Data Integrity Issues


In a recently posted FDA warning letter USV Limited, Mumbi India, was cited for two instances of data integrity issues.  Specific citations identified in the warning letter include:

Citation 1- backdating, using backdated printouts, and submitting them as raw data.

  • Our investigators found that laboratory analysts did not document the balance weights at the time of sample weighing. Specifically, sample weights used in calculations were created after the chromatographic runs.  The analyst admitted that the sample weights that were represented as raw data from the analysis actually were backdated balance weight printouts produced after the analysis and generated for the notebooks.  These sample weights were used to calculate related compounds and impurities used in support of method validations submitted in FDA drug applications.

Citation 2- Lack of control of computer systems, disabled audit trail function, use of shared log in and passwords,

  • Your firm failed to have adequate procedures for the use of computerized systems in the quality control (QC) laboratory.  Our inspection team found that current computer users in the laboratory were able to delete data from analyses. Notably, we also found that the audit trail function for the gas chromatograph (GC) and the X-Ray Diffraction (XRD) systems was disabled at the time of the inspection.  Therefore, your firm lacks records for the acquisition, or modification, of laboratory data.
  •  Moreover, greater than [redacted] QC laboratory personnel shared [redacted] login IDs for [redacted] high performance liquid chromatographs (HPLC) units. In addition, your laboratory staff shared one login ID for the XRD unit.  Analysts also shared the username and password for the Windows operating system for the [redacted] GC workstations and no computer lock mechanism had been configured to prevent unauthorized access to the operating systems. Additionally, there was no procedure for the backup and protection of data on the GC standalone workstations.

In 2009 USV Limited, identified that all analytical method validation studies submitted to the agency since 2006 had been audited.  However, internal audits of laboratory practices failed to identify these issues.  In response to this warning letter, USV Limited is committed to hiring a third party auditor experienced in detecting data integrity issues to investigate these issues.

Do your internal audits challenge the system that they are intended to review, or are they performed as a formality?  Would your audits and auditors have identified these issues?