Data integrity in the analytical laboratories is an area of increasing focus for regulatory authorities such as FDA, EU, TGA etc.
Data Integrity
The data which is attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).
During regulatory inspection/audit analytical laboratories have to provide information about the validation of their methods and procedures, the qualification and suitability of their analytical equipment, and information about training of their laboratory staff as justification for the validity of the analytical results.
But in a data integrity-focussed audit, the emphasis has moved away from providing information based on technical justification and scientific rationale towards providing evidence that the analytical results are not fraudulent. This is almost a “guilty until proven innocent” approach and can be very different to historical audits.
For any laboratories that are not prepared for this change, the audit will at best be “uncomfortable” and at worst may present a potential high risk to the organization.
Analytical Data under Data Integrity Audit
The most important types of data are collectedare from analytical laboratories are listed below:
- data from the tested batch and data on personnel who carry out and control the testing processsampling and sample storage data, records and observations
- weighing and sample preparation, standards and reagents used
- qualification and calibration data for the pipettes and balances used
- qualification data for all of the devices used
- instrument control data (detector wavelength range, flow, temperature, etc.)
- sequence data in full
- data to be recorded (e. g. data rate, integration parameters, etc.)
- chromatography testing data (initial electronic data, peak areas)
- processed data from chromatography testing (processed electronic data)
- measuring process and device-specific calibrations
- device-specific calculations
- peak areas after integration
- HPLC calibration data
- calculation data (software-based or completed manually)
- trend analyses
- all system suitability test results
- reports generated from electronic data (sample-list printouts, chromatograms, etc.)
- audit trail data and all deviations and changes
- documented observations
- if applicable, calculations carried out using external software (LIMS, Excel) = derived data, results (reportable result), evaluation (with OOS, OOE, OOT)
All of this data should comply with the ALCOA principles and, in an ideal situation, the ALCOA plus principles.
Read also: Frequently Asked Questions on Data Integrity
Common Data Integrity Issues of Laboratory Data
Common data integrity issues encountered during review of electronic laboratory data (HPLC/GC/UV/FT-IR/Karl Fischer/Particle Counts)
- Trial Sample Analysis
- Deletion/Overwrite of Data
- Testing Into Compliance
- Back-door Manipulation
- Administrator Foul Play
- Physical manipulation
- Extraneous peaks not processed
- Manual reintegration
Trial Sample Analysis
Prior to testing the ‘official’ samples, trial samples are pre-tested to determine if they will meet specifications.
Deletion of Data
Source data is deletable from the hard drive of the associated computer.
Testing into Compliance
When undesirable results are encountered, samples are retested until acceptable results are achieved.
Back-door Manipulation
- Changing the sample weight.
- Increasing or decreasing peak cut-off points to achieve passing results.
Administrator Foul Play
Using Administrator privileges to turn off/on audit trails – hide trial analyses or data manipulation.
Physical Manipulation
Forcing the equipment to fail to provide a reason for invalidation of already generated data.
Others
- Sharing user names and passwords
- Backdating of analyses, such as stability tests, in order to meet the required commitments
- Reuse of old data, passing it as new data, to avoid performing supplementary analyses
- Failure to record activities at the time they are performed
- Creation of false records during an inspection
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