Page 70 - LC-SFC_Pharma_Brochure

C191-E041

Technical Data Integrity Compliance Using
Report the LabSolutions Report Set

Mamoru Kikumoto 1

Abstract:

A recent topic related to analytical data is the lack of data integrity due to data modification and replacement. Whether caused
intentionally or accidentally, such problems are often the result of incorrect operating procedures. Accordingly, the question of how
to ensure data integrity has become a pressing issue for analysis laboratories.
In addition to the sophisticated security functions provided in the previous version, LabSolutions DB/CS version 6.50 includes a new
Report Set function that enables the visibility of software operations. Therefore, not only can it help ensure the reliability of the
analysis data required by analysis laboratories but, it can also cut decrease the amount of time needed to check analysis results to a
half of or a third of that previously required.

Keywords: data integrity, Report Set

1. Data Modification In that form, the following was included as "OBSERVATION 1."
1. Data Modification
OBSERVATION 1
A recent topic related to analytical data is the lack of data integrity
due to data modification and replacement. Whether caused inten- "... The Quality Unit failed to: review electronic data as part of batch re-
tionally or accidentally, such problems are often the result of in- lease, review computer audit trails in the Waters Empower Data Acqui-
correct operating procedures. Accordingly, the question of how to sition System and provide adequate training to analytical chemists. ..."
ensure data integrity has become a pressing issue for analysis lab- This indicates that the chromatography data system is being called into
oratories. question.

The form also included the following.
Actual Pharmaceutical Company
2. Actual Pharmaceutical Company • OOS results were substituted with passing results by Analysts and Su-
2.
Case pervisors.
Case
The FDA (the U.S. Food and Drug Administration) currently issues • Changed chromatogram headers by cutting and pasting, so during
a large number of warning letters and Form FDA 483s related to review all sample injections would appear to be in sequence. ..."
data integrity. These notifications have reportedly been triggered by This indicates that:
a case of fraud committed by a generic drug manufacturer based in • Non-conforming test results were replaced with passing results and
the state of New Jersey in the United States. An FDA audit of an
actual pharmaceutical company in 2005 revealed inconsistencies • Chromatogram headers were modified by cutting and pasting.
between paper-based and electronic data at the analysis laboratory
and revealed that non-conforming test results were never investi-
4. FDA Response
gated. Consequently, the company halted shipments, recalled all 4. FDA Response
products, and stopped manufacturing. Furthermore, they withdrew According to the GMP News report from the ECA , the FDA re-
4)
5)
seven generic drug applications. Then, after filing bankruptcy in Oc- sponded to the above case as follows.
tober 2005, they were purchased later that year by a different phar-
maceutical company. The chairman and CEO resigned and four re- Triggered by the cases of fraud at Able Laboratories in 2005, the re-
quirements for audits of data integrity during FDA Pre-Approval in-
sponsible persons were accused of criminal activity. 1), 2), 3)
spections have been set in the Compliance Programme Guide (CPG)
7346.832. Moreover, FDA's inspectors have been explicitly trained on
3.
3. Form FDA 483 computer systems and the data they contain.
Form FDA 483
The FDA issued Form FDA 483 to Able Laboratories and posted it on
the FDA website. 1)

1 Analytical & Measuring Instruments Division 1