[change country]- 21 CFR 1271 for Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P)
- 21 CFR Part 11 Compliance
- Airborne Particle Counters
- DI Water / UPW Particle Monitoring
- GAMP® Requirements and Solutions
- GMP and cGMP Particle Counting Requirements for EU and FDA Regulations
- ISO 14644 Cleanroom Classes for Particle Monitoring
- ISO 21501: Determination of Particle Size Distribution
single particle light interaction methods - ISO Cleanroom Class Particle Monitoring
- ITRS Roadmap Solutions
- Microbial
- Monitoring Particles in Injectables for USP 788 and EP6
- NEW INFORMATION GUIDES
- NEW INFORMATION GUIDES
- Optical Haze Blurs the Bottom Line
- Particle Counters for Gas Applications
- USP 797 Particle Monitoring Solutions
- WET PROCESS CONTROL
- processcontrols
21 CFR Part 11 Compliance
Particle Measuring Systems has been involved with meeting 21 CFR Part 11 since its introduction in 1997. Please read below the papers on our current compliance to the legislation relating to Electronic Signatures and Electronic Records (ESER).
Papers
|
Facility Sight 21 CFR Part 11 Compliance (110.0 KB) Pharmaceutical companies have historically submitted product applications to the Food and Drug Administration (FDA) on paper. With the advent of technology this is now dominated with electronic data records and electronic submissions. This change in philosophy has meant that in the FDA's... Download above file for full tables and figures, or for overview, see HTML Version. |
|
FDA Paper Review on 21 CFR Part 11 (580.3 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
Products
 |
Pharmaceutical Facilty Monitoring Software: Pharmaceutical NetFacility monitoring software that helps you meet your cGMP requirements, providing simplified validation and compliance to 21 CFR Part 11. Helps you to analyze data from your particle counters. |
 |
SamplerSight Particle Monitoring SoftwareProvides a comprehensive view of batch-based liquid particle counter information with histogram, time plot, and tabular data. |
Services
Particle Counter Rental / Leasing OptionsIf you need a particle counter or molecular contamination monitor for a short-term project or troubleshooting, we offer a comprehensive rental program. |
 |
Pharmaceutical Microcontamination Monitoring ServicesWe have managed over 150 fully integrated system projects worldwide in a variety of applications including: aseptic, tableting, powder fill, and medical devices. |
Information on this website is subject to change without notice.
