Appendix C. Statements of Compliance
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organization authority grants user access rights on an individual basis, we understand that the
instrument fits the description of a “closed system” found in this article.
Requirement: § 11.10 (a) Validation of systems to ensure accuracy, reliability, consistent intended
performance, and the ability to discern invalid or altered records.
Progeny 1064: This article addresses validation in a way that is not limited to the instrument. As a result,
the validation process for Progeny instruments includes factory calibration, routine calibration,
instrument self-test, and the provided documentation for implementing operating qualification of
instrument results.
Requirement: § 11.10 (b) The ability to generate accurate and complete copies of records in both human
readable and electronic form suitable for inspection, review, and copying by the agency. Persons should
contact the agency if there are any questions regarding the ability of the agency to perform such review
and copying of the electronic records.
Progeny 1064: The instrument produces electronic records that include all instrument and scan data
using security features necessary for compliance with this article. These records are available in a
number of human readable formats including PDF, JPEG, and SPC (open binary standard spectroscopy
format).
Requirement: § 11.10 (c) Protection of records to enable their accurate and ready retrieval throughout
the records retention period.
Progeny 1064: Instrument and scan records cannot be altered on the instrument. In addition, the
instrument cannot permanently store electronic records. Once scanning is complete, electronic records
must be delivered to a secure location that is provided and controlled by the primary system
administrator of the organization through a RAD proprietary secure TCP/IP data-synchronization
process.
Requirement: § 11.10 (d) Limiting system access to authorized individuals.
Progeny 1064: In contexts that require compliance with the 21 CFR Part 11, all users must first be
granted user accounts by the primary system administrator before they can use or configure the
instrument. When implemented, user access to all functions is restricted by user names and passwords
that reside on the instrument itself. In addition, administrative controls or institutional policies should
restrict physical access to the instrument when it is not in use.
Typically, users with the Operator permission level may perform instrument self-tests and basic sample-
scanning tasks. Users with the Developer permission level typically may perform both Operator tasks
and spectral-library management and application implementation tasks. Users with Administrator
permission level typically may perform Operator tasks, Developer tasks, and user management tasks
such as create and edit user accounts, reset passwords, and implement other access restriction tasks. By
default, the primary Administrator account has access to all instrument functionality.
Requirement: § 11.10 (e) Use of secure, computer-generated time-stamped audit trails to independently
record the date and time of operator entries and actions that create, modify, or delete electronic records.
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...
