DOC PharmSpec 3. Software Manual. 10/2013, Edition 3

Transcription

1 DOC PharmSpec 3 Software Manual 10/2013, Edition 3

2

3 Table of Contents Section 1 PharmSpec 3 description What is new in PharmSpec 3? Software components...3 Section 2 Installation PC requirements Software installation Windows settings...9 Section 3 Administration Add users User rights Give optional rights to a user Remove users Disable an obsolete procedure Enable a procedure Backup the database Archive data Restore the database View the activity logs...22 Section 4 Hardware installation sampler or 9705 sampler...23 Section 5 Hardware settings or sampler Add a sensor Change a sensor Remove a sensor Add a counter Remove a counter Add a sampler Change the sampler settings Remove a sampler sampler...30 Section 6 Operating parameters Select the sample identifiers for counter tests...34 Section 7 Setup options Check for software and procedure updates Select report options Enable warnings Setup local users...38 Section 8 Operation Log in User interface View user rights Manually operate the sampler Do a procedural test Do a counter test Do an instrument standardization test Do a test in simulation mode View the pulse height analyzer graph

4 Table of Contents 8.10 Review and approve test results in the queue...46 Section 9 Historical reports View, print and/or export historical test reports Attach an archive database...50 Section 10 License Update...53 Section 11 Procedure Builder Make a report template Start the report template wizard Enter the report titles Enter the report headers Select the format for test parameters and results Preview the report template Name and save the report template Make a user-defined procedure Start the procedure wizard Enter the sample identifiers Enter the computational and parameter settings Enter the pass/fail criteria Enter instructions for the procedure Select a report template Name the procedure Review and save the procedure...59 Section 12 Procedure Distributor...61 Section 13 Procedure Loader...63 Section 14 Troubleshooting Detach and attach the PharmSpec database...69 Section 15 Using the online help...71 Section 16 Using the shortcut keys...73 Index

5 Section 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 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? 1.2 Software components New PharmSpec 3 features include: Compatibility with the HIAC 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 Component License Update PharmSpec Description Used to upgrade the license key for PharmSpec (refer to License Update on page 53) Used to configure the test setup, do tests and show results/reports /activity logs 3

6 PharmSpec 3 description Component Procedure Builder Procedure Distributor Procedure Loader Simulation Application Database Utility Description An optional software component that allows a user to make user-defined procedures and new report templates (refer to Procedure Builder on page 55) Used to save licensed procedures and user-defined procedures to a Microsoft Access database file (refer to Procedure Distributor on page 61) 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) 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) Used to restore, backup and archive data. 4

7 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 Processor Operating System Memory Hard disk FN Drives Display Power supply Removable drive Printer Port Software Requirement Pentium 1.0 GHz Windows XP with Service Pack 3 or later Windows Vista with Service Pack 2 or later Windows 7 platforms 64 bit for all OS 512 MB of RAM 2 GB of available hard-disk space A CD drive, DVD drive, USB port or network connection is required for installation Super VGA video adapter and monitor, 1024 x 768 or higher resolution Uninterruptable power supply (UPS) Removable drive for backing up data, such as a recordable CD or a network server that can back up the computer hard drive Color printer capable of printing at 300 dpi or 9705: USB port to connect sampler, or 9703: COM port to connect sampler 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. 2. Put the installation disk in the CD or DVD drive. 5

8 Installation Figure 1 Select Features screen 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. 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. 6

9 Installation Figure 2 Choose Destination Location screen Figure 3 Select database server 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. 7

10 Installation 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 8 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.

11 Installation 2.3 Windows settings Option Display settings Decimal separator Date separator and format Time separator and format 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 Setting Set for small fonts Set correctly for the user (typically either the decimal. or comma, character) Set the date separator and format for the short date as the user wants it to be shown in PharmSpec Set the time separator and format as the user wants it to be shown in PharmSpec 9

12 Installation 10

13 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. The PharmSpecxxx Properties window opens. 11

14 Administration 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). 12

15 Administration 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. 13

16 Administration 3.4 Remove users 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. 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. 14

17 Administration 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. 15

18 Administration 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. 3.6 Enable a procedure 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. 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. 16

19 Administration 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. 17

20 Administration 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. 18

21 Administration 3.8 Archive data 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. 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. 19

22 Administration 3.9 Restore the database 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. 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. 3. From Windows, select Start, All Programs, PharmSpec, Database Utility. 20

23 Administration 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. Figure 6 SA password screen 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. 8. Enter the password that was entered during the installation procedure. 21

24 Administration 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 View the activity logs Figure 7 Activity logs screen (partial) 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. 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. 8. To close the window, click Close. 22

25 Section 4 Hardware installation 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 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 hardware driver. The default location for the hardware driver is C:\Program Files \PharmSpec\Hardware Drivers\<sampler model>. 23

26 Hardware installation 24

27 Section 5 Hardware settings or sampler 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). 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 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 Add a sensor To add a sensor to the hardware settings (9703 and only): 1. Click Sensor in the Add/Modify/Remove area of the Hardware Settings window. The Add Sensor window opens. 25

28 Hardware settings 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 Files/PharmSpec/validconfig.xml file, PharmSpec will not be able to validate the configuration and bubble detection warnings will not given by PharmSpec. 26

29 Hardware settings 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 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 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. 27

30 Hardware settings 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 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 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. 10. Click Close to close the window. 28

31 Hardware settings 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 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 only). Note: A 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. 29

32 Hardware settings 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) 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 sampler 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. 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 confirm. 30

33 Hardware settings 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. 31

34 Hardware settings 32

35 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 Tare volume Multi-stroke tare Description 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. 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. When selected, the test results of the first run will not be used in the computations but will still be shown and stored. 33

36 Operating parameters 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 Enter a sample identifier label in each field, such as Lot ID and Batch ID. 6. Click OK. 34

37 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. c. Enter the time of day when the update check is done. d. (Weekly) Select the day of the week for the update check. 35

38 Setup options 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. 7.2 Select report options 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. 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. 36

39 Setup options 4. Select the number of blank signature lines for reviewers on printed reports-0 to 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. 37

40 Setup options 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 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 38

41 Section 8 Operation 8.1 Log in 8.2 User interface Figure 8 PharmSpec main window 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. 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. 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. To view the rights of the user currently logged in to PharmSpec, select User, View Profile. To view the rights of all the PharmSpec users on the computer: 39

42 Operation 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 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 Flush Arm Up Versions Abort/Stop Close Help Draws the sample in to the sampler to remove air and to make sure that the sample is in the sensor when counting starts. (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. Raises the sensor arm so that a user can remove or change of the sample. Shows the sampler and counter version. Cancels the current manual sampler operation. Closes the Sampler Control window. 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: 40

43 Operation 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 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 41

44 Operation 8.6 Do a counter test 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. 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 42 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. 6. Do the steps in the Description field. 7. Change the test parameters as necessary.

45 Operation 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 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. 43