21 CFR Part 11 - Data Integrity
The Code of Federal Regulations Title 21, Part 11 applies across a range of regulated industries including pharmaceuticals, biologics, medical devices and food products (human and veterinary). Companies in these segments doing business in the U.S., providers of raw materials and components to pharmaceutical companies and contract labs commissioned to perform analysis work must all operate to ensure electronic records and electronic signatures are trustworthy and reliable.
Understanding 21 CFR Part 11
FDA ALCOA Guidance
The FDA use the acronym ALCOA to define good data integrity practice to help technicians stay compliant with 21 CFR Part 11.
Terms & Acronyms
Understand the basics of 21 CFR Part 11 data integrity with this glossary of terms.
Products
Explore the suite of Beckman Coulter Life Sciences instruments designed to help you remain compliant with 21 CFR Part 11.
Scope & Applications
Learn about the impacts and requirements for cleanroom operators with process, production and/or quality systems.
Global Equivalents and Related Regulations
Although 21 CFR Part 11 is a United States-based standard, there are similar regulations in numerous countries. Click through to learn more.
Improve the Integrity of your Electronic Records
Cleanroom operators face a unique set of challenges relative to standard operating procedures (SOPs) and particle counting equipment.
