Data Integrity Test
ALCOA+
ALCOA+
A
Attributable
Authentication, Unique ID, Access permission
Legible
Human readable, Usable format
Contempora
neous
Recorded at the time of the event, audit trail
Original
Audit trail, record linking
Accurate
Reliable, calibrated
7th Most Common Citation
Your firm failed to document production and
process control functions at the time of
performance
Operator recorded the amount of material
dispensed before it was dispensed
Employees admitted they do not record
activities at the time of performance
QA employee signed as reviewing and
releasing a batch when he did neither
6th Most Common Citation
Your firm blended out-of-specification API
batches with passing batches to meet
specification.
Failing results were often kept in
separate folders and the failing data
was not considered when making
release decisions
5th Most Common Citation
Your firm did not document laboratory
activities at the time of performance.
Pre-dating or backdating laboratory
records
Occurred for assay, loss on drying,
sample weighing, and stability testing
4th Most Common Citation
Your firm failed to maintain complete
information relating to the production and control
of each batch
Records for 23 batches did not contain batch
numbers, manufacturing dates, expiration or
retest dates
Approximately 75 ripped batch production
records (BPRs) were found in the garbage
(some with failing results)
4th Most Common Citation
Ten bags of torn or partially destroyed
original records including CAPAs,
preventative maintenance forms, and
calibration records were found
Raw data was written on scratch paper and
sometimes differed from the data in the BPR
Correction fluid was used on production
records
3rd Most Common Citation
Your firm failed to thoroughly investigate any
unexplained discrepancy or failure of a batch or any of
its components to meet any of it specifications, whether
or not the batch has already been distributed
4 batches of failing API were used in fifteen finished
dosage batches
Failing assays were repeated until passing results
were obtained (occurred at numerous firms)
Environmental monitoring results were recorded as
zero but actually had growth
3rd Most Common Citation
Unofficial visual exam conducted for
sterile injectables to remove vials with
visible contamination so that the batch
would pass the official visual exam
(occurred at 2 firms)
Used three different analytical methods
until obtaining passing results
2nd Most Common Citation
Your firm failed to exercise appropriate controls over computer
or related systems to assure that only authorized personnel
institute changes in the master production and control records,
or other records
Audit trails were disabled
A shared username and password was used by many
analysts
Users were able to manipulate, delete, or overwrite
electronic raw data
Firms laboratory practice is to print chromatograms and
delete electronic raw data files
Most Common Citation
Your firm failed to ensure that laboratory records included
complete data derived from all tests necessary to assure
compliance with established specifications and standards
trial sample injection data was not kept as part of the
data for a batch
Sample weights, sample preparation and sample
dilutions were not retained
Deleted data detected in audit trails
Overwriting data
Ripped up data found in the garbage
Most Common Citation
Microbiological data missing
Not reporting microbiological counts
Hundreds of environmental monitoring samples
were not collected
Some microbiological sample plates/tubes were
missing from the incubator
No microbiological testing was conducted;
however, microbiological test results were
reported on the certificate of analysis (COA)
Most Common Citation
Certificates of analysis missing data:
Data on the COA sent with the batches was different
than the COA the firm retained on file
COA retest date was changed to an expiration date
and listed as eleven months later
No raw data in support of results reported on COA
Samples with no identification were discarded
during the inspection
Most Common Citation
Firm deleted all electronic raw data supporting
HPLC release testing
Standards were injected and used as sample
results
Duplicate logbooks were kept
Complete raw data to support test method
validation was not retained
Integration parameters for HPLC analysis were not
retained
ALCOA
ALCOA
ALCOA
ALCOA
ALCOA
ALCOA
ALCOA
ALCOA
ALCOA
ALCOA
Data Review
Data Review
Data Review
Data Review
Data Review
Data Review
Data Review
How Can You Be Part of the Solution
Look for gaps in how you control your
records
Ensure employees have appropriate user
privileges
Audit your data in a risk-based manner
Verify the authenticity of your
contractors data
Data Integrity in QC
Trial
Injections
Reprocessi
ng
DATA
INTEGRI
TY
Orphan
Data
PaperBased
Review
