Manage Regulatory Compliance

This chapter discusses the acquisition of electronic signatures (e-signatures) on electronic records (e-records) in Oracle Quality. E-records and e-signatures enable you to comply with the 21 CFR Part 11 regulations.

This chapter 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 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 Quality, 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 Quality

Viewing Oracle E-Records and E-Signatures

E-records and E-signatures for Oracle Quality

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

Event Online or Deferred E-signature E-Record Includes Attachment
Collection Element Creation Online* No
Collection Element Update Online* No
Collection Plan Creation Online Yes
Collection Plan Update Online Yes
Specification Creation Deferred Yes
Specification Organization Assignment Online No
Specification Update Online Yes
Quality Result Creation Online**
Deferred
Yes
Quality Result Update Online**
Deferred
Yes
Nonconformance Creation Online* Yes
Nonconformance Update Online* Yes
Nonconformance Header Approval Deferred Yes
Nonconformance Detail Approval Deferred Yes
Disposition Creation Online* Yes
Disposition Update Online* Yes
Disposition Header Approval Deferred Yes
Disposition Detail Approval Deferred Yes
Corrective Action Creation Online* Yes
Corrective Action Update Online* Yes
Corrective Action Approval Deferred Yes
Corrective Action Review Approval Deferred Yes
Corrective Action Implementation Approval Deferred 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.

** You can enable deferred e-signatures when entering or updating quality results directly and when entering or updating quality results for the following three transactions. See: Creating Collection Plans.

Collection Element Creation or Update

The Collection Elements window starts the e-record capturing process whenever a collection element is created or changed (See: Defining Collection Elements). Select eRecord Details from the Tools menu to view the e-record associated with the collection element.

Collection Plan Creation or Update

The Collection Plans window starts the e-record and e-signature capturing process whenever a collection plan is created or changed (See: Creating Collection Plans). You can sign the e-signature to save the new or changed plan. Select eRecord Details from the Tools menu to view the e-record associated with the collection plan.

Important: You can also create collection plans using the Copy Collection Plans process (See: Setup Steps, Oracle Quality Implementation Guide, Step 2 - Copy from Template Collection Plans). These instructions explain how to copy a seeded template collection plan, but are valid for user-defined collection plans as well. When using this method to create collection plans, no e-record or e-signature is captured. To capture the e-record and e-signature, you must first create the plan using the Copy Collection Plans process. When you enter the new plan name, you must also check the Create Plans as Disabled box. This box only appears when the profile option value for EDR: E-Records and E-Signatures is Yes. Once you have created the new plan, open it in the Collection Plans window, change the date range in the Effective fields to valid dates, then save the plan. This triggers the collection of an e-record and e-signature.

Specification Creation

The e-record and e-signature capturing process starts after a specification is created and you select Request eSignature Approval from the Tools menu in the Specifications window (See: Defining Specifications). The specification has a status of Draft until you request e-signature approval. You can enter your signature online, while the event is happening in the window or in deferred mode. Any users responsible for additional required signatures receive workflow notifications informing them that their e-signature must be entered before the specification is approved for use. The workflow notification includes links to the e-record. You can view the status of the specification at any time. The Status field in the Specifications window shows whether the specification is draft, pending approval, approved for use, rejected, or no approval required. Select eRecord Details from the Tools menu to view the e-record associated with the specification.

Specification Organization Assignment

The Organization Assignment window starts the e-record and e-signature capturing process whenever a specification is assigned to or removed from an organization (See: To create new specifications linked to an existing specification). Select eRecord Details from the Tools menu to view the e-record associated with the organization assignment.

Specification Update

The Specifications window starts the e-record and e-signature capturing process whenever a specification is changed (See: Defining Specifications). You can sign the e-signature to save the updated specification. Select eRecord Details from the Tools menu to view the e-record associated with the specification.

Quality Result Creation or Update

The Enter Quality Results window starts the e-record and e-signature capturing process whenever quality results are entered directly or changed (See: Entering Quality Results Directly and Updating and Deleting Quality Results). You can sign the e-signature to save the new or changed quality results. When you enter quality results during another transaction (See: Quality Data Collection During Transactions), then the e-record and e-signature capturing process rules for the main transaction take precedence in most cases. For example, if you enter quality results while performing a WIP Move transaction, the e-record for the WIP Move transaction contains the WIP Move transaction information and the quality results. The exceptions where the quality data is stored in a separate e-record from the transaction e-record include the following transactions:

When entering quality results directly, you can choose whether to create an e-record and e-signature for each quality result row entered or one e-record and e-signature for all rows entered per collection. You make this choice in the Record Option field when you enter or update a collection plan (See: Creating Collection Plans). Capturing e-records and e-signatures by row is recommended for most cases and required for nonconformance and corrective action collection plans. Consider capturing an e-record and e-signature per collection when your plan meets the following criteria:

E-records and e-signatures captured when you update quality results are always captured by row.

