Table of Contents
Section 1 PharmSpec 3 description
...31.1 What is new in PharmSpec 3?...3
1.2 Software components...3
Section 2 Installation
...5 2.1 PC requirements...5 2.2 Software installation...5 2.3 Windows settings...9Section 3 Administration
...11 3.1 Add users...11 3.2 User rights...123.3 Give optional rights to a user...13
3.4 Remove users...14
3.5 Disable an obsolete procedure...15
3.6 Enable a procedure...16
3.7 Backup the database...17
3.8 Archive data...19
3.9 Restore the database...20
3.10 View the activity logs...22
Section 4 Hardware installation
...234.1 9703 sampler...23
4.2 9703+ or 9705 sampler...23
Section 5 Hardware settings
...255.1 9703 or 9703+ sampler...25 5.1.1 Add a sensor...25 5.1.2 Change a sensor...27 5.1.3 Remove a sensor...27 5.1.4 Add a counter...28 5.1.5 Remove a counter...28 5.1.6 Add a sampler...29
5.1.7 Change the sampler settings...29
5.1.8 Remove a sampler...30
5.2 9705 sampler...30
Section 6 Operating parameters
...336.1 Select the sample identifiers for counter tests...34
Section 7 Setup options
...357.1 Check for software and procedure updates...35
7.2 Select report options...36
7.3 Enable warnings...37
7.4 Setup local users...38
Section 8 Operation
...398.1 Log in...39
8.2 User interface...39
8.3 View user rights...39
8.4 Manually operate the sampler...40
8.5 Do a procedural test...40
8.6 Do a counter test...42
8.7 Do an instrument standardization test...42
8.8 Do a test in simulation mode...43
8.10 Review and approve test results in the queue...46
Section 9 Historical reports
...499.1 View, print and/or export historical test reports...49
9.2 Attach an archive database...50
Section 10 License Update
...53Section 11 Procedure Builder
...5511.1 Make a report template...55
11.1.1 Start the report template wizard...55
11.1.2 Enter the report titles...55
11.1.3 Enter the report headers...56
11.1.4 Select the format for test parameters and results...56
11.1.5 Preview the report template...56
11.1.6 Name and save the report template...57
11.2 Make a user-defined procedure...57
11.2.1 Start the procedure wizard...57
11.2.2 Enter the sample identifiers...57
11.2.3 Enter the computational and parameter settings...57
11.2.4 Enter the pass/fail criteria...58
11.2.5 Enter instructions for the procedure...58
11.2.6 Select a report template...58
11.2.7 Name the procedure...58
11.2.8 Review and save the procedure...59
Section 12 Procedure Distributor
...61Section 13 Procedure Loader
...63Section 14 Troubleshooting
...6514.1 Detach and attach the PharmSpec database...69
Section 15 Using the online help
...71Section 16 Using the shortcut keys
...73Index
...75Section 1
PharmSpec 3 description
PharmSpec 3 is a Microsoft® Windows® application that is used with the HIAC liquid
particle counting sensors and the HIAC samplers. PharmSpec collects and analyzes raw data from the liquid particle counting sensors using the USP, EP, JP or KP procedural standards, or user-defined test procedures.
PharmSpec 3 features include:
• Compliance with FDA 21 CFR Part 11 requirements
• Data analysis of single or multiple runs done using the USP<788>, USP<789>, CP, EP, JP and KP procedural standards or user-defined test procedures (up to
16 channels)
• Test results can be reviewed and approved electronically
• Pulse height analyzer (PHA) graph for the last test done (9703 and 9703+ only) • Historical reports can be viewed, printed and exported (PDF, DOC, XLS or CSV) • Historical data backup, restore and archive
• Procedure Builder to make user-defined test procedures and report templates • View Activity Logs function
1.1 What is new in PharmSpec 3?
New PharmSpec 3 features include:
• Compatibility with the HIAC 9703+ Liquid Particle Counting System • Compatibility with MC particle counting sensors
• Users are added to PharmSpec using Windows® User Management
• Users log in to PharmSpec using their Windows user account logins and passwords • Password expirations and lockout settings are selected using Windows
• USP<789> test procedural standards
• Procedural standards and user-defined test procedures can be distributed to other computers by the user
• Partial results are recorded for incomplete tests
• Automatic checks for procedure and software updates can be scheduled by the user • Batch printing and exporting of reports
• Alarms for invalid configuration, calibration due, bubbles detected, concentration limit exceeded, sample probe needs recalibration, sensor blocked and sensor
contaminated
• Number of reviewer signature lines on printed reports is set by the user • Company logo can be added to reports by the user
• FDA 21 CFR Part 11 requirement features can be disabled using a license key (logins, user administration, review and approvals of tests, and audit trails) • Local language support for French, German, Italian and Japanese
• Historical reports (Archives)
• Reports can be displayed in local language or English on non-English systems • 64 bit support for Windows®7, Windows Vista and Windows XP
1.2 Software components
Component Description
License Update Used to upgrade the license key for PharmSpec (refer to
License Update on page 53)
PharmSpec Used to configure the test setup, do tests and show
Component Description
Procedure Builder An optional software component that allows a user to make
user-defined procedures and new report templates (refer to Procedure Builder on page 55)
Procedure Distributor Used to save licensed procedures and user-defined
procedures to a Microsoft Access database file (refer to Procedure Distributor on page 61)
Procedure Loader Used to install licensed procedures and user-defined
procedures on a computer with PharmSpec from a Microsoft Access database file (refer to Procedure Loader
on page 63)
Simulation Application Used to select the pre-defined result values that are used by PharmSpec when tests are done in simulation (demo) mode (refer to Do a test in simulation mode on page 43)
Database Utility Used to restore, backup and archive data.
Section 2
Installation
2.1 PC requirements
The PC requirements shown in Table 1 are the minimum requirements supported. The user may benefit by using a faster processor and/or additional memory. Windows® Vista and Windows 7 users may have higher requirements.
