Sterisart® Universal Pump | Gen 4

21 CFR Part 11 and EU GMP Annex 11 are critical regulatory frameworks designed to govern the use of electronic records and signatures within the pharmaceutical industry, both aiming to ensure the integrity and security of data. Compliance with 21 CFR Part 11 is crucial, not only for maintaining patient safety and product quality but also for meeting regulatory standards.

Implementing robust electronic record-keeping systems that comply with these regulations allows pharmaceutical companies to enhance data integrity, optimize operations, and facilitate more straightforward root cause analyses and regulatory inspections or audits. This checklist provides a detailed look at the requirements of 21 CFR Part 11 and highlights how the Sterisart® Universal | Gen 4 - Advanced supports your efforts to meet these regulatory demands.