User defined message displayed to identify the need for and type of quality related action to be taken when a lot expires, or its results are not in conformance with quality requirements. Examples of actions are: quarantine, retest, resample, and hold.
Assay
See Test.
Assay Type
See Test Data Type.
Assay Units
See Test Units.
Business Event
An event that is of interest to customers or business teams. For example, the movement of inventory to a subinventory is a business event.
Certificate of Analysis
Also, COA. Documentation issued to a customer, or for internal records, indicating the quality tests performed and results reported for item lots shipped.
Certificate of Conformance
Also, CoC. Documentation provided by a supplier or manufacturer that indicates the supplies or services meet the specified requirements. In this application, the Certificate of Conformance lets the process manufacturer to certify shipments that meet certain quality specifications where results are not printed in the document.
Charge
One full load that can be accommodated in a single pass through the equipment. In a process manufacturing plant, the capacity of a step may be predetermined by the capacity of the equipment used in that step. For example, a mixing tank that has a maximum capacity of 1000 gallons overflows if more is added. The maximum capacity determines the total number of charges that are required to process the ingredients required for a batch. A batch size of 5000 gallons requires five charges at 1000 gallons each when the maximum capacity of the mixing tank if 1000 gallons.
CoA
See Certificate of Analysis.
CoC
See Certificate of Conformance.
Decimal Precision
The number of decimal places that are displayed for numeric data. This ranges from zero to nine decimal places, and it determines how the application manages the rounding of significant figures. A decimal number that is five or higher rounds up, while decimal numbers below five round down.
Disposition
The status of a sample or sample group with respect to analysis.
Context Organization
The inventory organization that serves as the framework for the data entered or displayed.
E-Records and e-signatures
To satisfy signoff requirements in regulated industries, electronic signatures are obtained before changes to records become accessible throughout the supply chain. Management configures where and when these signatures are collected by using an electronic record framework. If a signature is required, then an e-signature window displays. Application users are restricted from moving on to the next logical step or status until all required e-signatures are entered.
Event Subscription
Typically perform any or all of the following:
Run custom PL/SQL code.
Send the business event to a predefined workflow.
Use Oracle Advanced Queuing for asynchronous messaging.
Refer to the Oracle Workflow Guide for details on subscribing to a workflow event.
Experimental Error
The error observed defines a region of uncertainty around specification limits for a test that usually requires an action. These action zones can be defined for numeric-based tests.
Expiration Date
Date or time window beyond which an item or lot expires and becomes unusable. This is defined as part of the item master and lot master in OPM.
Frequency Period
Defines the basis of frequency for a sampling plan in terms of hours, batches, lots, and kilograms produced. This corresponds to the frequency count.
Frequency Type
Identifies the type of sampling plan frequency as:
Quantity-based
Fixed Number
Percent
Grade
Combinations of quality attributes that are defined for lot-controlled items. Also, the fitness of an item to preset attributes. For example, diamonds have color and clarity grades as measures of their quality.
ICH
In stability studies. International Conference on Harmonisation.
Instrument
A resource that is linked to a test method so that test results can be traced to the equipment used in the analysis.
Inventory Organization
The plant where batches are produced. Also, the organization that holds the inventory at specified locations. Contains subinventories and locators.
Item Revision
A particular version of an item.
Item Sample
See Sample.
Locator
A specific physical area within a subinventory such as a row, aisle, bin, or shelf where the item is stored.
Locator Control
A technique for enforcing the use of locators during a material transaction that is set at the inventory organization, subinventory, or item level.
Lot
A unit used to group quantities of a specific item when subquantities have slightly different characteristics.
Lot Status
Defined in the Oracle Inventory application. Assigned to one or more lots to indicate if the lots are nettable for planning, or usable for sales, production, or shipping.
Monitoring Sample
See Sample.
Oracle Workflow
A complete workflow management system that supports business process definition, automation, and integration. This technology routes information based on user defined business rules. Notification activities deliver messages to you through e-mail or a notification web page that is accessible using any browser.
Parent Lot
A quantity of an item that shares the same specifications or contains one or more receipts from the same vendor. Genealogically, each parent lot can be divided into child lots, previously sublots, which reflect the characteristics selected for the items within the parent lot.
Process Quality Parameters
A default set of organization-specific controls or options that determines how OPM Quality Management functions.
Quality Laboratory
Process-enabled inventory organization where a sample is tested. Represented as a process-enabled lab inventory organization.
Quality Workbench
A navigator with nodes that you can expand to display groups of individual database objects. Lower level nodes, and the objects they contain, are indented to indicate that they belong to these higher level nodes. The terminal node in a branch is called a leaf node. The workbench has a data organizer that groups objects on separate tabs. Each tab has a unique icon and its own hierarchy. The Quality Management application uses tabs to group specifications and samples. When you select an unexpanded, higher level node on the data organizer, a summary view lists the contents of the container.
