registrations & Quality Policy
  • Trademarks & Patents
  • Anti-Slavery
  • Export Compliance

Particle Measuring Systems- USA

Corporate Headquarters
5475 Airport Blvd.
Boulder, CO 80301

T. +1 303-443-7100
F. +1 303-440-1090
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