Table 1 PC requirements for PharmSpec 3
Component Requirement
Processor Pentium 1.0 GHz
Operating System Windows XP with Service Pack 3 or later
Windows Vista with Service Pack 2 or later Windows 7 platforms
64 bit for all OS
Memory 512 MB of RAM
Hard disk FN 2 GB of available hard-disk space
Drives A CD drive, DVD drive, USB port or network connection is
required for installation
Display Super VGA video adapter and monitor, 1024 x 768 or higher
resolution
Power supply Uninterruptable power supply (UPS)
Removable drive Removable drive for backing up data, such as a recordable
CD or a network server that can back up the computer hard drive
Printer Color printer capable of printing at 300 dpi
Port 9703+ or 9705: USB port to connect sampler, or
9703: COM port to connect sampler
Software Internet Explorer 6 SP1 or higher
1 Actual requirements can vary based on the system configuration and the applications and features that are installed. Additional hard-disk space may be required.
2.2 Software installation
Pre-requisites:The user must have Windows® Administrator rights on the computer to
install PharmSpec. If logging in to Windows using a domain user account, make sure the network cable is plugged in to the computer and there is a connection to the network. PharmSpec is installed on the computer using an installation wizard. The installation wizard:
• Installs PharmSpec and PharmSpec software components, depending on the license (refer to Software components on page 3)
• Installs SQL Server 2008 and a database file for PharmSpec • Adds four PharmSpec user security groups to the computer • Adds a shortcut icon for PharmSpec to the desktop
Note: A complete installation of the main application (.NET environment and SQL Server database
support) can take up to 45 minutes to complete.
To install the software:
1. Log in to Windows using the Windows user name and password of a Windows
Administrator on the computer.
If Autorun is active on the computer, the installation wizard starts.
3. If the installation wizard does not start, double-click the Setup.exe file on the CD to
start the installation wizard.
4. Select Licensed Mode and click Next.
5. Enter the order number, customer name, and software license key for the software
license.
Note: The software license key can be copied and pasted for accurate entry.
6. Click Next.
7. Select Custom or Complete. The Custom option allows a user to choose which
features and paths are used for the installation. The Complete option installs the software with default paths (the user must still enter a password for the SA account.) The substeps below apply to Custom installations.
a. To continue with a Custom installation, select Components. The Select Features
screen appears.
Figure 1 Select Features screen
b. Click the check boxes to select the features to install.
c. Click Next, or to select a different installation location, click Browse to open the
Choose Destination Location screen.
Figure 2 Choose Destination Location screen
d. Click Next.
If both the application and the database were selected, the database is automatically installed. If SQL was not selected in the Select Features screen, the Select Database Server window opens and steps e and f apply.
Note: In Complete installations, the SQL installation path is fixed to the location
recommended by Microsoft® and cannot be changed. Figure 3 Select database server screen
e. Click Browse to view the list of database servers. Figure 4 Available database servers
f. Highlight a server in the list and click OK. The password window opens.
Figure 5 SQL password screen
g. Enter the SA password in the Password field.
8. Click Next to accept the installation settings and start the installation process.
9. When the installation is complete, the user is given a chance to place the name of the
installer in the PharmSpecAdmins group and to create a CalTech user. Refer to Add users on page 11.
2.3 Windows settings
Set the Windows® display, decimal separator and time and date separator and formats as
shown in Table 2. The user must have Windows Administrator rights on the computer to change the Windows settings.
Table 2 Windows settings
Option Setting
Display settings Set for small fonts
Decimal separator Set correctly for the user (typically either the decimal “.” or comma “,” character)
Date separator and format Set the date separator and format for the short date as the user wants it to be shown in PharmSpec
Time separator and format Set the time separator and format as the user wants it to be shown in PharmSpec
Section 3
Administration
3.1 Add users
A Windows® Administrator on the computer adds users to PharmSpec (and the
PharmSpec software components, such as Procedure Builder) by adding users to the PharmSpec user groups on the computer.
Four PharmSpec user groups are added to the computer during software installation. Each user group has a set of rights (refer to User rights on page 12).
Each user is added to one of the PharmSpec user groups on the computer. A user has the rights of the user group to which they are added. After being added to a user group, a user logs in to PharmSpec using their Windows user name and password.
Note: A Windows user account must have a full name and password before it can be added to a
PharmSpec user group.
To add a user to a user group:
1. Log in to Windows using the Windows user name and password of a Windows
Administrator on the computer.
2. From Windows, click Start. Right-click on My Computer and select Manage.
The Computer Management window opens.
3. Click Local Users and Groups. 4. Double-click Groups.
The four PharmSpec user groups are shown (PharmSpecAdmins,
PharmSpecCalTechs, PharmSpecOperators and PharmSpecSupervisors).
5. Double-click the user group to which a user will be added.
6. Click Add.
The Select Users, Computers, or Groups window opens.
7. Click Locations. To add domain users, select the correct domain name. To add local
users, select the computer name.
8. Enter the Windows user name for the user. 9. Click Check Names.
The first and last name of the user, their Windows user name and domain name are shown.
10. Click OK.
11. Click OK to save the changes and close the window.
3.2 User rights
A Windows® Administrator on the computer gives rights to users by adding each user to
one of the four PharmSpec user groups on the computer (refer to Add users on page 11). Each user group has a set of default rights and optional rights (Table 3).
A user is automatically given the default rights for the user group to which they have been added. A user can also be given one or more of the optional rights for a user group by a PharmSpec Administrator (refer to Give optional rights to a user on page 13).
For information on how to view the rights of each user, refer to View user rights
on page 39.
Table 3 User group rights
Rights Operator Supervisor Calibration Technician Administrator
View Profile x x x x
Run Tests x (optional) x x x
View or Print Reports x x x x
Review Reports x (optional) x x x
Setup Test System x (optional) x (optional) x
Approve Reports x (optional) x
View/Print Activity Logs x (optional) x
Load/Create Procedures x (optional) x
Disable Obsolete Procedures x (optional) x
Options x (optional) x x x
Run Instrument Standardization Tests x (optional) x (optional)
Administration Setup x (optional)1
1 This right is given to Administrators by default. If removed, the Administrator can no longer change their optional rights.
3.3 Give optional rights to a user
A PharmSpec Administrator can give one or more of the optional rights for a user group to a user.
Note: Changes made to the rights of the user that is logged in are not available until the user logs
out of PharmSpec and then logs in to PharmSpec.
To give one or more of the optional rights for a user group to a user:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
Administrator on the computer.
2. Select Setup, Administration. 3. Select the user.
4. Click Modify User Rights.
The rights of the selected user are shown.
