bioline
bioline
The PQ consists of inspections of
the correct operation of the cabinet
under predefined conditions and
procedures. Prerequisites for the
PQ are IQ (Installation Qualification)
and OQ (Operation Qualification),
these must be concluded success-
fully prior to the initiation of the PQ.
This PQ is intended for the following
product series:
BioCompact, BioCompact II,
BioPlus, BioMidi
Revision 10/10/2017_001
Customer: Location of installation:
Person responsible for the cabinet:
Person responsible for test:
Person responsible for verification of test:
Test duration:
Model:
Item number:
(manual)
SN:
Name:
Date:
Signature:
Name:
Date:
Company:
Signature:
Name:
Date:
Company:
Signature:
Initation (date/time):
Conlusion (date/time):
PQ
Performance Qualification - Page 1/13
Model:
SN:
bioline
The following IQ / OQ is
intended to be a guideline,
local IQ / OQ procedures can
vary depending on application
and items stored in the Gram
BioLine cabinet.
Deviations from the
specifications dictated in the
PQ are to be reported in the
deviation report.
The IQ / OQ is concluded if
all criteria of acceptance are
approved and the possible
deviations are rectified or
accepted.
This IQ / OQ is intended for
the following product series:
BioCompact / BioCompact II
Revision: 10/10/2017_001
Customer:
Location of installation:
Model:
Serial number:
Item number - manual:
Status of operation:
Active
Inactive
Name of distributor:
Warranty:
Start:
End:
IQ & OQ
Gram BioLine - Page 1/8
Model:
SN:
49
b i o l ine
GMP Documentation
IQ, OQ & PQ
IQ, OQ and PQ documentation is readily available for
all BioCompact ll cabinets.
For Installation, Operation and Performance
Qualication documentation please go to our website:
www.gram-bioline.com