21/21 
Index
A
accelerated stability testing 
link
acceptable values 
link
Acceptance sampling 
link
account 
link
action codes 
link
action codes 
link
action codes setup 
link
Active specifications 
link
actual test quantity 
link
Add Tests window 
link
ADJI 
link
Aggregate Samples
  enter an aggregate sample 
link
Aggregate Specifications
  enter an aggregate sample 
link
  enter an aggregate specification 
link
  enter an aggregate specification validity rule 
link
Aliquots, in sampling 
link
application setup 
link
Approval Matrix 
link
Archive samples 
link
arithmetic operators, in Expression test 
link link
audit trail, in version control 
link
available inventory, in Oracle Order Management 
link
B
base specification 
link link
Batch creation, sampling in 
link
batch step completion and quality test results 
link
batch step release 
link
batch step release, and quality sampling 
link
batch step, preventing completion of 
link
Batch termination 
link
batch update, using sample quantity 
link
C
certificate formatting 
link
Certificate of Analysis 
link link link link
Certificate of Analysis Report window 
link
Certificate of Conformance 
link link
certification
  certificate of analysis 
link
  certificate of conformanceCertificate of AnalysisCertificate of Analysis or Certificate of Conformance 
link
certification of tests 
link
cGMP 
link
classes, in test data type 
link
code, status 
link
collaborative analysis, in test grouping 
link
Components, navigation 
link
Composite Results window 
link link
Conditions, specifying in search and replace 
link
conditions, specifying in search and replace 
link
conformance to specification 
link
Consider Optional Tests Results 
link link
consider optional tests results 
link
Consider Optional Tests Results 
link
control batch step status 
link
control batch step status, use of WIP specification validity rule 
link
Control lot attributes 
link
control lot attributes 
link
Control Lot Attributes indicator 
link
convert test units 
link
converting UOMs 
link
copy a specification 
link
copy specification 
link
count, in sampling plan 
link
Create Samples Automatically 
link
Customer Display dialog box 
link
Customer Test Results report 
link
Customer Validity Rules node 
link
D
data types, in tests 
link
delayed lot entry 
link
Delayed Lot Entry indicator 
link
Detail views 
link
Display, hierarchical 
link
document types 
link
E
editing results 
link
electronic results 
link
electronic signatures 
link
environmental conditions 
link
environmental monitoring 
link
environmental variables, in stability testing 
link
Exact Spec Match 
link
exact specification match 
link
experimental error 
link
  region 
link link
  rules 
link
Experimental Errors window 
link
Expiration date 
link
expiration date 
link
expiration dating 
link
expired lots, managing 
link
Expression test 
link
  example of entering 
link
  test unit conversion 
link
Expression test type 
link
expressions, evaluating partial 
link
expressions, in quality testing 
link
F
failures, in process behavior 
link
FDA 
link
find a sample storage summary 
link
Find Sample Storage Summary window 
link
Find Samples dialog box 
link link link
Find Samples window 
link
Find Sampling Plans dialog box 
link
Find Specifications dialog box 
link
Find Specifications window 
link
Find Stability Studies dialog box 
link
Find Status Codes dialog box 
link
Find Storage Condition Plans dialog box 
link
Find Test Classes dialog box 
link
Find Test Interval Plans dialog box 
link
Find Test Methods dialog box 
link
Find Test Units dialog box 
link
Find Tests dialog box 
link
Find Variants dialog box 
link
fixed number sampling 
link
frequency of sampling 
link
frequency type, in sampling plan 
link
G
Generate Test Intervals dialog box 
link
generic resources 
link
Glossary 
link
GMD
  Include Optional Tests in Sample Disposition 
link
Good Manufacturing Practice 
link
grade 
link
grade, updating 
link
grades 
link
grades setup 
link
GRDI 
link
Group Enabled indicator 
link
grouping tests 
link
H
Hierarchical display 
link
Hierarchy, of navigator 
link
I
In-Spec status 
link
inquiries 
link
inspection points 
link
inspection, receiving 
link
instrument scheduling 
link
instruments, used in quality testing 
link
inventory adjustment 
link
Inventory organization 
link
Inventory Validity Rules node 
link
Item 
link
item attributes 
link
item revision 
link
Item Samples window 
link link
Item samples, system-generated 
link
Item Specifications 
link
Item substitution 
link
item substitution 
link
item units of measure 
link
Item/Location Required Analysis report 
link
items 
link
L
laboratory 
link
Leaf node 
link
List of Test Values test 
link
locator 
link
locator, in monitoring specification 
link
lot attributes 
link
Lot expiration date 
link
lot expiration, management of 
link
Lot Optional 
link
Lot Retest/Expiry indicator 
link
lot-specific unit of measure conversion 
link
M
managing results 
link
Manual Allocate 
link
Manual Spec Selection 
link
Mass Results Entry Test Selection window 
link
Mass Results Entry window 
link
Mass search and replace
  Specifications 
link
  Validity rules 
link
material attribute 
link
material source organization 
link
Material Sources window 
link
material status, updating 
link
mathematical expressions, in quality testing 
link
mathematical functions, in Expression test 
link
Mode statistic 
link
Monitoring Samples window 
link
