21 CFR Part 11
FDA regulations that set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
Electronic Batch Record (EBR)
Electronic Batch Record (EBR) replaces manual procedures and paper batch records with an electronic procedure management and record-keeping system. This system is complete with electronic signatures and audit trails. An EBR, as defined by the FDA, includes text, graphics, data, audio, pictorial, or other information represented in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. With an EBR, all batch-relevant data are stored in the computer system.
Electronic Record (e-record)
Any combination of text, graphics, data, audio, pictorial, or other information in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.
Electronic Signature (e-signature)
A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding equivalent of the individual's handwritten signature.
Oracle Manufacturing Execution System (MES) for Process Manufacturing.
Gross Weight
The total weight of material, without deduction for tare, tret, or waste, as distinguished from neat, or net weight.
Label Format
A single design of a label that may include fixed data such as field prompts and variable data such as a part number. A label format is associated to a label type; it includes a subset of the available data elements from a particular label type. Multiple label formats can be associated to one label type.
Label Print Business Flow
An identifiable business process that occurs as part of material handling within Oracle Warehouse Management System. Oracle recognizes a predetermined list of business flows that can be set up to include label printing as part of the transaction processing.
Label Type
A broad category of labels that specifies the super-set of available data elements that can be included on a single label. Currently, there are eleven label types, such as Material, Serial, License Plate Number (LPN), LPN Contents, LPN Summary, Location, Shipping, Shipping Contents, and WIP Contents. All label types are available to a WMS user. Most label types are available to an MSCA user. For instance, MSCA has no association to a license plate, so the LPN, LPN Contents, and LPN Summary label types are not applicable and therefore not available in MSCA. Multiple label formats can be defined per label type. For example, the Material label type includes information such as Part Number, Description, Unit of Measure, Quantity, Hazard Code, Lot Number, Lot Expiration Date, Lot Attributes, and so on.
Instructions are used to amplify the manufacturing process flow by providing details on how to execute certain steps. They also assure a documented, repeatable process; provide for ease of assembly; and improve productivity, quality, and consistency.
Net Weight
The weight of actual goods, excluding packing materials; also called actual net weight.
The weight of a container or wrapper deducted from the gross weight to obtain net weight.
Warehouse Management System product in Oracle Applications E-Business Suite.