K-Patents PR-23 for K-Patents - Manual (Page 32)

Document/Revision No. IM-GB-PR23-ACP: Rev. 1.0 Effective: December 15, 2011
32
Appendix to the Instructions Manual PR-23
6.3 Protocol Acceptance by Customer and List of
Tests Performed
A qualification protocol which provides details about the system, the scope and constraints
of the qualification, the qualification tests, test procedures and acceptance criteria should be
available for review and approval before the qualification begins. The protocol should also
contain an exception log to record any out of specification results, investigation and problem
resolution. After the qualification, the test results must be reviewed and approved before the
instrument can be put to routine use.
6.4 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 the 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.
6.5 Electronic Signatures/Audit Trail
Data records must be linked to the relevant electronic signatures so when accessed, either
electronically or through printout, the signatures will be openly displayed along with the date
and time of execution.
6.6 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 predicate rule.
6.7 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. The actions of these authorized individuals in relation to the data must be openly
accounted for throughout the audit trail.