GxP Assessment Pre-Approval Checklist

This checklist is used to assess whether a computerized system is GxP-relevant and

determine the applicable compliance requirements based on the type of GxP.

# GxP Assessment Yes No Remarks

Category Question
1 GMP Does the
system
manage data
related to
manufacturi
ng,
packaging,
or quality
control of
pharmaceuti
cal
products?
2 GMP Is the
system used
for
production
planning,
batch
records, or
inventory
management
?
3 GMP Does the
system
handle
controlled or
regulated
environment
data (e.g.,
temperature
, humidity
for storage)?
4 GMP Does the
system
provide
traceability
of raw
materials,
intermediate
products, or
finished
 goods?
5 GMP Does the
system
support the
creation or
modification
of master
batch
records or
product
specification
s?
6 GCP Does the
system
manage
clinical trial
data (e.g.,
subject data,
trial
protocols,
results)?
7 GCP Is the
system used
to record
informed
consent or
clinical
outcomes
for human
trials?
8 GCP Does the
system store
or manage
data that
will be
submitted to
regulatory
agencies
(e.g., FDA,
EMA)?
9 GCP Is the
system
involved in
the
monitoring
and
reporting of
adverse
events or
 clinical data
discrepancie
s?
10 GLP Is the
system used
in non-
clinical
safety
testing (e.g.,
animal
studies,
chemical
testing)?
11 GLP Does the
system store
experimenta
l data,
protocols, or
analysis
results
related to
non-clinical
research?
12 GLP Is the
system used
for tracking
or auditing
laboratory
instruments
or test
conditions?
13 GLP Does the
system
manage
quality
assurance
(QA) of
laboratory
operations?
14 GMP, GCP, Does the
GLP system
handle
electronic
records that
need to
comply with
21 CFR Part
11 / EU
Annex 11 for
 data
integrity?
15 GxP General Does the
system
generate or
manage
audit trails
for data
modification
s and user
actions?
16 GxP General Is the
system
validated to
ensure it
meets
performance
and
regulatory
requirement
s for GxP
activities?
17 GxP General Is the
system
subject to
change
control
procedures
to ensure
ongoing
compliance?
18 GxP General Does the
system have
role-based
access
control to
restrict data
access based
on user
roles?
19 GxP General Is the
system
capable of
backup and
recovery to
prevent loss
of critical
data?
20 GxP General Does the
 system
maintain
proper
documentati
on (e.g.,
SOPs, user
manuals,
validation
protocols)
for its
operation
and
maintenance
?
21 GxP General Does the
system
provide
periodic
reviews and
ongoing
monitoring
to ensure
continued
GxP
compliance?
22 GxP General Is the
system used
to track data
that could
have an
impact on
product
quality or
patient
safety?
23 GDP Does the
system
manage
distribution
and shipping
data for
pharmaceuti
cals or
medical
products?
24 GDP Is the
system
involved in
tracking
inventory
 and
movement
of products
from
manufacture
r to
wholesaler
or retailer?
25 GVP Does the
system track
or manage
adverse
drug
reactions or
pharmacovi
gilance data?
26 GVP Is the
system used
for reporting
safety
concerns or
regulatory
compliance
to
authorities
(e.g., FDA’s
MedWatch)?
27 GPP Does the
system
handle data
relevant to
dispensing
medications,
patient
records, or
inventory
management
in a
pharmacy?
28 GPP Does the
system track
medication
errors,
patient
safety
incidents, or
drug
interactions?