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Showing posts from November, 2025

EUC Annex 22 on AI & CIMCON Software

  This annex outlines guidance for using AI/ML models in GMP manufacturing of medicines and active substances. It applies to static, deterministic models used in critical applications, excluding dynamic, probabilistic, and generative AI like LLMs. Visit:  https://part11solutions.com/euc-annex-22-on-ai/

21 CFR Part 11 Compliance Solution for Access Databases - Cimcon Software

  Access databases play a vital role in GxP applications such as batch records, clinical data, and manufacturing logs. However, without proper controls, they risk data integrity issues. To meet FDA requirements, Access databases must be fully 21 CFR Part 11 compliant. Visit:  https://part11solutions.com/einfotree-access-module/

Effective Document Controls to Reduce Errors and Enhance Accuracy

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  In today's fast-paced business environment, organizations rely closely on documentation to manage methods, ensure compliance, and make important choices. From complex engineering specs and financial reviews to standard running approaches (SOPs) and customer contracts, the accuracy of these files is paramount. Errors, however minor, can cause substantial consequences-economic loss, regulatory non-compliance, reputational damage, or operational screw ups. This is in which Document Controls -the systematic management of files at some point of their lifecycle-come to be fundamental. Implementing robust and powerful record manage measures isn't just a regulatory necessity; it is a strategic vital for minimizing errors and improving the overall accuracy and integrity of organizational records. Common Causes of Errors in Documents Understanding the root causes of document inaccuracies is the first step toward creating preventative measures. Errors often don't stem from a sin...