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Oracle E-Records Implementation Guide
Release 12.1
Part Number E13700-04
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21 CFR Part 11
This rule represents the combined effort of divisions within the US Food and Drug Administration (FDA), along with members of the pharmaceutical industry, to establish a uniform, enforceable, baseline standard by which the FDA will consider electronic records equivalent to paper records and electronic signatures equivalent to traditional handwritten signatures.
Any document associated with one or more application entities. You can view attachments as you review and maintain an entity. Examples are operation instructions, purchase order notes, item drawings, or an employee photo.
Any object that furnishes information to support another object or action. Examples are a purchase order, an invoice, a word processing file listing, receiving instructions, CAD files citing an item's specifications, or video instructions of an assembly operation.
Electronic Record
Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.
Electronic Signature
A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.
Electronic Records and Electronic Signatures.
An occurrence in an Internet or intranet application or program that is significant to other objects in a system or to external agents.
Event Subscription
A registration indicating that a particular event is significant to a system and specifying the processing to perform when the triggering event occurs. Subscription processing can include calling custom code, sending the event message to a workflow process, or sending the event message to an agent.
Oracle Approval Management Engine (AME)
This component is used to define conditions, rules and, approval hierarchy. We also want to store rule specific attributes such as Electronic recording required or Electronic Signature is required, what type of style sheet need to be applied for this rule, etc. These rules are evaluated runtime based on Transaction ID (this is the primary key for the transaction).
Workflow Business Event System
Workflow Business Event system is used to define an e-signature event and associate a synchronous e-signature subscription to the event.
XML Gateway
XML Gateway is used for mapping definition and generation of XML for an E-Record. Individual product teams define XML maps and DTD for E-Record and E-Signature (ERES) Events supported by them. These Maps and DTD are loaded into the database and source controlled under respective product tops. The E-Record style sheet is also defined as part of XML Gateway.