Professional Documents
Culture Documents
Data Integrity and Audits
Data Integrity and Audits
Data Integrity and Audits
Integrity Audits
Data is Recorded…
Electronic
Paper
Systems
October 12 - 13, 2017
General
GeneralData
DataIntegrity
IntegrityConcepts
Concepts
ORIGINAL RECORD
Data as the file or format in which it was originally
generated, preserving the integrity (accuracy,
completeness, content and meaning) of the record
Data Integrity:
The extent to which all data
are complete, consistent
and accurate throughout
the data lifecycle
Bad Practice
Intention
Procedures Or Fraud
and/or
cGMPs are
bypassed
knowingly
Data Integrity
October 12 - 13, 2017
Issue
General Data Integrity Concepts
Prevent Detect
Products
Regulatory
Agency, United
Kingdom)
Draft GxP Data Integrity MHRA https://www.gov.uk/government/uploa July,
ds/system/uploads/attachment_data/fil
Definitions and Guidance for e/538871/MHRA_GxP_data_integrity_c 2016
Industry onsultation.pdf
cGMP record not complete All electronic data generated to satisfy a CGMP
requirement is not included
History of finished
product test results
Critical process
parameters
- MHRA GMP Data Integrity Definitions and Guidance for Industry, March, 2015
October 12 - 13, 2017
DI Focus of Regulatory Inspections
- MHRA GMP Data Integrity Definitions and Guidance for Industry, March, 2015
October 12 - 13, 2017
DI Focus of Regulatory Inspections
Mgmt
Mfg Lab
October 12 - 13, 2017 - Takahashi: Look Out for These Data Integrity Issues
DI Focus ofFocus
Regulatory Regulatory Inspections
for Inspections
October 12 - 13, 2017 - Takahashi: Look Out for These Data Integrity Issues
DI Focus ofFocus
Regulatory Regulatory Inspections
for Inspections
October 12 - 13, 2017 - Bowman Cox, FDA GMP Warning Letters Review
Regulatory
DI Focus ofFocus for Inspections
Regulatory Inspections
October 12 - 13, 2017 - Bowman Cox, FDA GMP Warning Letters Review
Regulatory
DI Focus ofFocus
Regulatory
for Inspections
Inspections
API FDA warning letters
• Laboratory records and computerized systems
– Microbiologist did not record test results
contemporaneously
– QC worksheet completed after FDA investigators asked
for it
– Gas chromatograph clock set back to make it appear
stability test was done months earlier; failing tests deleted
– HPLC system configured to automatically delete aborted
tests, and turn back clock for passing results
October 12 - 13, 2017 - Bowman Cox, FDA GMP Warning Letters Review
DI Focus ofFocus
Regulatory Regulatory Inspections
for Inspections
October 12 - 13, 2017 - Bowman Cox, FDA GMP Warning Letters Review
DI Focus of Regulatory Inspections
• The backup CD/DVD for the autoclave control system was not
stored within a controlled environment to assure its integrity.
• Data from the integrity test was not backed up. The system was
observed to overwrite previous data.
• Access to files and the system clock on the hard drive was
available to all users
Questions?
Questions?