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 described in this chapter), 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 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 Applications, you must follow the steps listed in Implementing E-Records, Oracle E-Records Implementation Guide. Otherwise, no e-records or e-signatures are required.
The following table lists the Oracle Purchasing events seeded in Oracle E-Records.
| Event | Online or Deferred E-signature | E-Record Includes Attachment |
|---|---|---|
| ASL Creation | Online* | No |
| ASL Update | Online* | No |
| Receiving Inspection | Online* or Deferred E-signature | Yes |
| Receiving Group Inspection | Online or Deferred E-signature | Yes |
| Receiving Transfer with Quality Data Collection | Online* | Yes |
| Receiving Delivery with Quality Data Collection | Online* | Yes |
* By default, the online e-signatures marked with an asterisk (*) are disabled. To enable e-signatures for these events, change the ESIG_REQUIRED configuration variable default value to Y. See: Setting Up the Configuration Variables, Oracle E-Records Implementation Guide for information on changing the default value so e-signatures are required.
Important: You must implement Oracle Quality and set the profile option QA:PO Inspection to Oracle Quality in order to capture e-records and e-signatures in Oracle Purchasing.
You capture an e-record when you create or update an Approved Supplier List (ASL) in the Approved Supplier List window, the PO Approval workflow, or through Import Price Catalogs.
To capture an e-record when you perform a receiving inspection, you must have Oracle Quality installed. You capture an e-record when you enter receiving inspection results in the Enter Quality Results window. After entering the receiving inspection results, the required e-signatures must be captured. Enter your signature or defer to a later time. An online signature enables you to sign while the event is happening in the window. A deferred signature can be entered anytime, after the transaction is saved. You can view the status of the e-signatures at any time by viewing the eSign Details window.
Important: Use one of the following transactions to perform a receiving inspection:
PO ERES Receiving Inspection for a single line inspection.
PO ERES Receiving Group Inspection for a multiple line inspection. You must set the form parameter ENABLE_GROUP_INSPECT_ERES to Y in the function RCV_RCVTXERT (Receiving Transactions).
Deferred signature for single and multiple line inspection. You must set the form parameter ENABLE_DEFER_ERES to Y in the function RCV_RCVTXERT (Receiving Transactions).
You capture an e-record when you enter a receiving transfer transaction in the Receiving Transactions window, then select the Inspections button to enter quality data in the Enter Quality Results window.
You capture an e-record when you enter a receiving delivery transaction in the Receiving Transactions window, then select the Inspections button to enter quality data in the Enter Quality Results window.
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 initiating or summary window.