monitoring specification 
link link
Monitoring Specifications 
link
N
Navigation components 
link
Navigator 
link
Nodes 
link
Non-Validated test 
link
nonconforming material 
link
Notification window, in workflow 
link
Numeric Range test 
link
Numeric Range with Display Text test 
link
O
open-ended ranges, in numeric range tests 
link
Operating unit 
link link
OPM Quality Management 
link
OPM Quality Sample Creation workflow 
link
OPM Quality Spec Customer Validity Rule Status Change approval workflow 
link
OPM Quality Spec Inventory Validity Rule Status Change approval workflow 
link
OPM Quality Spec Monitoring Validity Rule Status Change approval workflow 
link
OPM Quality Spec Supplier Validity Rule Status Change approval workflow 
link
OPM Quality Spec Validity Rule Status Change Approval workflow 
link
OPM Quality Spec WIP Validity Rule Status Change approval workflow 
link
OPM Quality Stability Study Change Status workflow 
link
OPM Quality Stability Study Lot Sample workflow 
link
OPM Quality UOM Conversion workflow 
link
Oracle Approval Management Engine (AME) 
link
Oracle E-Records 
link
Oracle Inventory application 
link
Oracle Inventory, related to quality 
link
Oracle Order Management 
link
Oracle Order Management, in specification matching 
link
Oracle Purchasing 
link link
Oracle Quality 
link link
Oracle Receivables 
link
Oracle Workflow 
link
Oracle Workflow Business Event Systems 
link
organization 
link
organization type 
link
Organization, quality laboratory 
link
Other applications setup 
link
Out-of-spec status 
link
overlay specification 
link link
owner organization 
link
P
Parent lot 
link link link
parent lot 
link link
period, in sampling plan 
link
Personal folder 
link
PL/SQL NVL function 
link
planned test quantity 
link
plant 
link
potency 
link
precision, in reports 
link
preventing batch step completion 
link
Print Additional Test on COA, option 
link
Process Execution application 
link
Process Execution, related to quality 
link
process flow, in quality management 
link
process loss 
link
Process Quality Parameters window 
link link link link
Process Quality Parameters window 
link
Product Development application 
link
Public folder 
link
Q
quality attributes for items setup 
link
quality certificate 
link
Quality Change Disposition dialog box 
link
Quality Change Disposition window 
link
quality grade 
link
quality improvement 
link
Quality inspection 
link
Quality laboratory 
link
quality laboratory 
link
Quality laboratory organization 
link
Quality Management Responsibilities 
link
Quality Manager 
link
quality requirements 
link
Quality sample disposition workflow 
link
quality sampling 
link
quality specifications status change approval workflow 
link
Quality Technician 
link
quality test units 
link
Quality test workflow 
link
quality testing 
link
Quality tests setup 
link
Quality UOM Conversion Notification 
link
Quality Workbench 
link
quantity-based sampling 
link
R
reason code 
link
reason code 
link
reason code access setup 
link
receiving inspection 
link
receiving inspection result 
link
referential integrity 
link
report precision 
link
reports 
link
  Certificate of Analysis 
link
  Certificate of Conformance 
link
  Customer/Vendor Test Results 
link
  Item/Location Test Results 
link
  Production Test Results 
link
  Sample Label Generation 
link
resample action 
link
Reserve sample 
link
resource, in monitoring specification 
link
responsibilities 
link
Result Association window 
link
result statistics 
link
Results window 
link link link
results, managing 
link
Retained sample 
link link
retest action 
link
retest date 
link
retest interval 
link
retest process 
link
Revision 
link link link
revision 
link
S
Sample
  collection 
link
  inspection 
link
  supplier 
link
sample approval management engine 
link
Sample Creation Notification 
link
Sample Creation Notification Workflow 
link link
Sample disposition 
link link link
Sample Disposition Notification 
link
Sample expiration date 
link
Sample group disposition 
link
Sample Group Disposition Notification 
link
Sample group disposition workflow 
link
Sample Group Rejection Notification 
link
sample group rejection workflow 
link
Sample Groups window 
link link
Sample Label Generation report 
link
Sample Storage Summary window 
link
Samples By... windows 
link
Samples Summary window 
link link
Samples tab 
link
Samples window 
link
Samples, impact of batch termination 
link
sampling
  fixed number 
link
  quantity-based 
link
sampling frequency 
link
Sampling methodologies 
link
sampling plan 
link
Sampling Plan window 
link
sampling plan, definition 
link
sampling process 
link
scheduling tests 
link
security profile access setup 
link
Select Available Inventory window 
link
sequencing tests 
link
set up material status 
link
Setting Up Quality Responsibilities 
link
setup, in other applications 
link
shelf life, in stability testing 
link link
Show Active Samples indicator 
link
Show Active Specs indicator 
link
Spec Customer Validity Rule Status Change Approval Notification 
link
Spec Inventory Validity Rule Status Change Approval Notification 
link
Spec Monitoring Validity Rule Status Change Approval Workflow 
link
Spec Status Change Approval Notification 
link
Spec Supplier Validity Rule Status Change Approval Notification 
link
Spec WIP Validity Rule Status Change Approval Notification 
link
Specification
  updating inventory quantity 
