Improving the Data Integrity of FT-IR Spectrometers – 3 important considerations for Regulatory Audit perspective.
In this post, we present an analysis of Form 483 observations and warning letters issued by USFDA; the classification includes:
- Lack of Data Integrity Controls and Audit Trials
- Failure to protect the Records
- Lack of Qualification, Procedures and documentation.
Lack of Data Integrity Controls and Audit Trials: major observation includes
- “Laboratory personnel can change and save changes to the date and time setting in the Windows operating system”.
- “With the FT-IR instrument, it was noted that the redacted software had an option to enable or disable automatic saving of measurement available to the chemist”.
- “The lack of an audit trail and No Audit Trail Review: Even when you have an audit trail in the application, it is either turned off or if it is turned on the entries are not reviewed”.
- “Analyst/QC operators have the option of not saving the IR spectra”.
- “Poor Security and Access Control: This is the biggest problem with issues identified such as no security, all users have the same identity, and password thus making attribution of action impossible and conflicts of interest where all laboratory users have administrator rights”
- “Data Falsification/Testing into Compliance found with the IR systems citations here include data deletion, and retesting until a passing result is obtained”.
- The major area for noncompliance before operational use of the instrument is due to failure to qualify or calibrate the instrument or validate the software.
Failure to protect the Records: major observation includes
- “The FT-IR analytical instruments are both equipped with commercial software that does not prevent accidental or intentional deletion of files containing data. The use of directories in the operating system for data storage where a user can delete spectral files without any record in the application software”.
- “There were no controls to prevent deletion of data and deleted FT-IR data was observed in the computer recycle bin”.
- Failure to Backup Data: This is a major problem when a laboratory is left to backup its own GMP records, and fails to do so. Almost all IR software is designed for standalone operation, or can be implemented as a standalone system.
Many standalone systems involve files storage in directories in an operating system, and not a database. If the software is designed to support networked implementation, using database storage on a secure network server, this should be implemented. This would remove many of the limitations of standalone systems, such as backup, as this would be performed by the IT department.
Lack of Qualification, Procedures and documentation-major observations includes
“Lack of Procedures: No procedure or work instruction available, and no training records for analysts Procedures for FTIR analysis not written and do not document current working procedures”.
“Inadequate Instrument Log Book Entries: Instrument log book entries missing and log book entries review missing and the failure of a second person to review them”.
When using infrared (IR) instruments in a regulated laboratory, it is essential to conduct meaningful performance qualification (PQ) tests to maintain compliance.
Verification of the instrument performance is essentially in the form of monthly checks confirming that the instrument is fit for use, and typical parameters that may be required for FT-IR performance measurement are:
- wavenumber accuracy
- resolution
- signal-to-noise ratio (S/N).