PROSize 3.0. Data Analysis Software

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1 PROSize 3.0 Data Analysis Software

2 New Features Many features you grew to know and like about the PROSize 2.0 Data Analysis Software are still available in the new PROSize 3.0 Data Analysis Software package, along with some exciting new features including: Expandable electropherogram image Adjustable gel/electropherogram sizes during analysis Inclusion Regions - analyze only the portion(s) of the sample you want New DQN (DNA Quality Number) in DNA and NGS analysis modes; a purity-based metric for rapid assessments of sample quality Molarity calculation options; settings to use Peak Maxima or Average Size of a Smear Concentration/Molarity units; view data in ng/µl / nmole/l or in pg/µl / pmole/l % Concentration based on either mass concentration or molarity Image resolution; easily change the exported image resolution to be higher for publication work Y-Axis; set the Y-axis to units of molarity with a simple right-click function X-Axis; set a start time for the data to display Add annotations to the gel image and/or the electropherogram Logo function; add your company logo to reports Recent file viewer; easily load the most recent runs you ve looked at.

3 New Features 21 CFR Part 11 In addition to the above features, PROSize 3.0 now supports 21 CFR Part 11 compatibility, when paired with the Fragment Analyzer Instrument Software version or above. Database structure; allowing for recording of all changes and settings used in the data analysis User management; three different levels of user access available alerts; receive alerts when someone else attempts to use your login esignature; sign and review documents Event reports; track and review changes made to the software Data event log; track and review changes made to a file

4 Main Screen Once data is opened, the main screen appears similar to previous PROSize versions. Notable feature changes are highlighted in the BLUE boxes on the left.

5 A Expandable Electropherogram Image Selection of the BLUE arrow indicated on the left will extend the electropherogram encompassing the entire bottom portion of the screen. To minimize the electropherogram to original size and view the Peak Table select the BLUE arrow again.

6 B X-Axis Electropherogram Start Time Right-clicking on the X-Axis and selecting Set Display Starting Time (min) will open the popup window shown on the right. In this window you can select a new Starting Time to show for the electropherogram view. This will change the view as shown in the next slide.

7 Start time shifted after using the Set Display Starting Time option.

8 C Y-Axis Molarity Right-clicking on the Y-Axis now opens an option to show the Y-Axis in either RFU, a traditional scale based upon sample mass, or in Molarity (nmole/l), which is based upon the relative # of molecules in the sample.

9 7/19/2017 D Gel Image Annotation Hover over the annotation wording to select it and move to the desired location. Hover over the arrow to move the annotation to the desired location. PROSize 3.0 now contains Annotation options for the Gel Image as well as the Electropherogram view. Selection of the icon above the Gel Image will open the Add Annotation box on the top right. Selection of the icon will open the Annotation Editor screen shown on the bottom right allowing you to change colors or edit your annotations.

10 E Option Menu The DQN (DNA Quality Number): A purity-based QC metric available in DNA and NGS modes. Similar to the GQN, this setting can be enabled or disabled, is adjustable by the user, and can be useful for quickly determining if samples are of suitable quality for downstream applications. Molarity Calculation: Set to Use Peak Maxima or Average Size of a Smear. Selection of the Option menu from the top tool bar will open a new Window shown here. Concentration Unit: Settable to the range you are interested in for your samples (ng/µl or pg/µl). % Concentration based on: Setting to base % Conc. value on Mass Concentration or Molarity. Image Resolution: Adjust the exported image resolution higher for publication work. Edit Configuration: Make changes to your Global Configuration if needed.

11 Adjustable Gel/Electropherogram Size Hovering anywhere over the center bar indicated here in blue will display a symbol. You can then leftclick/hold the mouse key and draw the line up or down to increase or decrease the size of the electropherogram relative to the Gel Image size. Examples of each option are shown on the next slide.

12 Adjustable Gel/Electropherogram Size

13 Inclusion Regions Under the Option Edit Configuration window or the Individual Parameters window shown on the left you can now enter Inclusion Regions based on size. When entering a Start and End Size the Peak Table will show only the region(s) of interest. Inclusion Regions can be applied to All or just Selected sample wells.

14 Logo Under the Generate PDF option you can now enter a logo for your company that will be shown at the top of each page of the PDF Report, example below.

15 Recent Files Selection of File-Recent Files will show the most recent files you have opened allowing for quick access to the last few runs you ve viewed.

16 21 CFR Part 11 Compatibility Select the Administration-Configuration option from the top menu bar to show the popup screen on the left. Select Login required to enable Login functions for PROSize. Select 21 CFR Part 11 Enable to enable 21 CFR Part 11 compatibility. In order to view data generated with 21 CFR Part 11 Fragment Analyzer Instrument Software, this option must be enabled. Set Login criteria from this screen as well.

17 21 CFR Part 11 Compatibility - Login Enabling the Login or 21 CFR Part 11 compatibility will allow you to create a new user. After creation the Login screen will open each time you open PROSize allowing the user to login with their individual ID and Password.

18 Once logged in the User ID will show on the top bar of the software as well as showing that 21 CFR Part 11 compatibility is Enabled. Navigation to the Administration User Account Maintenance option will open the User Account Setup window. This window allows for entering new users, passwords, , access level, esignature level and if the user wants to receive notifications.

19 Database files for 21 CFR Part 11 compliance Files generated in the Fragment Analyzer Instrument Software with the 21 CFR part 11 compliance enabled will show as a.db3 database file instead of a folder. All the separation information is inside this folder as well as all Event Reports for the separation.

20 esignature Navigation to the esignature - esign option will open the esign Login window allowing a user to input their ID and password. The user can then esign the separation file as the Author, Reviewer, or Approver as well as enter any description or notes they would like to make for the separation file.

21 7/19/2017 User Manual and Tutorial Videos As in previous PROSize versions, a complete User Manual and numerous Tutorial Videos are available for viewing on demand, under the Help User Manuals and Help - Tutorial Videos options on the main screen. Users are encouraged to view this material to further learn about the various features and functions of the PROSize software.

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