(Auditor Option) Record, Manage, Optimize Regulatory Compliance Considerations the US Code of Federal Regulations from the Food and Drug 1 requirements, this data sheet demonstrates how Eurotherm As part of an ongoing commitment to aid compliance to Administration (FDA) and specifically FDA 21 CFR Part 1 domain expertise helps customers meet the various requirements of FDA 21 CFR Part 11.Each subsection considered is listed in the header of the tables below, and the statements within each table are accompanied by a commentary demonstrating how the Eurotherm solution aids compliancee. Sub Part B - Electronic Records

Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Such procedures and controls shall include those identified in Sec. 11.10, as appropriate, and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality. The...

Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means. Signature manifestation is embedded in the binary format history file. For hybrid systems, prints created via Eurotherm Date Reviewer for handwritten signature will always contain timestamp details which permit re-creation from the original data. (a) Each electronic signature shall be unique to one individual and shall not be reused...

Faraday Close, Worthing, West Sussex, BN13 3PL United Kingdom Phone: + 44 (0)1903 268500 Contact your local sales representative Document Number HA029089 Issue 7 Watlow, Eurotherm, EurothermSuite, EFit, EPack, EPower, Eycon, Chessell, Mini8, nanodac, piccolo and versadac are trademarks and property of Watlow its subsidiaries and affiliated companies. All other trademarks are the property of their respective owners. V WATLOW. Powered by Possibility 11.300 Controls for Identification Codes / Passwords ©Watlow Electric Manufacturing Company. All rights reserved.