Improving the Data Integrity of Spectrometers
Why is Data Integrity Important?
Data integrity refers to the completeness of data, with nothing missing or inconsistent. In other words, not only the data itself but also the metadata (the results of work that require human intervention such as specifying conditions and analyzing data) must be presented in a visible form and verified together.
Nowadays more and more data are recorded electronically with the aid of modern instruments and computers. It becomes imperative to set criteria and guidelines for keeping the integrity of electronic data. The United States Food and Drug Administration (FDA) issued regulations pursuantto Code of Federal Regulations Title 21, Part 11 (21 CFR Part 11) on August 20, 1997. These regulations define the criteria under which electronice records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records with handwritten signatures. They also provide guidelines for submission of electronic records to the FDA. Making the spectrometer operations 21 CFR Part 11 compliant is of key importance to maintain data integrity for many corporations today.
Firms are routinely audited to check for integrity of electronic data. The following actual warning letters have been issued by the FDA in the recent years, demanding swift response regarding analytical instruments that do not support data integrity:
The following warning letters have been issued by the FDA, demanding swift response regarding analytical instruments that do not support data integrity.
|Warning Letter: 320-18-55 Issue Date: May 23, 2018
You did not have procedures for reviewing audit trails or electronic data for the Fourier-transform infrared spectroscopy or ultraviolet systems.
|Warning Letter: 320-17-25 Issue Date: February 24, 2017
Our investigator observed that your laboratory systems lacked controls to prevent your staff from altering or deleting electronic data. Analysts manipulated and deleted audit trails. You lacked adequate controls for all HPLC, gas chromatography, and ultra-violet systems.
|Warning Letter: 320-17-01 lssue Date: October 13, 2016
In response, to this letter, provide details of your retrospective review of HPLC and other laboratory data, such as Fourier transform infrared spectroscopy, gas chromatography, UV spectrophotometry, and (b)(4) analyzer data.
|Warning Letter: 320-15-09 lssue Date: April 6, 2015
You lacked controls to prevent the unauthorized manipulation of your laboratory's electronic raw data. Specifically, your infrared (IR) spectrometer did not have access controls to prevent deletion or alteration of raw data.
How does Shimadzu Support Customers’ Compliance to 21 CFR Part 11?
To support customer compliance with FDA regulations, Shimadzu compiles the latest information on FDA regulations, develops products based on this information, promotes customer education on compliance issues via seminars and other means, provides customer assistance and offers support for FDA inspections. It can be seen from the following diagram that proper support for FDA comprises various aspects. Perhaps what contributes most is the software that controls the spectrometer operation. The LabSolutions database software is required for spectrometers that need to be FDA compliant.
How does LabSolutions database keep data integrity?
Shimadzu achieve FDA 21 CFR Part 11 compliance through integrated control of data for Shimadzu molecular spectrometers based on the LabSolutions database. Introduction of the LabSolutions database creates a close system as defined in 21 CFR Part 11.
LabSolutions database must be installed on a NTSF configured hard drive and runs on a Windows 32 bit or 64 bit computer. Access to the system requires input of a user ID and a password. The system administrator has the rights to set security policies, create or invalidate a user account, decide functions that are accessible for each user, lock/unlock certain users, etc.
LabSolutions maintains three different logs: the data log that records operations conducted on the analytical data; the system log that records system logins, logouts and changes to the environment settings; and the user authentication log that records changes to user registration details. These logs are generated automatically by the computer and kept in database formats. These logs are mutually independent as the method of control is different for each one: the data log is controlled along with the data it relates to and the system log is saved separately from specific data. Each time a new analysis or data reprocessing is performed, calculated results, raw, method and schedule data is automatically saved in a database along with the audit trail. This data is protected from being overwritten or deleted, thereby ensuring an adequate audit trail capability.
LabSolutions database offers schedule and method (including time programs) functions that permit customer to preset sequences. The schedules and methods are stored in the database with analysis results when an analysis is run, allowing confirmation that the analysis has been run according to the sequence.
The electronic signatures function incorporates the printed name of the signer, date and time when the signature was executed, and the meaning associated with the signature (such as approval). The signatures are displayed with these elements in the electronic records list. The signature information is simultaneously retained in the operation log. The contents of the operation log cannot be copied or moved, and the operation log can be deleted only after it is archived.
Data generated by this system contains all the required information provided in the table below. This information is stored in a single file and cannot be separated, allowing for a complete record to be retained in a machine-readable format. An accurate report can also be produced in a human-readable form.
The LabSolutions database has the following features regarding to the saved data records:
- Protection of records
Data files are stored together with meta data (methods, schedules, etc.) in a safe, access-controlled SQL Server database.
- Rapid searching
LabSolutions search function allows for a ready record retrieval as data files are stored in a database.
- Recovering records
Data can be archived to removable media, such as CD-R for long-term storage. This data can be referenced directly from the CD, without copying it back to the hard disk, and can be fully recovered to its original state from the database, when required.
How is LabSolutions database validated?
Validation of the software is necessary to ensure that no alteration of the installed software has occurred. Shimadzu supports validation operations by issuing an IQ (Installation Qualification) Protocol to confirm that installation was conducted correctly and OQ (Operational Qualification) Protocol that defines periodic system checks.