User Information Plan TemplateForm Rev. Feb 05, 2002

Document Information:

Filename / USERINFO.DOC
Current Owner / Deborah Perkins
Product Identifier / H2295A (Cerity A.01)
Project Identifier / SS000086
Current Lifecycle Phase / Release

Revision Log:

Version / Date / Reason For Update
A.00 / 02/06/24 / Initial user information plan.

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Product Availability Date: June 14, 2002

Localization Plans: No current plans

Product Release Bulletin Available(location): EPI Warehouse

1)Course Description:
This one-day lecture and computer laboratory course is designed to give essential operation training to routine users of Cerity NDS Pharma QA-QC software. Topics include running samples and sequences, reviewing and reprocessing data, queries, and instrument details for the Agilent 1100. The appendix contains information on GC and Waters instruments as well as a lab for Agilent 1100 HPLC’s.

2)Course Deliverables:

Powerpoint slides for instructor presentation

Word modules for each presentation

Word manual

Pdf of student manual

Pdf of instructor manual with userinformation plan

Restorable methods for laboratories

Virtual device for laboratory along with electronic data, sequencechannela and channeladata.

3)Course Outline with correlation to filenames:

1. Cerity NDS Pharmaceuitcal QA-QC Overview01_cerityoverview.ppt/.doc

2. Running Samples02_entryrun.ppt/.doc

Note: If you have Agilent 1100’s available, then you may perform the lab found in the appendix now. It is optional based upon the availability of instrumentation. The lab file is 02_labagilent1100.doc.

3. Running a Sequence03_runsequence.ppt/.doc

4. Laboratory Exercise: Run Samples and Sequences03_labrunsequence.doc

5. Result Review04_reviewreport.ppt/.doc

6. Laboratory Exercise: Integration04_labintegration.doc

7. Laboratory Exercise: Result Review04_labresultreview.doc

8. Changing Method Parameters05_method.ppt/.doc

9. Queries06_querywizard.ppt/.doc

10.Laboratory Exercise: Queries06_labquerywizard.doc

11.Instrument Details07_Instrumentdetails.ppt/

.doc

Appendix

GC08_gcappendix.ppt/.doc

Laboratory Exercise: Agilent 6890 GC08_lab6890.doc

Waters 2690 and 248709_wastersappendix.ppt

.doc

Laboratory Exercise: Agilent 1100, running samples 02_labagilent1100.doc

4)Instructor or Delivery Agent skills and training required prior to product delivery:

a)The instructor must be able to set up a Cerity NDS Pharam QA-QC professional system.

b)The instructor must have command of the following Cerity features: sample entry, sequence entry, running samples and sequences, result review and reprocessing, integration, acquisition method parameters, query development, and Agilent 1100 features and tests.

c)The instructor must have command of the Agilent 6890 operation and features using Cerity NDS for Pharma QA-QC if required during course.

d)The instructor must have some knowledge to answer basic Waters operation with the Cerity NDS for Pharma QA-QC if required during the course.

5)Course Set-up

To avoid extra work, install a series of professional systems, two students per system. Use the Installation Manual found on the EPI warehouse for Cerity NDS for Pharmaceutical QA-QC to install the professional systems. You can make one image of a professional system and copy to each required computer in the classroom. It is much more difficult to set up in a client/server environment as you cannot duplicate usernames and passwords. Also, there will be problems accessing the same virtual detector, etc. at the same time, requiring you to make many modifications in order to get the course to run without problems. The subjects the students are learning in this course are not compromised by the use of professional systems. The minimum hardware for a professional system is:

Pentium II, 350 MHz, 256 MB memory, display 1024 x 768.

1)Follow the instructions in the Cerity Installation manual to install a professional systems. Install BootP as well.

2)Create an NT and Cerity user that has administration rights for the students to use. If you have professional systems, you can use the same name and password for each student pair.

3)There are several optional lectures and laboratories in the Appendix. You must decide in advance if you will need to include any of the following:

Will I make Agilent 1100’s available to my students? If you will have Agilent 1100’s, then you can add the laboratory in the appendix: Build a Single Sample Method and Make a Single Sample Injection. The goal of this laboratory is to allow the student to interact with the Agilent 1100 graphical interface and learn how to set up the instrument for runs. They will be able to interact with the instrument parameters and actuals.

Will I have to teach my customers about the Agilent 6890? If the answer is yes, then there are both lectures and laboratories available in the appendix. Adding this material will of course, require more course delivery time.

Will I have to teach my customers about the Waters systems? Teaching the Water’s material will probably be difficult without any Water’s training. There are slides, however, showing the Water’s UI’s in the appendix.

