21 CFR Part 11 Compliance

21 CFR Part 11 Overview

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 Engineering 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.

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 Engineering, you must follow the steps listed in Implementing E-Records, Oracle E-Records Implementation Guide. Otherwise, no e-records or e-signatures are required.

Related Topics

E-Records and E-Signatures for Oracle Engineering

See Viewing Oracle E-Records and E-Signatures

E-records and E-signatures for Oracle Engineering

The following table lists the Oracle Engineering events seeded in Oracle E-Records.

Event Online or Deferred E-signature E-Record Includes Attachment
ECO Creation Online* Yes
ECO Update Online* Yes
ECO Approval Deferred Yes
ECO Implementation Online* No
ECO Schedule Online* No
ECO Reschedule Online* No
ECO Cancellation Online* No
Transfer to Manufacturing Online No
Copy to Manufacturing Online No

* 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.

ECO Creation or Update

The Engineering Change Orders window starts the record capturing process whenever an ECO is created or changed.

ECO Approval

When a completed ECO is submitted for approval, the required e-signatures must be captured to complete the approval process. You can enter your signature online, while the event is happening in the window or in deferred mode. All users in the ECO approval list receive workflow notifications requesting that they provide their e-signature before the ECO is approved.

The ECO Approval process requires an additional setup step in Oracle Engineering because this process is not defined in Oracle Approvals Management. You must associate the Change Type and Priority used by the ECO with the ERES Approval Process in Oracle Workflow. See: Defining ECO Types.

When creating the ECO, you must enter a Change Type and Priority that is associated with the ERES Approval Process. You must also select a valid approval list in the Approval List field.

ECO Implementation

You can create an e-record upon either manual or automatic implementation of an ECO. When you implement an ECO, a concurrent program executes your command, captures an e-record, and invokes the necessary event to make the change. The necessary event could be a bill, routing, or item update or a transfer or copy to manufacturing. See: Implementing ECOs..

ECO Schedule, Reschedule, or Cancellation

The action of scheduling, rescheduling or cancelling an ECO creates an e-record. When you select Schedule, Reschedule, or Cancel from the menu, you must enter the date and time, then confirm the action. Once you confirm the action, the e-record is created. See: Implementing ECOs, , Rescheduling an ECO or Revised Item, Oracle Engineering User's Guide, or Cancelling ECOs and Revised Items, Oracle Engineering User's Guide for more information.

Transfer or Copy to Manufacturing

When you transfer or copy items, bills, and routings to manufacturing from within the Engineering Change Orders window using the ERES Approval Process in Oracle Workflow, you eventually schedule an ECO implementation. The e-record is created as described for an ECO implementation and the e-signature is collected as described for an ECO Approval previously in this section. This is the recommended method for transferring or copying data to manufacturing and Oracle suggests removing the other menu entries for manually transferring or copying engineering data to manufacturing.

If you need the flexibility to manually transfer or copy data to manufacturing, the other navigator paths for manually transferring engineering data are provided below. The paths for manually copying engineering data are the same; substitute the word Copy in place of Transfer.

These paths open the Transfer to Manufacturing or the Copy to Manufacturing window. These windows create an e-record and require an online e-signature for every record line once the event is saved.

Related Topics

Viewing Oracle E-Records and E-Signatures

Also see: 21 CFR Part 11 Overview in the Oracle Engineering User's Guide.

Viewing Oracle E-Records and E-Signatures

You can view e-records and e-signatures using the following methods:

Related Topics

21 CFR Part 11 Overview

E-Records and E-Signatures for Oracle Engineering