21 CFR 211

AssurX offers robust solutions for compliance with 21 CFR 211, ensuring pharmaceutical manufacturers meet FDA regulations for drug product quality. Our platform streamlines processes, enhances record-keeping, and supports operational excellence to maintain compliance with Good Manufacturing Practices (GMP).

17 03, 2022

Remote Quality Audits for Regulated Companies Come of Age

By |2025-01-01T00:01:28+00:00March 17th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

This article is part one of a two-part series focused on GMP quality audit mana [...]

24 02, 2022

Trend Watch: 2022 and Beyond Will see Maturation of Internal Control Programs

By |2024-07-16T22:55:59+00:00February 24th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Technology, Politics, Climate, and the Coronavirus will Drive Maturation of Int [...]

9 12, 2021

3 Essential Document Control Best Practices for Combination Products

By |2024-12-31T23:24:07+00:00December 9th, 2021|Document Management, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Combination products (CPs) have revolutionized drug delivery and patient care, b [...]

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