link
specification 
link
  stability studies 
link
Specification Comparison window 
link
specification limits 
link link
specification matching 
link link
specification matching procedure 
link
specification matching setup 
link
specification maximum 
link
specification minimum 
link
Specification Summary window 
link
Specification validity rule status 
link
Specification validity rules 
link
specification validity rules 
link link link link link
Specification Validity Rules window 
link
Specifications tab 
link
Specifications window 
link link
stability studies 
link link
  accelerated testing 
link
  additional testing 
link
  attachment usage 
link
  completion 
link
  concluding the study 
link
  container closure systems 
link
  expiration dating 
link
  FDA 
link
  guidelines from FDA 
link
  ICH conditions 
link
  initial sampling material 
link
  inventory organization 
link
  item 
link
  item revision 
link
  launch 
link
  lifecycle 
link
  master item specification 
link
  monitoring specification 
link
  owner 
link
  packaging 
link
  pull samples for testing 
link
  relative humidity 
link
  results, communication of 
link
  sample protocols 
link
  sample size 
link
  scheduled dates 
link
  setup 
link
  storage condition plan 
link link
  storage condition recommendation 
link
  storage conditions 
link
  storage package 
link
  temperature 
link
  test accuracy 
link
  test interval plan 
link
  test linearity 
link
  test methods 
link
  test reliability 
link
  test sensitivity 
link
  test specificity 
link
  testing grace period 
link
  testing program 
link
  testing time points 
link
  workflow 
link
Stability Study Batch Creation Notification 
link
stability study batch creation workflow 
link
Stability Study Change Status Notification 
link
Stability Study Late Time Point Scheduling Notification 
link
Stability Study Lot Sample Notification 
link
Stability study sample records 
link
stability study status change workflow 
link
Stability Study Testing 
link
stability study testing workflow 
link
Stability Study Time Point Scheduling Notification 
link
stability study time point test workflow 
link
Stability Study window 
link link
status 
link
Status Approval Workflow 
link
  disabling 
link link
  understanding 
link
status codes 
link
Status Codes window 
link
status codes, in status control 
link
Status Details window 
link
storage condition 
link
storage condition parameters 
link
storage condition plan 
link link
Storage Condition Plans window 
link
storage conditions 
link
storage organization 
link
Storage Packages window 
link
storage requirements, in stability studies 
link
STSI 
link
subinventory 
link
Subscriptions 
link
Summary views 
link
Supplier samples 
link
Supply chain, sampling 
link
system security profile 
link
T
targetexperimental errorregionexperimental error region. 
link
Terminated batch, impact on samples taken 
link
Terminated batches 
link
Terminating batches 
link
test
  dependencies 
link
test class
  creating test groups 
link
Test Classes window 
link
test data type 
link
test definition 
link
Test Details window 
link
test interval plan 
link link
Test Interval Plan window 
link link
test method
  adding edit text 
link
  duplication 
link
  purging 
link
test method, attributes of 
link
Test Methods window 
link
test range 
link link
test result, interpreting 
link
test unit 
link link
Test Units window 
link link
test units, converting 
link
test units, quality 
link
test, certification 
link
test-specific attributes 
link
testing instruments 
link
Testing Notification 
link
Testing Time Point Label Generation report 
link
testing time points 
link
testing, quality 
link
testing, stability 
link
tests
  Expression 
link
  List of Test Values 
link
  Non-Validated 
link
  Numeric Range 
link
  Numeric Range with Display Text 
link
  scheduling 
link
  Text Range 
link
Tests node 
link
Tests window 
link link
Text Range test 
link
Time Based Sampling 
link
  process 
link
time points 
link
tolerance, in experimental error 
link
Tool palette 
link
Transact Move Orders 
link
U
U.S. Food & Drug Administration 
link
Understanding License Plate Numbers for Containerization 
link
unit of measure conversions 
link
Unit Specification
  enter an aggregate specification validity rule 
link
Unit Specifications 
link
  enter a unit specification 
link
  enter an aggregate sample 
link
  enter an aggregate specification 
link
  enter unit specification validity rules 
link
UOM conversion 
link
UOM conversion workflow 
link
update inventory quantity 
link link
V
validity rule 
link
Validity rules 
link
Validity Rules for Item Spec window 
link
Validity Rules for Item Specifications window 
link link
Validity Rules for Monitoring Spec window 
link
Validity Rules Summary for Item Spec window 
link
Validity Rules Summary for Monitoring Spec window 
link
validity rules, specification 
link link
Variant Time Points window 
link
Variant window 
link
variants 
link
Version Control 
link
  Specification Version Control 
link
version control 
link
version control, specifications 
link
View By functionality 
link
View Samples For Test window 
link
W
wildcard, use in search and replace 
link link
WIP specification validity rule, use of 
link
WIP Validity Rules 
link
workflow
  Status Approval 
link
Workflow Automatic Notification Processing 
link
Workflow Notification Subsystem 
link
X
XML Gateway 
link