5. Select the right to give to the user in the Select Rights field. 6. Click the right arrow button.
The right is shown in the Selected Rights field.
7. To remove an optional right from the user:
a. Select the optional right in the Selected Rights field. b. Click the left arrow button.
The right is shown in the Select Rights field.
8. Click OK. 9. Click Close.
3.4 Remove users
A Windows® Administrator on the computer removes a user from PharmSpec by
removing the user from the PharmSpec user groups on the computer. To remove a user from a user group:
1. Log in to Windows using the Windows user name and password of a Windows
Administrator on the computer.
2. From Windows, click Start. Right-click on My Computer and select Manage.
The Computer Management window opens.
3. Click Local Users and Groups. 4. Double-click Groups.
The four PharmSpec user groups are shown (PharmSpecAdmins,
PharmSpecCalTechs, PharmSpecOperators and PharmSpecSupervisors).
5. Double-click the user group from which a user will be removed.
The PharmSpecxxx Properties window opens.
6. Select the Windows user to remove. 7. Click Remove.
8. Click OK to save the changes and close the window.
3.5 Disable an obsolete procedure
A user with the Disable Obsolete Procedures right can disable an obsolete procedure. When a procedure is disabled:
• The procedure is removed from the Standard Procedures field at the top of the main window.
• The status of the procedure changes from active to obsolete so that the procedure can not be used to do tests.
To disable an obsolete procedure:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Disable Obsolete Procedures right.
2. Select Setup, Disable Obsolete Procedures.
The Disable Obsolete Procedures window opens.
3. Select the procedure in the Active Procedures field. 4. Click the right single arrow button.
The procedure moves to the Obsolete Procedures field.
Note: Click the double arrow buttons to move all procedures from one field to the other.
5. Click OK.
3.6 Enable a procedure
A user with the Disable Obsolete Procedures right can enable a procedure that has been disabled.
When a procedure is enabled:
• The procedure is added to the Standard Procedures field at the top of the main window.
• The status of the procedure changes from obsolete to active so that the procedure can be used to do tests.
To enable a procedure:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Disable Obsolete Procedures right.
2. Select Setup, Disable Obsolete Procedures.
The Disable Obsolete Procedures window opens.
3. Select the procedure in the Obsolete Procedures field. 4. Click the left arrow button.
The procedure moves to the Active Procedures field.
5. Click OK.
3.7 Backup the database
The database utility allows a Windows® Administrator to do a full or quick backup of the
PharmSpec database manually at any time and schedule automatic data backups on a daily, weekly or monthly interval.
The Database Utility is a software component that comes with PharmSpec. Note: Only Windows® Administrators can log in to the Database Utility.
A full backup stores a copy of the entire database in the backup folder. A quick backup stores the changes made to the database since the last backup (either quick or full) in the backup folder.
To backup the database or schedule backups:
1. Log in to Windows using the Windows user name and password of a Windows
Administrator on the computer.
2. From Windows, select Start, All Programs, PharmSpec, Database Utility. 3. Log in to the Database Utility using the Windows user name and password of a
Windows Administrator.
4. Select the Backup tab.
The Backup Configuration window opens.
5. To change the default backup drive:
a. Select the drive where backups should be saved. b. Click OK.
6. To do a full backup now, select Full and click Backup Now. 7. To do a quick backup now, select Quick and click Backup Now. 8. To schedule full backups:
a. Select Full and click Schedule.
The Schedule Backup window opens.
b. Select the days and times when a full backup is done. c. Click OK.
9. To schedule quick backups:
a. Select Quick and click Schedule.
The Schedule Backup window opens.
b. Select the days and times when a quick backup is done. c. Click OK.
10. Close the Database Utility.
3.8 Archive data
A Windows® Administrator can archive all database entries made before a selected date.
Use the Archive feature to remove old entries from the database and save them to the archive folder.
Use the Database Utility to attach the archive database and view archived data in PharmSpec.
1. On the computer, log in to Windows using the Windows user name and password of
a Windows Administrator.
2. From Windows, select Start, All Programs, PharmSpec, Database Utility. 3. Log in to the Database Utility using the Windows user name and password of a
Windows Administrator.
4. Select the Archive tab.
5. To change the default archive folder: a. Click the browse button.
b. Select the folder. c. Click OK.
6. To archive database entries:
a. Select the start date to archive. (The default date is 30 days before the current
date.)
b. Click the Archive folder.
All database entries made before the date selected are removed from the database and saved on the archive drive.
7. Close the Database Utility.
3.9 Restore the database
The PharmSpec database can be restored from the last full or full and quick database backup done (refer to Backup the database on page 17) using the Database Utility. A database restore replaces the current database with the backup database.
The Database Utility is a software component that comes with PharmSpec. Note: Only Windows® Administrators can log in to the Database Utility.
To restore the database from the backup:
1. On the computer, log in to Windows using the Windows user name and password of
a Windows Administrator on the computer.
2. Make sure that PharmSpec, Procedure Builder, Procedure Distributor or Procedure
Loader is not open on the computer.
4. Log in to the Database Utility using the Windows user name and the password of a
Windows Administrator on the computer. The PharmSpec DB Tools window opens.
5. To restore the database using only the last full backup done: a. Select Database (Full Only).
b. Select the full backup file to use to restore the database.
6. To restore the database using the last full backup and any quick backup done since
the last full backup:
a. Select Database (Full + Quick).
b. Select the full backup file and quick backup file to use to restore the database. 7. Click Restore.
The SA password window opens.
Figure 6 SA password screen
8. Enter the password that was entered during the installation procedure.
9. To clear the database log, click Clear DB Log. Do not clear the database log unless
instructed to do so by Technical Services.
10. Click Close to close the window. 11. Restart the computer.
3.10 View the activity logs
A PharmSpec user with the View/Print Activity Logs right can view and print the activity logs.
To view and/or print the activity logs:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the View/Print Activity Logs right.
2. Select Reports, View Activity Logs.
The View Activity Logs window opens. All the activities that have occurred today are shown in the window.
Figure 7 Activity logs screen (partial)
3. To show the activity logs for a specific date/time range, enter the date/time range in
the Date/Time fields and click Apply.
4. To show the activity logs for a specific user, select the user in the User field and click Apply.
5. To show the activity logs for a specific type of activity, select the activity in the Activity
field and click Apply.