Result
Outcome of a quality test performed on an item or lot. Results may not be the expected results as defined in the specification. This can be used to determine that an item or lot is unsuitable to be sold or used.
Retest Date
In stability studies. The date after which samples of the drug substance must be examined to ensure that the material is still in compliance with the specification and thus suitable for use in the manufacture of a given drug product.
Retest Period
In stability studies. The period of time during which the drug substance is expected to remain within its specification and, therefore, can be used in the manufacture of a given drug product, provided that the drug substance has been stored under the defined conditions. After this period, a batch of drug substance destined for use in the manufacture of a drug product must be retested for compliance with the specification and then used immediately. A batch of drug substance can be retested multiple times and a different portion of the batch used after each retest, as long as it continues to comply with the specification. For most biotechnological or biological substances known to be labile, it is more appropriate to establish a shelf life than a retest period. The same may be true for certain antibiotics.
RH
Relative humidity.
Sample
Portion of a lot selected to be tested. Results of tests are used to estimate the characteristics of the entire lot. The application distinguishes between an item sample and a monitoring sample. The item sample can be a physical sample with a source from inventory, WIP, a customer, or a supplier. The monitoring sample is typically a virtual sample from an instrument or other measurement device that monitors equipment such as an environmental chamber. For example, temperature and humidity readings can be monitoring samples.
Sample Group
Also, Sampling Event. Comprised of one or more samples that share a common sample source, item, and lot are tied to the same business event such as receiving, inventory transfer, batch, and expired lot.
Sample Quantity
Total amount of material drawn for inspection, and required for all anticipated tests. It is measured in the inventory unit of measure for the item sampled. The sample quantity can include sufficient material for possible retesting.
Sample Source
Identified as the origin of the sample. For example, the material, resource, locator, or stability study.
Sampling Event
See Sample Group.
Sampling Plan
Identifies how much and how often sampling must occur.
Shelf Life
In stability studies. The time period during which a product is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label.
Specification, Item
A clear, complete, and accurate statement of the quality acceptance criteria for a material, and of the procedure to determine if the requirements are met. A quality specification includes a set of tests.In stability studies. Limits of acceptability derived from the profile of the material as used in the preclinical and clinical batches.
Specification, Monitoring
In stability studies. A specification that defines the details of the storage condition for one of the variants of a stability study. These conditions can include, but are not limited to, the temperature, humidity, and pressure of the storage condition.
Specification Validity Rule
Includes specific information on how and when an item or monitoring specification version applies to inventory, process execution, order management, receiving operations, resources, or locators.
Stability Study
Stability Studies analyze a predefined set of tests at prescribed intervals for various parameters. These may include testing of the active ingredient, measurement of known degradation products, dissolution time, appearance, and other physicochemical criteria.Long term, accelerated, and intermediate studies undertaken on batches according to a prescribed stability protocol to establish or confirm the retest period of a drug substance or the shelf life of a drug product.
Storage Condition
In stability studies. A set of environmental conditions to maintain a climate-controlled storage facility. The length of the studies and the storage conditions are required to cover the conditions of the item's storage, shipment, and subsequent use.
Storage Locator
A restricted or non-restricted subinventory locator where samples are stored.
Storage Organization
Process-enabled inventory organization where a sample is stored.
Storage Package
In stability studies. Refers to the containers in which sample material is stored for stability testing. The packages must be the same as, or it must simulate the actual packaging used for storage and distribution of the finished product.
Storage Subinventory
A validated or non-validated subinventory where samples are stored.
Subinventory
A subdivision of an inventory organization that represents either a physical area or a logical grouping of items, such as a storeroom, damaged inventory, or receiving dock.
Test
Previously, Assay. A generic term for the analysis of the physical and chemical properties of a sample. For example, you can perform a test for chloride using commercially available titrimetric or amperometric test methods.
Test Class
A grouping of tests based on a common set of meaningful characteristics.
Test Data Type
Previously, Assay Type. Categorizes the type of data expected for a test. Numeric and text based data types are available in the application.
Test Kit
Material used in preparing or running a test. For example, a reagent used in a chemical test.
Test Method
Identifies how a test is performed. For example, a test method refers to a standard American Society for Testing and Materials, or ASTM protocol for measuring the property of a material.
Test Procedures and Test Criteria
In stability studies. The testing covers those features susceptible to change during storage and likely to influence quality, safety, and efficacy.
Test Quantity
The amount of material required for a particular test method and instrument, expressed in the inventory unit of measure.
Test Replicate
An iteration of a test that is repeated on the same sample.
Test Units
Previously Assay Units. Unit of measure for quality tests. For example, pH. Test units of measure often differ from inventory units of measure.
Testing Frequency
In stability studies. Frequency of testing sufficient to establish the stability characteristics of the item. Testing under long term conditions typically is every three months, over the first year, every six months over the second year and then annually.
Validity Rule
See Specification Validity Rule.
Variant
In stability studies. The storage condition for a time point sample defined by a unique combination of the material source, stability study storage condition, test interval plan, and optional storage package.