Rigaku Progeny, Руководство пользователя

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Appendix C. Statements of Compliance 105
1006232_RevD
Appendix C. Statements of Compliance
“Statements of Compliance” contains all required certification and compliance statements and includes:

Statement of Compliance, 21 CFR Part 11

United States Pharmacopeia (USP) Chapter <1120> - Raman Spectroscopy Statement of
Compliance

European Pharmacopeia (Ph. Eur.) Chapter 2.2.48 - Raman Spectrometry Statement of
Compliance
Statement of Compliance, 21 CFR Part 11
Introduction
21 CFR Part 11 titled “Electronic Records and Electronic Signatures” came into effect August20, 1997
both to govern the use of state-of-the-art technology, and to prevent falsification, abuse, or inadvertent
corruption of electronic data and electronic signatures. The regulation sets forth the requirements that
computerized systems need to fulfill for electronic signatures and records to replace handwritten
signatures on paper records.
Procedures fully complying with these requirements include:

Administrative and procedural controls which ensure that persons who develop, maintain, or
use electronic records and signature systems have the education, training, and experience to
perform their assigned tasks

Technical and system controls that provide computer-generated, time-stamped audit trails for
system activities, electronic records, and electronic signatures

Computerized system validation for systems that include:

Hardware

Software

Users

System-controlled validation policies and procedures

Controlled access to the computerized system

Electronic signatures for authenticating electronic records

Storage of electronic records
The following sections provide excerpts of relevant 21 CFR Part 11 articles, and RAD’ corresponding
strategies for addressing the articles’ core requirements with the Progeny 1064. These excerpts are for
information purposes only, and do not provide comprehensive coverage of the 21 CFR Part 11
regulation. For more information, contact RAD.
Articles and Assessments
Definition: § 11.3 (4) Closed system means an environment in which system access is controlled by
persons who are responsible for the content of electronic records that are on the system.
Progeny 1064: In order to use the Progeny instrument in contexts that require compliance with the 21
CFR Part 11, all users must first be granted user accounts or given appropriate administrative access as
determined by an organization’s primary system administrator. In instances for which a single