This chapter discusses the acquisition of electronic signatures (e-signatures) on electronic records (e-records) in Oracle Bills of Material. E-records and e-signatures enable you to comply with the 21 CFR Part 11 regulations.
This chapter covers the following topics:
The Food and Drug Administration (FDA) protects the public health by regulating the food and drug industries. In 1997, the FDA issued new regulations for quality systems using computerized software in the FDA Code of Federal Regulations (CFR) Title 21 Part 11, otherwise known as 21 CFR Part 11. The regulations strive to assure that computerized records are safe, secure, and as accurate as a paper based system.
According to 21 CFR Part 11, the software application's role in the data management process is to guarantee and substantiate that the manufactured product data is electronically captured, manipulated, extracted, and coded during the manufacturing of the product. All subject data and definitional objects (metadata) must have a complete audit trail.
In general, 21 CFR Part 11 describes the requirements that must be met when using electronic records (e-records) and electronic signatures (e-signatures), but does not describe where they are required. The FDA left the definition of where to use electronic records and which signatures to apply as electronic signatures to the discretion of the medical device manufacturers who use software applications as part of their quality management system. The predicate rule used by the medical device manufacturers is FDA 21 CFR Part 820. Oracle Discrete Manufacturing Applications enable electronic records and signatures for certain business events, as well as give users ways to choose which business events must meet 21 CFR Part 11 requirements, by using the Oracle E-Records product. Refer to the Oracle Manufacturing Implementing Oracle E-Records in Discrete Manufacturing Guide and the Oracle E-Records Implementation Guide for information on how to tailor Oracle E-Records to meet your needs.
Depending on the type of business event, an electronic signature is either online or deferred. An online signature requires that you enter a valid signature before saving the event or transaction. A deferred signature enables you to save the event in a Pending Approval state before obtaining a final signature. Many times a deferred signature requires a workflow approval, so the event is saved before full approval is received back from the workflow process.
Certain business events also include any attachment made to the business event object in the e-record. For example, if a drawing depicting an engineering change is attached to an engineering change order, you can review the drawing in the e-record for the engineering change order.
The e-records and e-signatures (ERES) framework is a central tool designed to achieve 21 CFR Part 11 compliance for the necessary Oracle Applications business events. The ERES framework uses common Oracle Applications components such as Oracle Workflow business events, the XML Gateway, and others.
In order to enable electronic records and signatures for Oracle Bills of Material, you must follow the steps listed in Implementing E-Records, Oracle E-Records Implementation Guide. Otherwise, no e-records or e-signatures are required.
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E-records and E-signatures for Oracle Bills of Material
Viewing Oracle E-Records and E-Signatures, Oracle Quality User's Guide
The following table lists the Oracle Bills of Material events seeded in Oracle E-Records.
| Event | Online or Deferred E-signature | E-Record Includes Attachment |
|---|---|---|
| Bill Creation | Online | Yes |
| Bill Update | Online | Yes |
| Routing Creation | Online | Yes |
| Routing Update | Online | Yes |
| Mass Change Bills | Online | No |
The Bills of Material window starts the signature capturing process whenever a bill is created or updated. While the event is happening in the window, required signatures can be captured online. See: Creating a Bill of Material, Oracle Bills of Material User's Guide. No e-signature is requested when bills are created or updated by an ECO implementation or when engineering bills are transferred or copied to manufacturing. Instead, the ECO Approval, Transfer to Manufacturing, or Copy to Manufacturing events capture the e-signature. See: E-records and E-signatures for Oracle Engineering, Oracle Engineering User's Guide. Select eRecord Details from the Bills menu to view the e-record associated with the bill of material.
The Routings window starts the signature capturing process whenever a routing is created or updated. While the event is happening in the window, required signatures can be captured online. See: Creating a Routing, Oracle Bills of Material User's Guide. No e-signature is requested when routings are created or updated by an ECO implementation or when engineering routings are transferred or copied to manufacturing. Instead, the ECO Approval, Transfer to Manufacturing, or Copy to Manufacturing events capture the e-signature. See: E-records and E-signatures for Oracle Engineering, Oracle Engineering User's Guide. Select eRecord Details from the Actions menu to view the e-record associated with the routing.
The Mass Change Bills window starts the online signature capturing process in different ways, depending on how you access the window:
If you access the window by navigating to Bills of Materials > Bills > Mass Changes, the online signature capturing process begins once you select the Implement box and choose Submit.
If you access the window by navigating to Engineering > ECOs > Mass Changes, the online signature capturing process begins once you select the Create ECO box and choose Submit.
See: Mass Changing Bills of Material, Oracle Bills of Material User's Guide and Mass Changing ECOs, Oracle Engineering User's Guide. Select eRecord Details from the Tools menu to view the e-record associated with the changed bills.
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Viewing Oracle E-Records and E-Signatures
You can view e-records and e-signatures using the following methods:
Using the Oracle E-Records Evidence Store to query e-records and e-signatures. See: Evidence Store, Oracle E-Records Implementation Guide.
Selecting the eRecord Details option from the Tools menu of a transaction or event initiating form. This option is available from many, but not all, of the transaction or event initiating forms.
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