Product DatasheetOctet CFR Software V12.X andSoftware Validation Package®

Confident 21 CFR Part 11ComplianceOctet® CFR Software Version 12.X
Recent enhancements to our Octet® CFR Software version
12.X and the Sartorius FB Server Monitor Module, along with
software validation package enable all Octet® instruments tobe integrated seamlessly into GxP regulated environments.

Primary Data Integrity
The integrity of raw data is a primary design considerationof Octet® CFR Software. All data acquired using Octet®
Acquisition CFR Software is time stamped and traceable tothe user who initiated data acquisition. Acquired data is
digitally signed and any modification invalidates the data andprevents it from being opened in Octet® CFR Software. Boththe method file containing experiment settings and theexperiment files contains data and analysis settings are
digitally signed to protect data integrity.

Controlled Access with
Multiple User LevelsOctet® CFR Software controls the access of all features thatcan be used to create or modify users, and acquire, modifyand analyze data, including exporting and saving results. The
Administrator manages all users and sets user permissions
based on their authorization level. Four user levels | groups –Administrator, Supervisor, Developer and Lab User – areavailable with default permissions. Each user or user groupmay be customized based on your company’s requirements.
Beginning with Octet® Software version 12.1, the applications have been renamed. The DataAcquisition Software has been renamed Octet® BLI Discovery. The Data Analysis HT Software
has been renamed Octet® Analysis Studio Software.

Enhanced Audit Trail
More actions are logged into the Audit Trail, including anymodifications to an existing method file, preprocess
settings changes such as reference sensors | wells andinterstep corrections, and analysis settings changes suchas curve fits. Octet® CFR Software automatically generates
timestamped Audit Trails, recording transactions thatcreate, delete, or modify electronic records. In eachinstance, the Audit Trail records the date and time of thetransaction, the computer and project name, the user ID,
and information on the action performed. Additional
information such as old and new values for most acquisition
parameters and analysis settings are also added to theAudit Trail. Octet® Analysis Studio Software also has anoption to require users to enter comments or notes for each
Audit Trail event. Once logged, the Audit Trail cannot bedeleted. Audit trails can be filtered by experiment, user,machine, project or date for viewing and subsequently
printed into a PDF document.

Electronic Signaturesmodification. Administrators can enable user permission toallow removal of signatures. These actions are also captured
in the Audit Trail.

Full Control for Routine Assays
and Speed up Analysis
Once method files and data analysis settings are set, they
can be saved and reloaded to new datasets for routine
assays. This feature enables locking the methods andanalysis settings for regulated labs and significantly reduces
analysis time.

Customized Reports
Once analysis is complete, customized reports can becreated by combining various data elements such asgraphs, text, data tables, company logo, images andexperimental details. Reports can then be printed orsaved as PDFs, and uploaded to an electronic notebook
or stored in the database. Report templates can belocked and reloaded to create similar reports foradditional datasets.

Users can access and electronically sign the experiment
data after completing analysis. When an experiment dataset
is signed twice, it completely locks the dataset from furtherFigure 1: Octet® Analysis Studio CFR Software’s new Security tab. User info, including username and privileges, are on the left panel.
Audit Trail details are in the middle and the old vs. new values are on the right panel on the Security tab.
2

Software Validation Package
For researchers working in GLP or GMP laboratories, theOctet® Software Validation Package provides the mostcomprehensive documentation and tools available tovalidate the Sartorius FB Server Monitor and Octet® CFR
Software features and functions.

Shorten Validation Timeto Just Three Days
Ensuring the consistency, quality, and integrity of yourexperiments is of utmost importance, but it can also takeseveral months to adequately certify and document
experimental test procedures and data output. The Octet®
Software Validation Package trims validation time to justthree days using a fully-integrated electronic manual thatmirrors the validation process in a regulated laboratory.

