Gubbs Inc.Creator of software tools that provide data

processing and reporting solutionswww.gubbsinc.com

GuWu® – PK/PD Study Design and Reporting Solution

Thermo Watson™ is an industry standard LIMS system used by laboratories that conduct protocol-driven bioanalytical studies.

Until recently, Watson has had limited tools for generating final reports, especially reports (Method Validation, Sample Analysis) generated in support of GLP studies.

Most users resort to exporting Watson tables to Microsoft® Excel or Word for further statistical processing and/or Word formatting.

The task of generating a complete report containing sufficient information requires more information and functionality than is currently available in Watson tools.

Final Reports (especially Method Validation) can typically take days to weeks to prepare and require a high level of QC and QA events to ensure all data is correct and accurate.

GuWu allows users to manage the report writing process and generate completely formatted Watson data-derived GLP study reports with the click of a button.

Entering table information into a GLP study report is not the most time-intensive step

The following steps are the most time-intensive and error prone steps: Formatting

Entering page content specific table legends Entering table titles Configuring non-breaking spaces and non-breaking

hyphens Entering compound specific data in report body section

Analytical Reference Standard information Summary Precision and Accuracy statements/tables Method Validation Summary information Sample receipt information

Hyperlinking References to tables, appendices and figures to must be

hyperlinked to actual table, appendix and figure. Method Validation Summary Table

Sample Analysis reports are expected to contain a table summarizing information determined in the Method Validation study/report.

Formatting Features Hyperlinking GuWu automatically configures Table, Appendix, and Figure hyperlinks when

referenced in the Body Text.

Non-breaking spaces (NBSP) and Non-breaking hyphens (NBH)

GuWu automatically configures NBSPs and NBHs in compound names and table/appendix/figure reference hyperlinks in order to prevent unwanted word-wrap occurances.

Extensive field code options

GuWu allows users to place several pieces of information in the report based on field codes configured by the user.

Signature Blocks Automatically generates several types of signature blocks based on Contributing Personnel information and Role assignments.

Table title generation Automatically generates user defined table names complete with analyte and time/temperature variables.

Automatic generation of multi-analyte reports

GuWu automatically generates sentences and tables for multi-analyte studies. There is no need to maintain separate templates for two-, three-, etc. analyte studies.

Automatic generation of legends

Automatically generates page content-specific legends for multi-page tables

Functionality FeaturesMulti-analyte reports Only one report template is needed for single or multi-analyte reports. GuWu

automatically modifies body text content and generated tables for all analytes.

Complete Inventory of Method Validation Reports

GuWu contains a complete inventory of tables expected of a GLP Method Validation Report, including Recovery Tables

Storing non-Watson information

GuWu has it’s own database to store information needed to generate a report, but which is not present in the Watson database. Most of this information is restricted to dropdown box choices (rather than free-form text as in Watson) – which allows administrators to enforce consistency when reporting some information (e.g. High Performance Liquid Chromatography – Mass Spectrometry).

Expanded table statistics functions

Allows users to configure an expanded statistics sections to include or not include outlier or rejected data points.

Outlier determination tool (Eval Outlier)

Eval Outlier automatically inspect Method Development QC tables for outliers and displays or prints outlier information. Using this information, users may determine whether or not to exclude data within Watson.

Incurred sample feature (TBR)

New recommendations by the FDA will require that Incurred Sample repeats be performed. GuWu will contain an intuitive simple Incurred Sample Assignment feature.

Automatic Method Validation information retrieval

In a Sample Analysis study report, GuWu will automatically retrieve and report either Watson or GuWu information from the Method Validation study associated with the Sample Analysis study. This eliminates the need for users to have to manually retrieve information located in electronic or hardcopy Method Validation reports or documents.

Generate Report Sections GuWu allows users to generate portions of the report (i.e. a single table, all tables without report body, just the report body).

Method Validation Summary

Sample Analysis reports are expected to contain a table or section that summarizes information from the Method Validation study upon which the assay was validated. GuWu will automatically retrieve this information from the appropriate Watson study (as assigned by the user).

Hooks GuWu can (as a custom modification to GuWu) retrieve data from additional company data stores that contain information needed in a report. For example, Analytical Reference Standard information may be stored in a separate database system. GuWu can retrieve this information to include in a report.

TBR = To Be Released

Gubbs Inc.Creator of software tools that provide data

processing and reporting solutionswww.gubbsinc.com

GuWu features that make life easier for users

Time Benefits of GuWu Report Preparation

Sample Analysis Report preparation can take days

Method Validation Report preparation can take weeks

Report QC Report QC processes are not

eliminated Report QC completion times are

reduced Most format/accuracy items are

performed automatically QC accuracy is enhanced

Reports are delivered more quickly to QA

Report QA Report QA processes are not

eliminated Report QA completion times are

reduced QA is allowed to focus on SOP items

rather than formatting Value accuracy checks proceed much

more quickly since accuracy issues should be eliminated at the QC step

Gubbs Inc.Creator of software tools that provide data

processing and reporting solutions

Cost Benefits of GuWu

Gubbs Inc.Creator of software tools that provide data

processing and reporting solutions

Gubbs Inc.Creator of software tools that provide data

processing and reporting solutionswww.gubbsinc.com

Insert Field Code feature

Eval Outlier featureTable 1. Summary of Cmpd1 Interpolated QC Standard Concentrations

Theoretical Nominal Concentrations QC Low QC Mid QC High

Watson Run ID

3.00 ng/mL

30.0 ng/mL

800 ng/mL

1 3.26 33.5 a 793 3.00 33.4 803 2 3.10 32.5 778 3.05 31.6 803 3 3.75 b 33.8 823 2.70 33.4 851 5 3.21 31.5 769 2.99 33.8 806 6 3.26 31.4 816 3.32 32.2 811 Summary Statistics Excluding Outlier Values

Mean 3.16 32.6 805 SD 0.274 0.998 23.0

%CV 8.7 3.1 2.9 %Bias 5.3 8.7 0.6

n 10 9 10 Summary Statistics Including Outlier Values

Mean 3.16 32.7 805 SD 0.274 0.981 23.0

%CV 8.7 3.0 2.9 %Bias 5.3 9.0 0.6

n 10 10 10 a = Value outside of acceptance criteria (15% Theoretical) and excluded from summary

statistics because the value is a statistical outlier according to the Grubbs Test. b = Value outside of acceptance criteria (15% Theoretical) but included in summary

statistics.

Optional Extended Table Statistics feature

Page Content Specific Table Legends feature

Method Validation Summary feature

Automatic Multiple Analyte in Body Text feature

Note non-breaking space format in Analyte Name to prevent unwanted word-wrap

Note automatic hyperlinks to actual table

1.1. Quality Control Standard Accuracy and Precision

Duplicate quality control (QC) standards at three concentrations were included in each analytical run. In addition, triplicate dilution QCs were included in each of the analytical runs in which dilutions were performed. Summaries of interpolated QC standard concentrations are provided in Table 1 for Compound 1, Table 2 for Compound 2, Table 3 for Compound 3, and Table 4 for Compound 4. The ranges for the mean accuracy, expressed as %bias, and precision, as measured by percent coefficient of variation (%CV) for each analyte are summarized in the following text table.

Mean Accuracy (%Bias) Precision (%CV) Analyte Min Max Table # Min Max Table #

Compound 1 3.3 6.9 1 6.4 10.3 1 Compound 2 4.4 3.6 2 7.3 10.3 2 Compound 3 1.9 1.7 3 6.5 10.0 3 Compound 4 1.9 1.7 4 6.9 12.0 4

Note page content specific legend on page 5 does not appear on page 6