21 CFR Part 11 Compliance

This appendix covers the following topics:

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 Field Service 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.

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.

To enable electronic records and signatures for Oracle Field Service Applications, follow the steps listed in Implementing E-Records, in the Oracle E-Records Implementation Guide. Otherwise, no e-records or e-signatures are required.