6. To print the activity logs shown, click Print. 7. To export the activity log shown, click Export.
The activity log can be exported as a Word, Excel or a comma separated text (CSV) file.
Section 4
Hardware installation
4.1 9703 sampler
Connect the sampler to the computer with PharmSpec:
1. Connect the communication (COM) cable to the sampler and the computer. 2. Turn on the sampler.
4.2 9703+ or 9705 sampler
Connect the sampler to the computer with PharmSpec:
1. Turn on the sampler.
2. Connect the USB cable to the sampler and the computer.
3. If the Windows® Found New Hardware Wizard starts, use the wizard to install the
Section 5
Hardware settings
Select the hardware settings to configure the software for use with the instrument before a test is done. Change the hardware settings when there is a change in the hardware components (i.e. sensor, probe or syringe).
Connect the instrument to the computer with PharmSpec before selecting the hardware settings (refer to Hardware installation on page 23).
5.1 9703 or 9703+ sampler
To select the hardware settings:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Setup Test System right.
2. Select Setup, Hardware Settings.
The Hardware Settings window opens.
3. If Simulation is selected, unselect Simulation and click OK. Click Yes to change to
online mode.
Some fields on the Hardware Settings window are automatically populated, such as the Sampler fields and Counter fields and can not be changed. Some buttons are disabled, depending on the sampler.
4. (9703) In the Communication area of the window, select the communication (COM)
port on the computer that is connected to the sampler cable in the Port field. The default baud rate of 19200 is correct.
5. (9703+) In the Communication area of the window, select USB in the Port field. 6. Add the sensor that is installed in the sampler to the hardware settings (refer to Add a
sensor on page 25).
7. In the Sensor area of the Hardware Settings window, select the model and serial
number of the sensor installed in the sampler.
The Sensor Data area of the window shows the information entered for the sensor selected.
8. (9703) Add the sampler to the hardware settings (refer to Add a sampler
on page 29).
9. (9703) In the Sampler area of the Hardware Settings window, select the model and
serial number of the sampler.
10. (9703+) Change the sampler settings (refer to Change the sampler settings
on page 29).
11. To automatically print test reports after doing a test, select Auto Print On.
12. In the PHA area of the window, select the minimum (XMin) and maximum (XMax)
partical sizes (microns) that are shown on the horizontal axis of the PHA chart. The maximum size should be at least 30 microns larger than the minimum size.
5.1.1 Add a sensor
To add a sensor to the hardware settings (9703 and 9703+ only):
1. Click Sensor in the Add/Modify/Remove area of the Hardware Settings window.
2. To enter the sensor information: a. Select Add.
b. To add a HRLD sensor, select Single in the Calibration Mode field. c. To add an MC sensor, select Dual in the Calibration Mode field.
Fields for two calibration curves are shown: Extinction and Scatter.
d. Enter the sensor information provided on the Certificate of Calibration sheet or
Test Setup Configuration sheet that was included with the sensor. A minimum of four calibration values (size and millivolts) must be entered for each calibration curve.
If there are multiple calibration curves for a sensor due to different flow rates (or other reasons), add a sensor with a different model number (e.g., HRLD-150 at 10 mL or HRLD-150 at 25 mL) for each calibration data set.
Note: If the entered sensor model is not included in the C:/Program
3. To import the sensor information from a file: a. Select Import.
The Import Sensor window opens.
b. Select the file that contains the sensor information. c. Click Open.
The imported sensor information is shown in the fields. The information shown can be changed except for the sensor type, model and serial number.
4. Click Save.
The sensor is added.
5. To clear the sensor fields so another sensor can be added, click Yes. 6. To not clear the sensor fields, click No.
7. Click Close to close the window.
5.1.2 Change a sensor
A PharmSpec user with the Setup Test System right can add/change the sensor details and calibration data for a sensor after the sensor is added to the hardware settings. The sensor type, model and serial number can not be changed.
To add/change the settings for a sensor:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Setup Test System right.
2. Select Setup, Hardware Settings.
The Hardware Settings window opens.
3. Click Sensor. 4. Select Modify.
The Modify Sensor window opens.
5. Select the sensor model and serial number.
6. Add/Change the sensor settings. Enter the sensor calibration information provided on
the Certificate of Calibration sheet or Test Setup Configuration sheet that was included with the sensor. A minimum of four calibration values (size and millivolts) must be added for each calibration curve.
Note: The sensor type, model and serial number can not be changed.
7. Click Save.
The new sensor information is saved.
8. Click OK.
9. Click Close to close the window.
5.1.3 Remove a sensor
A PharmSpec user with the Setup Test System right can remove a sensor from the hardware settings if the sensor is not currently configured as the active sensor in
PharmSpec. The sensor currently configured as the active sensor in PharmSpec can not be selected in the Remove Sensor window.
To remove a sensor from the hardware settings:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Setup Test System right.
2. Select Setup, Hardware Settings.
The Hardware Settings window opens.
3. Click Sensor. 4. Select Remove.
The Remove Sensor window opens.
5. Select the model of the sensor in the Model field.
6. Select the serial number for the sensor in the Serial Number field. 7. Click Remove.
8. Click Yes to remove the sensor. 9. Click OK.
10. Click Close to close the window.
5.1.4 Add a counter
To add a counter to the hardware settings:
1. Click Counter in the Add/Modify/Remove area of the Hardware Settings window.
The Add Counter window opens.
2. Enter the counter model in the Model field.
3. Enter the counter serial number in the Serial Number field. 4. Click Save.
5. Click Close to close the window.
5.1.5 Remove a counter
A PharmSpec user with the Setup Test System right can remove a counter from the hardware settings if the counter is not connected to PharmSpec. The counter that is connected to PharmSpec can not be selected in the Remove Counter window. To remove a counter from the hardware settings:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Setup Test System right.
2. Select Setup, Hardware Settings.
The Hardware Settings window opens.
3. Click Counter.
The Add Counter window opens.
4. Select Remove.
The Remove Counter window opens.
5. Select the model of the counter in the Model field.
6. Select the serial number for the counter in the Serial No. field. 7. Click Remove.
8. Click Yes to remove the counter. 9. Click OK.
5.1.6 Add a sampler
To add a sampler to the hardware settings (9703 only):
1. Click Sampler in the Add/Modify/Remove area of the Hardware Settings window.
The Add Sampler window opens.
