Appendix C. Statements of Compliance
108
1006232_RevD
Requirement: § 11.10 (k) Use of appropriate controls over systems documentation including (1)
adequate controls over the distribution of, access to, and use of documentation for system operation and
maintenance (2) revision and change control procedures to maintain an audit trail that documents time-
sequenced development and modification of systems documentation.
Progeny 1064: While the instrument internally maintains an audit trail for any changes to system
configuration made by developers and administrators, it does not document policy and procedure
changes. Consequently, in contexts that require compliance with the 21 CFR Part 11, organizations must
implement policies and procedures for tracking and documenting any changes made to instrument
configuration and use.
Requirement: § 11.30 Controls for open systems.
Progeny 1064: In contexts that require compliance with the 21 CFR Part 11, the instrument is configured
as a closed system by default. As a result, organization policies and procedures for controls for open
systems are not relevant.
Requirement: § 11.50 (a) Signed electronic records shall contain information associated with the signing
that clearly indicates all of the following: 1) The printed name of the signer, 2) The date and time when
the signature was executed, and 3) the meaning (such as review, approval, responsibility or authorship)
associated with the signature.
Progeny 1064: When confirming records, the instrument creates an electronic record of each
confirmation that includes information about when the signature was applied to the record, which user
signed it, and a memo stating the reason it was signed.
Requirement: § 11.50 (b) The items identified in (§ 11.50 (a)) shall be subject to the same controls as for
electronic records and shall be included as part of any human readable form of the electronic record
(such as electronic display or printout).
Progeny 1064: The instrument creates records of confirmations described in § 11.50 (a) in the same way
as it creates other electronic records, and provides same record transfer and output features for records
of confirmations as it does for other electronic records.
Requirement: § 11.70 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.
Progeny 1064: Users electronic signatures are embedded in all electronic records and cannot be excised
or copied.
Requirement: § 11.100 (a) Each electronic signature shall be unique to one individual and shall not be
reused by, or reassigned to, anyone else.
Progeny 1064: Duplicate user names are not available on an instrument. In addition, while user names
can be edited, and user accounts can be disabled, user accounts cannot be deleted from an instrument.
As a result, each electronic signature will be traceable to a user account on a particular instrument.
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...
