We use cookies to improve your experience. By your continued use of this site you accept such use. Read more about cookies here. ACCEPT Modules All USP 1/2/5/6 Modules Baths Media Stations Pumps Filter Stations Handling Stations Sample Collectors Cleaning Stations Analytical Devices Analytical Devices Specord® UV-Vis High performance double beam photospectrometer with CDD. UV7 UV-Vis Compact and fast diode array photospectrometer for UV Online. HPLC / UPLC Direct injection into HPLC / UPLC liquid chromatography systems. Request a QUOTE Campus Contact us NEED SUPPORT? REQUEST A QUOTE TEAMVIEWER © SOTAX All rights reserved.

We use cookies to improve your experience. By your continued use of this site you accept such use. Read more about cookies here. ACCEPT 21 CFR part 11 Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)). Practically speaking, Part 11 applies to drug makers, medical device manufacturers, biotech companies, biologics developers,CROs, and other FDA-regulated industries, with some specific exceptions. It requires that they implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data that FDA predicate rules require them to maintain. A predicate rule is any requirement set forth in any FDA regulation other than Part 11, like the Public Health Service Act. Subpart A – General Provisions § 11.1 – Scope § 11.2 – Implementation § 11.3 – Definitions Subpart B – Electronic Records § 11.10 – Controls for closed systems § 11.30 – Controls for open systems § 11.50 – Signature manifestations § 11.70 – Signature / record linking Subpart C – Electronic Signatures § 11.100 – General requirements § 11.200 – Electronic signature components and controls § 11.300 – Controls for identification codes / passwords Request a QUOTE Campus Contact us NEED SUPPORT? REQUEST A QUOTE TEAMVIEWER © SOTAX All rights reserved.