2. Enter the model of the sampler.
3. Enter the serial number for the sampler.
4. Select the size of the syringe installed in the sampler. 5. Select the size of the probe installed in the sampler.
6. To have the arm automatically lift after a test is complete or after each run: a. Select Lift Arm.
b. Select Lift arm after test completed or select Lift arm after each run. 7. Click Save.
The sampler is added.
8. To clear the sampler fields so that another sampler can be added, click Yes. 9. To not clear the sampler fields, click No.
10. Click Close to close the window.
The Sampler Data (Current Setup) area of the window shows the syringe size and probe size selected.
5.1.7 Change the sampler settings
A PharmSpec user with the Setup Test System right can add/change the settings for a sampler (different size probe or syringe, etc.) after the sampler is added to the hardware settings (9703 and 9703+ only).
Note: A 9703+ sampler is automatically added to the hardware settings. To change the hardware settings for the sampler:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Setup Test System right.
2. Select Setup, Hardware Settings.
The Hardware Settings window opens.
3. Click Sampler in the Add/Modify/Remove area of the Hardware Settings window.
The Add Sampler window opens.
4. (9703) Select Modify.
The Modify Sampler window opens.
5. (9703) Select the model of the sampler.
6. (9703) Select the serial number for the sampler. 7. Select the size of the syringe installed in the sampler. 8. Select the size of the probe installed in the sampler.
9. To have the arm automatically lift after a test is complete or after each run: a. Select Lift Arm.
b. Select Lift arm after test completed or select Lift arm after each run. 10. Click Save and then OK.
11. Click Close to close the window.
The Sampler Data (Current Setup) area of the window shows the syringe size and probe size selected.
12. If the probe size was changed, reset the minimum height of the probe to the sampler
container using the front panel controls on the sampler before starting a test (refer to the sampler user manual).
5.1.8 Remove a sampler
A PharmSpec user with the Setup Test System right can remove a sampler from the hardware settings if the sampler is not currently configured as the active sampler in PharmSpec. The sampler currently configured as the active sampler in PharmSpec can not be selected in the Remove Sampler window.
To remove a sampler from the hardware settings:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Setup Test System right.
2. Select Setup, Hardware Settings.
The Hardware Settings window opens.
3. (9703+ and 9705) In the Communication area of the window, select any one of the
COM ports in the Port field.
4. Click Sampler in the Add/Modify/Remove area of the Hardware Settings window.
The Add Sampler window opens.
5. Select Remove.
The Remove Sampler window opens.
6. Select the model of the sampler in the Model field.
7. Select the serial number for the sampler in the Serial Number field. 8. Click Remove.
9. Click Yes to remove the sampler. 10. Click OK.
11. Click Close to close the window.
5.2 9705 sampler
To select the hardware settings:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Setup Test System right.
2. Select Setup, Hardware Settings.
The Hardware Settings window opens.
Some fields on the Hardware Settings window are automatically populated, such as the Sensor, Counter and Sampler fields, and can not be changed. Some buttons are disabled.
4. In the Communication area of the window, select USB in the Port field.
5. Add the calibration information for the sensor currently installed in the sampler to the
hardware settings (refer to Change a sensor on page 27).
The Sensor Data area of the window shows the information entered for the sensor.
6. To automatically print test reports after doing a test, select Auto Print On.
Section 6
Operating parameters
Select the operating parameters before a test is done. The operating parameters selected are used for the Run counter test. The tare volume values selected are also used for standard test procedures and instrument standardization tests.
PharmSpec gets data from the instrument using the operating parameters selected and saves the data in the database. Data analysis is done according to the particle distribution and the pass/ fail classifications of the test procedures.
To select the operating parameters and tare volume values:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Setup Test System right.
2. Select Setup, Hardware Settings.
3. In the Operating Parameters area of the Hardware Settings window, click Modify.
The Operating Parameters window opens.
4. Enter the operating parameters (sample volume, number of runs, particle size(s)
monitored, etc.)
Value Description
Tare volume A volume that is drawn before the sample volume.
A tare volume is drawn on the first stroke of the first run of a test to remove any fluids in the tubing from the last run (or bubbles if the tubing is empty).
Pulling a tare volume makes sure that the sample data obtained is only from the fluid from the sample container currently on the sampler.
Multi-stroke tare
A volume that is drawn between strokes only when multiple strokes are necessary to complete the sample. A multi-stroke tare volume brings the sample fluid up to speed before counting starts.
5. To not use the data for the first run, select Discard First Run.
6. To open the Operating Parameters window at the start of each counter test so that
the operator can make sure that the settings are correct for the test to be started, select Show this screen at the beginning of each test.
7. Click OK.
6.1 Select the sample identifiers for counter tests
To select the sample identifiers that are entered at the start of a counter test:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Setup Test System right.
2. Select Setup, Hardware Settings.
3. In the Operating Parameters area of the Hardware Settings window, click Field Names.
4. Enter the number of sample identifier fields to include-0 to 6.
5. Enter a sample identifier label in each field, such as Lot ID and Batch ID. 6. Click OK.
Section 7
Setup options
7.1 Check for software and procedure updates
Pre-requisites: The computer must be connected to the internet to do a software and
procedure update check and to download updates. A PharmSpec user with the Options right can:
• Check for software and procedure updates manually at any time
• Select a schedule for software and procedure updates checks to be done by the software
• Download software and procedure updates to the computer
Note: Only a Windows® Administrator on the computer can install software and procedure updates
on the computer.
To check for updates now, schedule update checks and/or download updates:
1. Log in to PharmSpec using the Windows user name and password of a PharmSpec
user with the Options right.
2. Select Setup, Options.
The Update Scheduler tab in the Options window opens.
3. To change the default location for downloads: a. Click Browse.
b. Navigate to the folder where updates should be downloaded and select the
folder.
c. Click OK.
4. To schedule an update check to be done when PharmSpec is started, select Check
for updates at program startup.
The Update Viewer window opens when an update check is done.
5. To schedule daily, weekly or monthly update checks: a. Select Check for updates.
b. Select Daily, Weekly or Monthly.
e. (Monthly) Select the day of the month for the update check.
The Update Viewer window opens when an update check is done.
6. To check for updates now, click Check for Updates Now.
The Update Viewer window opens and lists the updates.