Authenticate Calculations
with Third Party SoftwareStreamline confirmation of Octet® data acquisition andanalysis features using a step-by-step instructions guide.
When testing the Sartorius FB Server Monitor functions,the guide walks you through verifying multiple functions
such as password expiry, inactivating user, automatic user
logout, and new user creation. In addition, the guide covers
how to verify basic pre-processing calculations andquantitation and kinetics curve fits using external software.
Sample data sets are provided to shorten the timenecessary to authenticate and compare analysis algorithms
using Octet® CFR Software to traditional programs including Microsoft® Excel® and GraphPad Prism.

----System Requirements
Windows 10, 32-bit or 64-bitOctet® CFR Software version 12.0 and above
GraphPad Prism version 5.0.4 (optional)
Microsoft Excel 2016 and above

Validation Package Contents
Details on Octet® CFR Software features for implementation of FDA 21 CFR Part 11-compliance requirements
Instructions for installation qualification of the Sartorius
FB Server Monitor software and Octet® CFR Software
Detailed operational qualification sections with:
Instructions and templates for testing routine
calculations and important curve fits
Test files for result confirmation in .xlsx (Excel), .pzm
(Graph Pad Prism), .efrd (Octet® analysis settings) andfrd files (Octet® data)--OQ Test 1: 4PL Unweighted Fit
Purpose: To use previously acquired data to test the curve
fit results for 4PL Unweighted.
Required Files: Located in the Quantitation Tests folder,in the Data and 4PL Unweighted folders.

Table 1: 4PL Unweighted Fit. Step-by-step instructions for verifying Octet® Software 4PL unweighted quantitation curve fit with Graphpad Prism fit inthe Software Validation Package User Guide.

StepActionExpected Results

1Launch Octet Analysis Studio Software if it is not already runningand log on as required. Make sure the Experiment Explorer window
is displayed. If not, click Explore in the Home tab.

The Octet Analysis Studio Software Home screen is displayed showing the Experiment Explorer window.

2

In Experiment Explorer, browse to Data in the Quantitation Tests
folder and double click to open.

Data traces are displayed.

3

In the Home tab, click Load (Analysis Settings).

The Import Settings dialog displays asking if you want tooverwrite settings.

4

Click OK to dismiss the dialog and overwrite existing
analysis settings.

5Browse to the 4PL Unweighted folder,select 4PL Unweighted.efrd and click Open.

A dialog appears indicating that analysis settings havebeen imported.

6

Select the Quantitation Analysis tab and in the Export options
at the top of the screen, click Excel Export.

The Report Selection dialog is displayed.

7

Verify that Standard Curve Table is checked(other selections are optional).

®

Yes | No

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N/A

N/A3

StepAction

Expected Results

8

In the Save to field, browse to the 4PL
Unweighted folder and click Open. Click Save, then click Export.

Results are exported into a file entitled
ExcelReport_[date-time].xls.

9Open ExcelReport_[date-time].xls, then in the Standard Curve
worksheet, type Ctrl+A to select all.

Standard curve contents become selected.

10

Copy the worksheet by typing Ctrl+C.

Results are copied onto the clipboard.

11

Browse to the Quantitation Tests folder and open
4PL Unweighted Validation.xlsx.

12

Select the Analysis Studio Software worksheet. Click on cell A1
and type Ctrl+V to paste the contents of the clipboard.

The Analysis Studio Software results are pasted into theworksheet.

13

Select the Validation Worksheet and inspect theOUTCOME results.

All results are Pass.

14

Save 4PL Unweighted Validation.xlsx with a new name and close it.

N/A

Ordering Information
Part No.

Description

50-0296

Octet® CFR Software V12.X Validation Package

50-5093

Octet® CFR V12.X Software Module

Germany
Sartorius Lab Instruments GmbH & Co. KG
Otto-Brenner-Strasse 2037079 Goettingen
Phone +49 551 308 0

For further contacts, visit

www.sartorius.com/octet-support

Specifications subject to change without notice.
Copyright Sartorius Lab Instruments GmbH & Co. KG.
For Research Use Only.
41-0295 Rev D

Yes | NoUSA
Sartorius Corporation
565 Johnson Avenue
Bohemia, NY 11716
Phone +1 888 OCTET 75
Or +1 650 322 1360

N/A