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

Particle Measuring Systems' Software and GAMP® 21 CFR Part 11 Compliance (92.9 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.

Products

Pharmaceutical Facilty Monitoring Software: Pharmaceutical Net

Facility 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 Software

Provides a comprehensive view of batch-based liquid particle counter information with histogram, time plot, and tabular data.

Services

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