7. To download updates, select Download in the Action field for each update to
download and click OK.
The selected updates are downloaded to the computer.
7.2 Select report options
A PharmSpec user with the Options right can:
• Change the number of blank signature lines for Reviewers on printed reports • Change the location of the sample identification values on reports
• Add a company logo to reports
Note: Changes made to the report options only apply to new test reports, not existing test reports. To select report options:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Options right.
2. Select Setup, Options. 3. Click the Reports tab.
The Reports tab of the Options window opens.
4. Select the number of blank signature lines for reviewers on printed reports-0 to 5. 5. Select where sample identification values are located on reports-left or right side. 6. To add a company logo to reports:
a. Select Add company logo to reports. b. Click Browse.
c. Select the image file to add to reports and click Open.
d. Select where the company logo is located on reports-left or right side.
The company logo is automatically reduced in size to fit in the window.
7. Click OK.
7.3 Enable warnings
A PharmSpec user with the Options right can: • Enable or disable individual software warnings • Schedule sensor calibration warnings
Note: All warnings are disabled by default.
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Options right.
2. Select Setup, Options.
3. Click the Errors and Warnings tab.
The Errors and Warnings tab of the Options window opens.
4. To enable a warning, select the checkbox for the warning. 5. To enable and schedule sensor calibration warnings:
a. Select Warn when the sensor needs to be calibrated.
b. Select the calibration warning period (the number of days before a calibration is
due to start warnings).
c. Select the calibration warning interval (the number of days between warnings). 6. Click OK.
7.4 Setup local users
Reasons to set up local users include:
• Operation of the 9703+ when not on a VPN • Operators do not have domain accounts • Additional users are required
1. Click the Start menu and select Help and Support. 2. In the search box, type Create a new user account.
Instructions for setting up a local user will appear.
3. Follow the instructions to set up local user accounts for the OS type.
4. Add the user to the appropriate PharmSpecAdmins group. Refer to Add users
on page 11
Section 8
Operation
8.1 Log in
To log in to PharmSpec or a PharmSpec software component (i.e. Procedure Loader), enter the Windows® user name and password of a PharmSpec user.
Contact a Windows Administrator on the computer to be added as a PharmSpec user.
8.2 User interface
To start PharmSpec, select Start, All Programs, PharmSpec, Pharmspec. Then, log in to PharmSpec using the Windows® user name and password of a PharmSpec user.
The main window of PharmSpec is shown in Figure 8.
Figure 8 PharmSpec main window
1 Toolbar 4 Status bar–software mode (simulation or online)
2 Standard Procedures field–procedural test selected 5 Status bar–status messages 3 IST Standards field–IST procedure selected
8.3 View user rights
User rights are set for each user by a Windows® Administrator on the computer (refer to Add users on page 11). User rights determine which menus in PharmSpec and which PharmSpec software components a user can use.
1. Log in to PharmSpec using the Windows user name and password of a PharmSpec
Administrator on the computer.
2. Select Setup, Administration.
3. Select a user and click Modify User Rights to view their user rights.
8.4 Manually operate the sampler
A user can manually operate a 9703 or 9703+ sampler using PharmSpec.
To manually operate the sampler, select Setup, Sampler Control. The Sampler Control window opens.
Click a button in the window to do the function. The button functions are shown in
Table 4.
Table 4 Sampler control buttons
Button Function
Load syringe Extends the syringe plunger so a user can load or unload a syringe.
Prime Draws the sample in to the sampler to remove air and to make sure that the sample is in the sensor when counting starts.
Flush (9703) A back flush is done with one syringe pull.
(9703+) The user selects a forward flush or back flush and the number of syringe pulls done per forward flush or back flush.
Back flush—reverses the sample flow through the sampler to remove a blockage in the sensor or probe. Forward flush (9703+ only)—pulls the sample flow through the sampler to flush the sensor and can be used to flush a cleaning liquid through the instrument to clean the instrument.
Arm Up Raises the sensor arm so that a user can remove or change of the sample. Versions Shows the sampler and counter version.
Abort/Stop Cancels the current manual sampler operation. Close Closes the Sampler Control window.
Help Opens the online help for the Sampler Control window.
8.5 Do a procedural test
A PharmSpec user with the Run Test right can do a procedural test. To do a procedural test:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Run Test right.
2. Select the procedure to do in the Standard Procedures field at the top of the main
window.
3. Select Sample Test, Run Procedural Test or push F7.
The Sampler Identification window opens.
4. Enter the sample identification value(s) for the sample to be used.
Note: The sample identification fields shown are specific to the test procedure and can not be
changed. 5. Click Continue.
6. Do the steps in the Description field. 7. Change the test parameters as necessary.
Each parameter field shows a default value. The parameters can be changed within the limits set in the procedural test.
8. Click Start.
The test results are shown in the Results area of the window. The test outcome (PASS or FAIL) is shown at the bottom of the Results area of the window when all the test runs are done.
9. To stop a test, click Stop.
10. To electronically review or review and approve the test results now (user with Review
Tests and/or Approve Tests rights):
a. Click Review/Approve.
b. Enter comments and click Review.
c. Enter the Windows user name and password of a PharmSpec user with the
Review Reports right.
d. Click OK.
e. To allow another review, click Exit and then Close. Select Review and Approve.
Refer to Review and approve test results in the queue on page 46.
f. To approve the test results, enter comments and click Approve. Once the test results are approved, no more reviews can be added.
g. Enter the Windows user name and password of a PharmSpec user with the
Approve Reports right.
h. Click OK. i. Click Exit.
11. To electronically review and approve the test results later, click Queue.
12. If the test is an informal test that does not have to be reviewed or approved, click Save Only.
13. To save the test results so they can be printed later and then signed, click Save Only.
14. To print the test report, click Print.
• If the test results have been reviewed or reviewed and approved electronically, the report prints with the electronic signature(s) and the comment(s).
• If the test results have been saved by selecting Save Only, the report prints with blank reviewer and approver signature lines.
• If the test results are in the queue, the report prints without signature lines or electronic signatures.
Note: The software can be configured to automatically print reports after each test (refer to
9703 or 9703+ sampler on page 25).
15. To prepare the instrument to sample using the remote user interface on the sampler
(9705 only), click Remote. Prepare the instrument to take a sample. Push Start on
the remote user interface to start the test. When the test is done, the test results are shown on PharmSpec.
