Appendix C. Statements of Compliance
107
1006232_RevD
Record changes shall not obscure previously recorded information. Such audit trail documentation shall
be retained for a period at least as long as that required for the subject electronic records and shall be
available for agency review and copying.
Progeny 1064: The instrument automatically creates electronic records containing all specified
information with valid audit trails. Once created, any changes invalidate the included audit trails.
Records with valid audit trails can be transferred by the data-synchronization process to a secure
location provided and controlled by the primary system administrator for permanent storage.
Requirement: § 11.10 (f) Use of operational system checks to enforce permitted sequencing of steps and
events, as appropriate.
Progeny 1064: In contexts that require compliance with the 21 CFR Part 11, the instrument can be
configured to have a strictly enforced workflow that will not allow operation outside of the permitted
sequencing of steps. For information about setting up restricted workflow sequencing, please contact
RAD.
Requirement: § 11.10 (g) Use of authority checks to ensure that only authorized individuals can use the
system, electronically sign a record, access the operation or computer system input or output device,
alter a record, or perform the operation at hand.
Progeny 1064: By default, the instrument has three levels of user permissions: Administrator,
Developer, and Operator. System administrators must specify one of these user permission levels when
creating or editing each user account.
Requirement: § 11.10 (h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity
of the source of data input or operational instruction.
Progeny 1064: The instrument records all data input in electronic records. In contexts that require
compliance with the 21 CFR Part 11, organization must put policies and procedures in place to preserve
the validity of this input.
Requirement: § 11.10 (i) Determination that persons who develop, maintain or use electronic
record/electronic signature systems have the education, training and experience to perform their
assigned tasks.
Progeny 1064: In contexts that require compliance with the 21 CFR Part 11, organizations must
implement policies and procedures both to appropriately control user access and to provide adequate
user training. For more information about user access controls and user training, contact RAD or your
local Rigaku representative.
Requirement: § 11.10 (j) The establishment of, and adherence to, written policies that hold individuals
accountable and responsible for actions initiated under their electronic signatures, in order to deter
record and signature falsification.
Progeny 1064: The implementation and adherence to such policies and procedures must be monitored
by organizations administrative procedures.
Содержание Progeny
Страница 1: ...1006232_RevD 3 Progeny and Progeny LT Analyzer User Manual Rev D...
Страница 74: ...Advanced Options 67 1006232_RevD Figure 40 Sample Application...
Страница 106: ...Export and Import Settings 99 1006232_RevD Figure 70 Progeny Settings Screen...
Страница 111: ...Appendix B Nose Cone Positions 104 1006232_RevD Appendix B Nose Cone Positions...