4)In the Cerity Software administration add the database on each professional system. Add the following licenses:

PharmaQC Client

Certificate Id = 227718958

License Code 1=15883188

License Code 2=1112809637

Cerity GMP Module

Certificate Id = 253930026

License Code 1= 15630315

License Code 2 = 1381245605

1100

Certificate Id =279095810

License Code 1=15570150

License Code 2=1113858599

35900

Ceritficate Id =262321183

License Code 1=16048011

License Code 2=1111765671

5)Create users for the students and give them all rights (administrator). Explain that they may not have all rights in their laboratory. You will need to provide the students with their usernames, passwords, database, and instrument name, if applicable, before the first laboratory exercise. There is a place in the laboratory exercise for them to write down the information. An instrument is only necessary if you will perform the optional Agilent 1100 laboratory in the appendix. Install the Agilent 1100’s if necessary.

6)Install the virtual device. Exception: Do not install this on a customer system. Never give the vdt to a customer.

VDT Instructions for installation on professional system

  1. Download the vdt folder from the EPI warehouse. Move it to the Cerity hard drive and unzip the file.
  2. Go to the command prompt and type: ipconfig /all
  3. Find the physical address. This is the MAC address that you will need to install the vdt. Write this down. Also, record the computer’s IP address.
  4. From the start menu, select Run. Type in: editbootpsettings
  5. In the Bootp settings panel select Launch Manager.
  6. Press the Add… button.
  7. Type in the previously recorded MAC address. Type in the host name (computer name). Type in the previously recorded IP address. OK the panel then Exit Manager. OK the Bootp Settings panel.
  8. Open the Hosts file in notepad. The Hosts file is found at C:\winnt\system32\drivers\etc\hosts. Type in the IP address space and the name, vdt. Save and Close the file.
  9. Open Cerity Software Administration.
  10. Expand the Instruments and locate the acquisition processor (host computer on professional). Right-click and Add Instrument.
  11. Type in the Instrument Name, vdt. The Technique is Liquid Chromatography. Click Next>.
  12. Select Device Type: 35900E Analog to Digital Converter. Select the New… button. The Device Name is vdt. Insert a serial number, 123456. Click Next>.
  13. For the Device Host Name, enter the computername. Click Resolve. The IP address should now appear. Click Next>.
  14. This device runs in Single-channel mode, Channel A. Click Finish and then Finish again.
  15. Save this instrument to the database.
  16. Click and drag on the vdt in the vdt folder to create a shortcut for the students.
  17. Make certain that the virtual device is working by running a test.
  18. Open Cerity Pharma QA-QC software.
  19. Double click on the vdt shortcut to open. Wait until some text appears in the bottom half whitespace then select Enable Sequence. Leave the vdt open.
  20. Restore the vdt methods.
  21. Run a single sample using the VDTsinglesample method.

7)Add printers as desired. Labs do not require printers as they can look at the .htm report instead. Printers are a “nice” addition.

8)Restore the required sequences and samples. You can download the material from the EPI warehouse using the course number H2295A. All the files are contained in the zipped file, data.zip. The required methods will restore with the sequences.

Suggestions for On-site courses: If you are on site, then you will have to adapt to the course based upon their client/server system. Do not install the vdt on a customer system. We suggest that you use the lab in the appendix, Build a Single Sample Method and Make a Single Sample Injection, in an on-site situation. You may then want to add one of their own methods as a sequence. Then, exclude the vdt lab.

9)Consumables Required for Delivery :

If you will be using an Agilent 1100 for the first laboratory then you will need the following:

  • A sample vial labeled testmix that contains the IsocraticTest Mix, Part # 01080-68704, diluted 1:10.
  • A 4.6 x 100 mm, C18 column, 5 m column part number 7982628-554 or similar. If you are using a longer C18 column, the run time will need to be lengthened.
  • HPLC grade water in channel A and HPLC grade acetonitrile in channel B. You may also use methanol in channel B, but may have to adjust some pump parameters.
  • For the GC laboratories use a split/splitless inlet with FID detector. The FID detector check out sample is required along with an HP-5 column.

No other consumables are required.

10)Electronic files required for product delivery:

Download the data.zip. Restore the sequences and samples. All are required for the course.

11)Tools required for product delivery:

If you are using Agilent 1100’s you may need tools to install columns or repair the instrument.

12)Activities required during product delivery:

Cerity software is complicated. Check on students to make certain they are not having problems during the lab exercise. Expect problems. Go to each student group while they are working to make certain they are on track.

13)Activities required after product delivery:

Please forward any comments to .

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