The Remote button is disabled if the sampler does not have a remote user interface.
16. To do another procedural test, click Clear. Then click Run Test. 17. Click Close to close the window.
8.6 Do a counter test
A PharmSpec user with the Run Test right can do a counter test.
A counter test is not a procedural test, so no Pass/Fail results are shown. To do a counter test:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Run Test right.
2. Select the operating parameters for the counter test (refer to Operating parameters
on page 33).
3. Select Sample Test, Run Counter or push F9. 4. Enter a sample identification value(s) in the field(s).
Note: The Sample Identification window does not open if zero sample identification fields were
selected by the user (refer to Select the sample identifiers for counter tests on page 34). 5. Click Continue.
The Run Counter window opens and the test report is shown.
6. To print the test results report, click Print.
7. To prepare the instrument to sample using the remote user interface on the sampler
(9705 only), click Remote. Prepare the instrument to take a sample. Push Start on the remote user interface to start the test. When the test is done, the test results are shown on PharmSpec.
The Remote button is disabled if the sampler does not have a remote user interface.
8. To do another counter test, click Run Test. 9. Click Close to close the window.
8.7 Do an instrument standardization test
A PharmSpec user with the Run Instrument Standardization Tests right can do the instrument standardization test (IST) procedures that are included with the license. IST procedures are calibration and/or verification tests. Refer to the instrument service manual for the calibration procedures.
Note: The Moving Windows and Sensor Resolution instrument standardization tests can not be
done with an MC series sensor.
To do an IST procedure:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Run Instrument Standardization Tests right.
2. Select the IST procedure to do in the IST Standards field at the top of the main
window.
3. Select Sample Test, Run IST or push F2.
The Sampler Identification window opens.
4. Enter the sample identification value(s) for the sample to be used.
Note: The sample identification fields shown are specific to the test procedure and can not be
changed. 5. Click Continue.
Each parameter field shows a default value. The parameters can be changed within the limits set in the test. The most common parameters for a test are sample volume and the number of runs.
8. Click Run Test.
The test results are shown on the Results field.
9. To stop a test, click Stop.
10. To electronically review or review and approve the test results now (user with Review
Tests and/or Approve Tests rights):
a. Click Review/Approve.
b. Enter comments and click Review.
c. Enter the Windows user name and password of a PharmSpec user with the
Review Reports right.
d. Click OK.
e. To add another reviewer, click Exit and then Close. Select Review and Approve.
Refer to Review and approve test results in the queue on page 46.
f. To approve the test results, enter comments and click Approve. Once the test results are approved, no more reviews can be added.
g. Enter the Windows user name and password of a PharmSpec user with the
Approve Reports right.
h. Click OK. i. Click Exit.
11. To electronically review and approve the test results later, click Queue.
12. If the test is an informal test that does not have to be reviewed or approved, click Save Only.
13. To save the test results so they can be printed later and then signed, click Save Only.
14. To print the test report, click Print.
• If the test results have been reviewed or reviewed and approved electronically, the report prints with the electronic signature(s) and the comment(s).
• If the test results have been saved, the report prints with blank reviewer and approver signature lines.
• If the test results are in the queue, the report prints without signature lines or electronic signatures.
Note: The software can be configured to automatically print reports after each test (refer to
9703 or 9703+ sampler on page 25).
15. To prepare the instrument to sample using the remote user interface on the sampler
(9705 only), click Remote. Prepare the instrument to take a sample. Push Start on the remote user interface to start the test. When the test is done, the test results are shown on PharmSpec.
The Remote button is disabled if the sampler does not have a remote user interface.
16. To do another procedural test, click Clear. Click Run Test. 17. Click Close to close the window.
8.8 Do a test in simulation mode
Standard, user-defined and some IST test procedures, and counter tests can be done in simulation (demo) mode. In simulation mode, the parameters and ranges for the
simulated data that is used by Pharmspec are set by the user using the Simulation Application. The number of size channels and the size label for each channel is set in the operating parameters.
The Simulation Application is an additional software component that comes with PharmSpec.
To do a test in simulation mode:
1. In PharmSpec, select Setup, Hardware Settings.
The Hardware Settings window opens.
2. Select Simulation in the top-left corner of the window and then click OK. 3. Select Setup, Hardware Settings and then click Modify to open the Operating
Parameters window.
4. Set the number of size channels and the size label for each channel in the Operating
Parameters window and then click OK.
5. From Windows®, select Start, All Programs, PharmSpec, Simulation Application.
The Simulation Application window opens.
6. To do a test using random, simulated channel counts, select Random Numbers. 7. To do a test using fixed channel counts:
a. Select Fixed Numbers.
b. Select the number of run simulations to use for the test in the Number of
Simulations field. Up to 10 sequential simulations can be selected.
Note: If the number of run simulations selected is less than the number of runs done by
the test, the run simulations that are selected (e.g., Simulation 1 and Simulation 2) are used again until all the runs for the test are completed. For example, if the number of run simulations selected is 2 and the test does 4 runs, Simulation 1 is used first, Simulation 2 is used second, Simulation 1 is used third and Simulation 2 is used fourth.
c. Select 1 in the Select Simulation field.
d. Enter the channel counts for Simulation 1. Up to 16 channels can be entered for
each simulation.
Note: The channel counts are the differential count. PharmSpec calculates the cumulative
e. Enter the channel counts for the rest of the run simulations shown in the Select
Simulation field.
Note: The run simulations shown in the Select Simulation field depends on the number of
simulations selected in the Number of Simulations field. For example, if 4 simulations are selected in the Number of Simulations field, Simulation 1, Simulation 2, Simulation 3 and Simulation 4 are shown in the Select Simulation field.
8. Click Save.
9. In PharmSpec, do the test.
10. To do the test again using less simulations:
a. Change the number of simulations selected in the Number of Simulations field in
the Simulation Application. For example, change the number of simulations from 4 to 2. If 2 simulations are selected, only Simulation 1 and Simulation 2 will be used.
b. Click Save.
11. To do the test again using more simulations:
a. Change the number of simulations selected in the Number of Simulations field in
the Simulation Application. For example, change the number of simulations from 2 to 4.
b. Enter the channel counts for each run simulations shown in the Select Simulation
field.
c. Click Save.
