K-Patents PR-23 for K-Patents Appendix - Manual (Page 30)

Document/Revision No. IM-GB-PR23-VACCINES: Rev. 1.01 Effective: November 1, 2013
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Appendix to the Instructions Manual PR-23
5.4 Electronic Data Management and Data Storage
The Code of Federal Regulations (CFR) FDA 21, Part 11 requires that pharmaceutical
companies use electronic (i.e. software-maintained) data recording and storage, rather
than paperwork. In case of instrument measurements, the code requires that every reading
taken with the instrument must be logged and permanently stored electronically, and the
data is password-protected ensuring alteration accountability (i.e. which operator makes
an alteration) and tracking.
Part 11 describes four basic system elements that must be addressed. They are:
● Electronic signatures and tracking
● Data storage and logs
● Security
● System validation.
5.5 Electronic Signatures/Audit Trail
Data records must be linked to the relevant electronic signatures so that when accessed,
either electronically or through printout, the signatures will be openly displayed along with
the date and time of execution.
5.6 Record Keeping
Data records must be stored in a format that the FDA can reasonably expect to be able to
read. These records must be retained for the length of time required by the predicate rule.
5.7 Security
System access can be restricted to authorized individuals using the lock on the Indicating
transmitter door and password-protected access to the indicating transmitter and to the
computer. There are also four input switches behind the front panel of the indicating
transmitter. The input switch can be configured to seal the calibration and to prevent
access to the calibration and to configuration, see PROCESS REFRACTOMETER PR-23
INSTRUCTION MANUAL, Section 6.4.
The actions of these authorized individuals in relation to the data must be openly accounted
for throughout the audit trail.
5.8 System Validation
The system must be validated to prove that it complies with the technical requirements of
Part 11. The Installation Qualification, Operation Qualification, and Performance Qualification
(IQ/OQ/PQ) should also be performed.