Installation Qualification:
Installation Qualification (IQ) is documented verification for successful Installation of Software/ Equipment/ Instrument/ System.
In system life
cycle and during validation stage, the Installation qualification plays a
crucial role. As per Traditional qualification, the definition of IQ is “ The documented verification that a system is installed according
to written and approved procedure”. Similarly as per GAMP 5 the meaning of
Installation qualification is that “Installation qualification is checking,
testing, or other verification to demonstrate correct Installation of software,
hardware and the configuration of software & hardware also”.
If we ask what
is crucial role of Installation qualification during system life cycle and during
validation stage? So we can understand with below example:
Suppose based on
requirement specification, “X” make, model and version of software was finalized
which was able to fulfill the requirement of any firm. But by mistakenly during
Installation of software, “Y” version of software was installed and this “Y”
version of software is not able to fulfill the some specific requirements.
During Operational qualification and performance qualification, this mistake was
not identified and software was release for routine use. Then imagine what will
be impact on business? The answer is that respective system is not able to meet
the requirements and the whole activity of software procurement, qualification
is waste and useless.
The next question
is why this software becomes useless? Then answer is “during qualification, the
installation of correct version of software was not verified”.
No any
guidelines provide accurate content or steps to perform Installation
qualification but provides the base concept for IQ. As per GAMP-5 the purpose
of IQ is given as “To verify and document that system components are combined
and installed in accordance with specifications, supplier documentation, and
local and global requirements. Installation testing provides a verified
configuration baseline for subsequent verification and validation activities,
and verifies any installation methods, tools, or scripts used. This forms the
basis for configuration management of the installed system. This “static”
approach to installation verification is typically applied to process control
systems and automated equipment.”
A pre-approved IQ document should be prepared by
considering the critical thinking. A strategy should be defined in this IQ document
for performing the verification activity. Below are the some basic details for verification
during Installation qualification:
Physical
check (Pre-Installation):
a- Availability
of user manual, guides from supplier.
b-
Comparison
of order for supply of complete system components (without damage).
c-
Supply
of correct make/ model/ version of system.
d- Availability of certificate of system.
e-
Availability
of trained engineer who going to perform installation along with certificate on training of respective system.
f-
Suitability
of workplace and location place according to pre-check requirements.
Post-Installation verification:
g- Installation of correct make/ model/ version of system
(software/ Instrument/ Equipment/ Device etc.).
h- Correct configuration of software and hardware.
i-
Verification
of error and warning during Installation and acceptance level of identified
error and warning.
j-
Confirmation
from supplier/ Installation engineer for successful Installation of system.
Based on critical thinking w.r.t respective system,
the verification point may be extended to cover the criticality of system and
to give assurance for patient safety.
Pass/ Fail: During verification check, if all the point meets the
acceptance criteria, the Installation qualification can be considered as pass
and completed. If some of verification point required action, then based on
criticality of identified action decision can be taken for further movement of
qualification and same should be documented.
Sometime during Installation, latest version of
software available and vendor suggested to install the same. An evaluation
should be required to confirm that respective latest version of software meeting
the requirement specification or not. If found satisfactory then same can be
installed and documented.
Abhishek Singh is the author of Pharma technical support. He is pharmaceutical professionals, having experience of more than 12 years in Quality.