8.9 View the pulse height analyzer graph
A PharmSpec user with the Run Tests right can view the pulse height analyzer (PHA) graph for the test (run counter, procedure or instrument standardization test) that was done last on a 9703 or 9703+ sampler.
Note: The minimum and maximum values shown on the horizontal axis of the PHA graph are
selected by the user (refer to 9703 or 9703+ sampler on page 25).
To view the PHA graph for the test done last:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Run Tests right.
2. Select Sample Test, PHA.
The PHA window opens.
3. To view the millivolt response for a specific particle size, drag the red vertical line to
that area of the graph.
The millivolt response value is shown in the bottom-right corner of the window. Note: The sensor calibration data entered by the user effects the millivolt response value
shown. If the sensor calibration data entered is not correct for the sensor being used, incorrect values are shown.
4. To zoom in on one area of the graph, click and drag a box around the area to view. 5. To show the whole graph again, click Zoom Out.
6. To view differential counts on the graph, select Differential Counts per mL. 7. To view cummulative counts on the graph, select Cummulative Counts per mL. 8. To view the results in log format, select Log.
9. To view the results in linear format, select Linear. 10. To print the graph as currently shown, click Print. 11. Click Close to close the window.
8.10 Review and approve test results in the queue
A PharmSpec user with the Review Reports right can electronically review test results. A PharmSpec user with the Approve Reports right can electronically approve test results. To electronically review and/or approve test results in the queue:
1. Log in to PharmSpec using the Windows® user name and password of a PharmSpec
user with the Review Reports right.
2. Select Review and Approve.
Test results that have not been approved are shown in the Select Test Result field.
3. Expand the test procedures (click +) to show the test results for the procedure that
have not been approved.
4. Select the test results to review and/or approve.
The results for the selected test are shown in the Results Details field. If the test results have been reviewed, the name of the reviewer(s), the review comments, and the date the review(s) was done are shown in the Review Details field.
5. To add a review to the test results selected: a. Enter comments and click Review.
Note: The Review button is enabled only if less than four users have reviewed the
selected test results.
b. Enter the Windows user name and password of a PharmSpec user with the
Review Reports right on the computer.
c. Click OK.
The comments and electronic signature of the reviewer are added to the report. The Review button is disabled.
6. To add another review to the test results selected: a. Click Close to close the window.
b. Select Review and Approve to open the window again. c. Select the test results to review.
d. Enter comments and click Review.
Note: The Review button is enabled only if less than four users have reviewed the
selected test results.
e. Enter the Windows user name and password of a PharmSpec user with the
Review Reports right on the computer.
f. Click OK.
The comments and electronic signature of the reviewer are added to the report. The Review button is disabled.
7. To approve the test results selected: a. Enter comments and click Approve.
Note: The Approve button is enabled only if the selected test results have been reviewed
by at least one user and the test results have not been approved.
b. Enter the Windows user name and password of a PharmSpec user with the
Approve Reports right on the computer.
c. Click OK.
The comments and electronic signature of the approver are added to the report. The approved test results are no longer shown in the Select Test Result field.
8. Click Close to close the window.
Section 9
Historical reports
9.1 View, print and/or export historical test reports
A PharmSpec user with the View or Print reports right can view, print and/or export historical test reports. Test reports can be batch printed and/or exported.
Note: Historical test reports that are in the queue for electronic approval and have not been
approved can not be printed or exported.
To view, print and/or export a historical test report(s):
1. Log in to PharmSpec using the Windows user name and password of a PharmSpec
user with the View or Print reports right.
2. Select Reports, Historical Reports.
The Historical Reports window opens.
3. Select the search criteria for the test report(s) to be viewed, exported and/or printed: a. Select the type of test in the Test field.
b. Select the test procedure in the Test Procedure field.
c. Select a start date for the date range in the Starting Date field. d. Select an end date for the date range in the Ending Date field.
e. To add a sample identifier to the search filter, select the sample identifier in the
Sample ID field. Enter a sample identifier value in the Value field.
f. To add a user name to the search filter, select a user name in the Operator field.
4. Click Apply.
The test report(s) that meets the search criteria is shown. The date/time information and the name of the user that did the test are shown for the report(s).
5. To view a test report, select the report and click View or double-click the report. 6. To print one test report, select the report and click Print.
7. To print more than one test report, select the checkbox for each report to print. Click Print.
8. To save one test report to the computer or a network drive, select the report. Click Export.
9. To save more than one test report to the computer or a network drive, select the
checkbox for each report to export. Click Export.
10. To View, Print or Export reports from an Archive, select the Use Archive Database
check box and enter the search criteria.
Note: An archive database must be attached before the check box becomes active.
9.2 Attach an archive database
An archived database allows retrieval of historical report and audit trail information. An archive database must be attached before reports from an archive can be viewed, printed or exported. A database can be archived through the Database Utility software
component supplied with PharmSpec.
1. On the computer, log in to Windows® with the Windows user name and password of a Windows Administrator.
2. Make sure that PharmSpec, Procedure Builder, Procedure Distributor or Procedure
Loader are not open.
3. From Windows, select Start, All Programs, PharmSpec, Database Utility. 4. Log in to the Database Utility using the Windows user name and password of a
Windows Administrator.
The PharmSpec DB Tools window opens.
Figure 9 Attach Archive screen
6. Browse to the location of the archive file and select it.
Figure 10 Archive selection screen
7. Click Open to attach the archive file.
Section 10 License Update
A user can update the PharmSpec license key that is installed on the computer using the License Update application.
The License Update application is a software component that comes with PharmSpec. Install an updated software license key to:
• Upgrade the license mode (even if PharmSpec was installed in Demo mode). • Add software plug-in modules or standard procedures
To start the License Update application, select Start, All Programs, PharmSpec, License Update. The License Update window opens.
The License Update window shows the current status of installed modules/components and the license mode (licensed or not licensed).
To update the PharmSpec license key:
• If PharmSpec was installed in Demo mode, enter the Sales Order Number, Customer Name and the license key in the fields and then click Upgrade.
• If PharmSpec is licensed on the computer, enter the new license key in the field and click Upgrade.
The License Update application validates the license key, and the sales order number and customer name if entered. If the license key entered is valid, the License Update application updates the license of PharmSpec. If the license key entered is invalid, an error message is shown.
