Kalliope in Control: Data Integrity and 21 CFR Part 11 Compliance for Particle Size Analysis
In industrial sectors regulated by the U.S. Food and Drug Administration (FDA), electronic records produced by analytical instruments need to comply with 21 CFR Part 11 regulations. For Litesizer DLS and PSA instruments, compliance is enforced by installing the software Kalliope in the so-called "pharma mode". Here we detail how compliance with 21 CFR Part 11, but also the ALCOA++ principles, is achieved when the pharma mode is activated.
While quality control is essential to all industrial products, all sectors are not held to the same standards by governmental institutions. Wherever production issues can potentially impact human health, stricter rules apply to ensure product safety, efficacy and quality.
Data generated by analytical instruments used in these regulated industries must comply with specific regulations to ensure so-called data integrity. Under this umbrella term, data integrity refers to the accuracy, completeness, and consistency of data throughout the lifecycle of the product. It ensures that electronic records generated during the development, testing, manufacturing, and distribution of e.g. pharmaceutical products are reliable and traceable.
Anton Paar manufactures analytical instruments which are heavily used in the regulated context. Over the years, the company has developed a coherent strategy to ensure the compliance of its instruments and software. Through an internal certification process, the different instruments and their accompanying software are classified into 3 distinct data integrity categories, termed "Standard", "Advanced", and "Excellence" (1).
The software Kalliope, when used in combination with its 21 CFR Part 11 module, can steer Litesizer DLS and PSA series instruments in a compliant manner and, thanks to its enhanced compliance features, has been classified in the "Excellence" category by our internal experts. Here we detail how Kalliope, when installed in the so-called "pharma mode", ensures the data integrity of electronic records.
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