• 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

  • Linkedin
  • Twitter
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
News Blog
November 12, 2019 06:44 PM

Electronic Data in Pharmaceutical Manufacturing: Benefits of Paperless Reporting (Series Part 2 of 6)

Written by PMS

Benefits of Paperless Reporting in Pharmaceutical Manufacturing

Paperless Pharmaceutical Manufacturing

Paperless pharmaceutical manufacturing sites are a relatively new concept. In 2015, ISO updated their Standard 14644 to include data integrity issues that allowed manufacturers to use validated systems to electronically store, analyze and report their product and process data. This was a great benefit to the industry as it gave manufacturers and auditors a template to agree on for accepted standards of electronic data.

In the past, manufacturers were required to have hard copy records as evidence that the environmental conditions for aseptic fill were maintained, these supported the release of a batch. Today, electronic records are becoming more common as manufacturers witness the value and invest in facility monitoring systems that modernize data collection in their facilities. Standard reports required by regulatory inspectors such as: historical reports, exception reports, time plot reports for duration of batch, statistics [Max, Min, Avg, Std Dev, % Alarm, % Conformance] and alarm events are easily handled by facility monitoring system software. To add to their value, these software systems can easily configure this data for facility optimization, Out Of Specification (OOS) analysis and many more quality and engineering operations.

Manufacturers and suppliers alike are anxious to see even more uptake in the direction of “paperless” facilities. Aside from the advantages to the planet, it just makes good business sense.

 

Click here to learn more about an innovative and paperless approach

to Cleanroom Monitoring & Data Integrity: PharmaIntegrity

 

See links to additional supporting resources below:

  1. On-Demand Webinar: The Life Cycle of Big Data in A Contamination Control Strategy
  2. Application Note: Data Integrity: Understanding and Becoming Compliant with GMP and FDA Requirements
  3. Blog/Video: Moving to a Paperless Data Management Solution

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

Part 1 of 6: Data Integrity

Part 2 of 6: Benefits of Paperless Reporting (You are here!)

Part 3 of 6: Secure Data Transfer

Part 4 of 6: Rapid Response to Deviation Events

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: Uncategorized @en-ch

Archives

  • January 2021 (1)
  • December 2020 (1)
  • November 2020 (3)
  • September 2020 (4)
  • August 2020 (1)
  • July 2020 (3)
  • June 2020 (3)
  • May 2020 (6)
  • April 2020 (12)
  • March 2020 (2)
  • February 2020 (3)
  • January 2020 (1)
  • December 2019 (2)
  • November 2019 (3)
  • June 2019 (1)
  • May 2019 (1)

Subscribe to our news feed!

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