Two people looking at an ApexZ that has Data Integrity written across the screen.
Mar 1, 2023

What Happens When You Fail To Meet FDA Data Integrity Standards

We talk a lot about data integrity, but what happens, in the real world, when US Food and Drug Administration (FDA) data integrity protocols are not met? In December, we got to see this scenario play out. Between November 22, 2022 and December 2, 2022, FDA inspectors visited a large pharmaceutical manufacturer’s facilities in India […]

Sep 22, 2022

Cleanroom Validation from URS to PQ; ISPE GAMP5 2022 Edition & V Scheme Application for Cleanroom Monitoring Systems

Jun 30, 2022

What is 21CFR11 and why is it so important in maintaining Data Integrity?

Jun 16, 2022

21 CFR part 11 Overview

21 CFR Part 11 outlines the federal requirements that help to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. 21 CFR Part 11 has 10 chapters over 3 subsections. These subsections are General Provisions, Electronic Records, and Electronic Signatures.

Apr 21, 2022

Best Practices in Particle Counter Management To Increase Data Integrity Reliability

Particle Counter management is a critical process in ensuring particle counter health and data integrity. The accuracy of the data from particle counters is critical in regulated industries. Particle Counters should be calibrated regularly based on their use. Manufacturers recommend that Particle Counters are calibrated at a minimum on an annual basis.

Dec 21, 2021

Digitalize Your Environmental Monitoring Contamination Control Strategy

Data Integrity
Jul 23, 2021

Data Integrity in Environmental Monitoring

Features to look for in your particle monitor to ensure compliance of your cleanroom Environmental monitoring lies at the heart of regulatory compliance for cleanrooms used in pharmaceutical, bio-pharmaceutical, and healthcare facilities. Facility managers need to understand what components are needed for a monitoring program, but they must also ensure the data they produce is […]

Apr 15, 2021

Particle Monitoring- How To Go Paperless in The Cleanroom

Apr 15, 2020

Particle Monitoring – Going Paperless in the Cleanroom