Pharmaceutical manufacturing is a cost-critical market subject to unprecedented regulatory oversight. International and regional bodies establish key directives to control the quality of drugs released to market, primarily to ensure their safety and efficacy. As a result, few industries are required to run quality assurance and control (QA/QC) protocols as stringent, nor at such small scales, as in the pharmaceuticals market. 

Custom Image Analysis & 21 CFR Part 11 Compliance | Clemex

Custom Image Analysis for Research, QA/QC & More

Particle shape and size measurements, on a slide or a filter, are a staple analytical process throughout pharmaceutical development. Using custom image analysis at multiple touchpoints in various types of environment (R&D, QC, GMP, GxP requirements), manufacturers can conduct routine high throughput screening of sample materials at multiple touchpoints in the development chain. Empowering this automated system with advanced user management software can elevate your testing objectives even further.

Custom image analysis with a Clemex user management module guarantees the utmost data integrity, providing access to real-time size and shape data that is not only unalterable but is statistically significant for each particle category. This is an important parameter for meeting crucial pharmaceutical legislature, such as 21 CFR part 11.

What is 21 CFR Part 11?

The Code of Federal Regulations (CFR) is a set of general and permanent rules published within the Federal Register. Title 21 CFR relates to food and drug products, encompassing a set of codifications established by the Food and Drug Administration (FDA). Finally, 21 CFR part 11 encompasses the trustworthiness and reliability of data as analytical processes increasingly move towards digitization – hence its relevance to custom image analysis and digitized particle measurements. Contract researchers, drug makers, medical device manufacturers, and certain biotechnology companies all strive for 21 CFR part 11 compliance for goods released to US markets – but these regulations are also used throughout the world as guidelines for non-US markets.

What Makes Clemex Custom Image Analysis Compliant?

The Clemex PSA is a high-precision tool for specific image analysis of your sample materials. Providing custom, real-time imaging of various particle size and shape parameters with the ability to isolate particles of interest while guaranteeing complete data validation is essential to how we meet and exceed 21 CFR part 11 compliance.

Measure multiple, different-sized particles in a single run and isolate particles of interest based on a wide range of parameters with completely automated validation of measurement accuracy. Custom image analysis software empowers our users to go beyond regulatory compliance, ensuring the quality of results for high throughput digital analysis.

If you would like to learn more about which Clemex custom image analysis solutions offer 21 CFR part 11 compliance as standard, simply contact a member of the team today.