User Information Plan Template
Document Information:
Filename
Current Owner
Product Identifier
Project Identifier
Current Lifecycle Phase
Revision Log:
Version
Date
A.00
May 27,
2003
Form Rev. Feb 05, 2002
USERINFO.DOC
Deborah Perkins
H2297A (Cerity A.01)
SS030154
Release
Reason For Update
Initial user information plan.
Product Availability Date: May 27, 2003
Localization Plans: Japanese
Product Release Bulletin Available(location): EPI Warehouse
Course Description:
This two-day lecture and laboratory course is designed for those Cerity Pharmaceutical
QA-QC operators who will have full access to the software including method
development tasks. The topics covered include advanced topics in reprocessing, building
custom queries, integration, peak identification, quantitation, custom sample variables,
custom calculations, system suitability, report templates, sequences, instrument details,
and Agilent 1100 software specifics. H2296A is a prerequisite for this course.
Course Deliverables:
Powerpoint slides for instructor presentation
Word modules for each presentation
Word manuals, student and laboratory manual
Pdf of student manual and laboratory manual
Pdf of instructor manual with userinformation plan. There are not many
instructors notes. All known information is either provided in the student
notes or in the “Preparations” section of the laboratories.
1. Course Outline with correlation to filenames:
1. Result Review
01_resultsreview.ppt/.doc
2. Laboratory Exercise: Results Review
01_labresultreview.doc
3. Queries
02_querywizard.ppt/.doc
4. Laboratory Exercise: Query Wizard
02_labquerywizard.doc
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5. Integration
03_integration.ppt/.doc
6. Laboratory Exercise: Integration
03_labintegration.doc
7. Compound Identification
04_peakident.ppt/.doc
8. Advanced Quantitation
05_advquant.ppt/.doc
9. Laboratory Exercise: Compound Identification,
Calibration, and Quantitation
05_labquant.doc
10. Sample Variables
06_samplevariable.ppt/.doc
11.Custom Calculations
07_customcalc.ppt/.doc
12. Laboratory Exercise: Custom Calculations
07_labcustomcalc.doc
13. System Suitability and Limits
08_suitability.ppt/.doc
14.Report Template Editor
09_reporttemp.ppt/.doc
15.Laboratory Exercise: Report Template Editor
09_labreporttemplate.doc
16.Advanced Sequencing
10_advsequence.ppt/.doc
17.Instrument Details
11_instrumentdetail.ppt
/.doc
18.Agilent 1100 HPLC
4.
12_agilent1100.ppt/.doc
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:
developing Cerity methods, sample entry, sequence entry, running
samples and sequences, result review and reprocessing, integration,
acquisition method parameters, and accept/reject. In addition, the
instructor must be able to create custom calculations, custom variables,
custom queries, and report templates.
c. The instructor must be able to set up and maintain and Agilent 1100 Series
HPLC. The instructor must also know common maintenance and tests for
the Agilent 1100 Series HPLC such as detector intensity test, pump ripple,
etc.
5.
Instructor 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
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cannot duplicate usernames and passwords. Also, problems may occur with
customers trying to access the same methods at the same time. 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 III, 40 GB, 512 MB memory, display 1024 x 768.
Agilent 1100’s are not required for this course. The data systems with restored data
are the only required instrumentation.
1) Follow the instructions in the Cerity Installation manual to install a professional
systems.
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) 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
4) 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, and database name before the
first laboratory exercise. There is a place in the laboratory exercise for them to
write down the information.
5)
6) Add printers. The report template laboratory requires the use of printers.
7) Restore the data for this course. The data is found in the EPI warehouse.
Search for the course, H2297A. Download the zipped file, archive2297a.zip.
Restore the sequences first, then the samples.
5.

6.
Consumables Required for Delivery :
None
Electronic files required for product delivery:
Restore the data provided using the archive and restore utility. You need only
restore sequences and samples. The methods will restore with the sequences.
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7.
Tools required for product delivery:
No tools are required.
8.
Laboratory Preparation Instructions:
Restore sequences and samples
9.
Activities required during product delivery:
Cerity software is complicated. Check on students to make certain they are not
having problems during the lab exercise.
10.
Activities required after product delivery:
Please forward any comments to Deborah_perkins@agilent.com.
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