Biologics Bioanalalysis Compendium

For Research Use Only. Not for use in diagnostic procedures.
Figure 6: Grouped audit events. The system logs multiple change to integration methods in the audit trail and prompts for electronic signature once.
Figure 7: Powerful audit trail viewer. The viewer displays events and the associated data with hyper-linking. The data is shown before and after each audited event. The reviewer can quickly spot the impact of a change. Results tables and peak review are automatically linked to the audit trail.
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Powerful review functionality – All versions of a data set, before and after manipulations and calculations, must be collected and saved for the audit trail. MultiQuantM Software 3.0 introduces a dedicated data review function that links all versions of the data to the audit trail. Now reviewers can view data before and after an auditable change (Figure 7). Data review and audit trail view panes are linked for easy and ef cient data review. The software also prevents accidental changes in the data by warning if the data has been changed during review. This warning feature can be activated by the administrator.
Quality assurance review features – Audit trails need to be searchable, so that reviewers can locate speci c events rapidly and effectively during the quality assurance process, capturing and
linking related events to the audit trail. MultiQuant Software 3.0 design facilitates ef cient quality assurance practices, allowing supervisors to concurrently review multiple batches within a project – providing essential time-savings – as well as search
all project tables to nd a speci c event or action captured in the audit trail (Figure 8). In addition, the reviewer can track a single sample across multiple batches, easily locating the original injection and re-injections in different results tables. The raw data for each injection and the resulting peak area integration are linked to each other and can be easily checked and tracked concurrently, aiding the validation of experimental data and ensuring that bioanalytical data standards are ful lled.
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Figure 8: Audit trail search capability. All manual integrations within a project can be quickly located and relevant versions of the data automatically displayed and linked to the audit trail. MultiQuant 3.0 software showing secure data transfer and audit trail log before exporting to Watson LIMSTM.
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Figure 9: Robust Watson Digital Link – Secure Data Transfer with Audit Trail Log. MultiQuantM 3.0 software showing results transfer to Watson LIMS in le menu options.
Validation of data integrity and security
Results table locking for improved data integrity – Untracked and unwanted alterations to experimental data puts a laboratory’s reputation at risk. To sustain outstanding data integrity throughout the results table generation process, administrators of MultiQuant Software can secure the data through a data locking feature to prevent further changes. The locking/unlocking authority de ned by the administrator can also be applied to data prior to export to laboratory information management software (LIMS) or prior to printing a report. The software also requires
the operator to save the results prior to printing or exporting.
A dedicated data review function has been added so that supervisors can review the data without accidentally changing the data in the process.
Watson digital link – secure data transfer with audit trail log – Data export to LIMS has traditionally been identi ed as a weak link in ensuring data integrity since text les have the potential to be tampered with after export and prior to LIMS import. To address this issue, MultiQuantM 3.0 Software now has a robust link with Watson LIMSd that allows for results transfer in a secure and compliant environment by encrypting the data prior to export. After receipt of the data in the LIMS system, the LIMS software can decrypt the data, all-the-while maintaining the data in a secured environment. This system of data transfer achieves higher productivity in the
GLP laboratory – eliminating multiple data management tasks and
liberating researchers from concerns about data hacking. Key steps for secure data transfer between MultiQuant 3.0 Software and Watson LIMS are displayed in Figure 9.
Enhanced compliance through checksum validation and secure reporting – Once a data le has been transferred, the data integrity must be re-veri ed and a tamper-resistant transfer process must be demonstrated. MultiQuant 3.0 Software provides a Data File Checksum feature, which will reject data with an invalid checksum whenever a wiff le (data le) is created. Analyst Software generates a checksum value using an algorithm based on the MD5 public encryption algorithm and saves the value into the le. When the checksum is veri ed, the software calculates the checksum, comparing it to the checksum stored in the le. This powerful validation process ensures data safety, and boosts regulatory con dence in the analytical output.
Even with these tamper resistant features, the generation of nal reports is also prone to errors, and the graphic display of data could be manipulated or corrupted during the data evaluation process. To maintain the highest level of data integrity, MultiQuant 3.0 Software also includes a powerful secure reporting functionality, ensuring that the GLP license holder is the only user who can edit the software’s encrypted report templates, limiting access to data output and preventing unwanted tampering.
For Research Use Only. Not for use in diagnostic procedures.
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Conclusions
MultiQuant Software 3.0 signi cantly reduces the amount of time required for data processing and review by automating and consolidating repetitive data processing tasks.
Increased ef ciency – MultiQuant Software can handle large data sets with thousands of MRM transitions using intuitive user interface for fast data processing and data review
Fast and easy software training – Easy-to-use user interface reduces the amount of time required to train new operators, and improve consistency
Single software solution to process both small molecule drugs and biotherapeutics such as proteins and peptides. Process multiple data types such as MRM, MRM3, TOF MS, SWATHTM acquisition and MRMHR on multiple instrument’s such as AB SCIEX Triple QuadTM System, QTRAP® LC/MS/MS System and TripleTOF® System
Save time by reducing tedious manual integration
Powerful and robust integration algorithms such as MQ4 will increase performance by automating peak integration with minimal manual intervention
Advanced query functionality will quickly identify samples that deviate from bioanalytical regulations
Data integrity and security
Ensures data integrity throughout with 21 CFR compliant features such as locking of results, secure reporting, robust Watson digital link, audit trail log and e-signatures
New and innovative audit trail functionality will allow easy search and present QA reviewers with track changes
References
1 MRM3 Quantitation for Highest Selectivity in Complex Matrices. AB SCIEX Technical Note, Publication 0920210-01
2 To download a trial version of MultiQuant Software, please visit: https://licensing.absciex.com/ download/index
3 MultiQuantTM Software 2.0 with the Signal FinderTM Algorithm: The Next Generation in Quantitative Data Processing.” AB SCIEX Technical Note, 2010.
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