Caution: Always update and save quality results one row at a time to ensure accurate e-records. This avoids the possibility of problems occurring when you update multiple rows. For example, if you approve some e-record rows and reject others, then save all of them, it is possible for the e-records of rejected results to be saved (since a partial rejection is not possible for online signatures). Therefore, it is strongly recommended that you update and save quality results one row at a time for e-record purposes.

If you accidentally update multiple rows, then save, but must reject one or more of the quality result e-records, then use the Cancel button on the e-signature page to terminate the process, instead of closing the browser page. This properly rolls back the e-signature process.

When you enter quality results for Parent-Child collection plans, the Record Option field setting in the parent plan takes precedence over the setting in the child plan (See: Parent-Child Collection Plans). For example, a parent plan requires capturing e-records and e-signatures by collection and its child plan requires capturing e-records and e-signatures by row. If you enter quality results into the parent plan, then only one e-record and e-signature is captured for all rows entered and the e-record contains all child plan results pertaining to the parent plan. If you enter quality results directly into the child plan, then e-records and e-signatures are captured for each row entered into the child plan (and no e-record or e-signature is collected for the parent plan). If you update a child row that is related to a parent row or other child rows, all of the related rows are captured by the e-record generated as well.

Nonconformance and Corrective Action Events

You can only generate e-records and e-signatures for nonconformance, disposition, and corrective action events when two conditions exist:

Nonconformance Creation or Update

The Enter Quality Results and the Update Quality Results windows capture an e-record when you enter or update a nonconformance result in a copy of a nonconformance template.

Nonconformance Header Approval and Detail Approval

The Enter Quality Results and the Update Quality Results windows can require an approval for a nonconformance if you enter Yes in the eSignature Required collection element field (See: Logging the Nonconformance, Oracle Quality Implementation Guide) in a copy of either the Nonconformance Master or the Template Nonconformance Detail collection plan. The Request eSignature and eSignature Status collection elements are disabled in the nonconformance templates, so you must enable them in your copy of the template if you require a nonconformance approval. You can enter your signature online, while the event is happening in the window or in deferred mode. Any users responsible for additional required signatures receive workflow notifications informing them that their e-signature must be entered. You can view the status of the nonconformance result at any time. The eSignature Status collection element, viewable using the Workbench - View Nonconformance page, shows whether the nonconformance result is pending, approved, rejected, or no approval required.

Disposition Creation or Update

The Enter Quality Results and the Update Quality Results windows capture an e-record when you enter or update a disposition result in a copy of a disposition collection plan template. Updates to dispositions include action assignments, implementing, correcting and resubmitting, and closing dispositions.

Disposition Header Approval or Detail Approval

The Enter Quality Results and the Update Quality Results windows can require an approval for a disposition if you enter Yes in the Request eSignature collection element field (See: Disposition Lifecycle, Oracle Quality Implementation Guide) in a copy of either the Template Disposition Header or the Template Disposition Detail collection plan. The Request eSignature and eSignature Status collection elements are disabled in the disposition templates, so you must enable them in your copy of the template if you require a disposition approval. You can enter your signature online, while the event is happening in the window or in deferred mode. Any users responsible for additional required signatures receive workflow notifications informing them that their e-signature must be entered. The workflow notification includes the e-record. You can view the status of the disposition result at any time. The eSignature Status collection element, viewable using the Workbench - View Nonconformance page, shows whether the disposition e-signature status is pending, approved, rejected, or no approval required.

Corrective Action Approval

Quality result entry into a copy of a corrective action request collection plan template triggers the capture of an e-record. The Enter Quality Results and the Update Quality Results windows can also trigger an approval for a corrective action if you enter Yes in the Request eSignature collection element field. (See: Corrective Action from an Audit, Oracle Quality Implementation Guide). If you trigger the e-signature process, you can enter your signature online, while the event is happening in the window or in deferred mode. Any users responsible for additional required signatures receive workflow notifications informing them that their e-signature must be entered. The workflow notification includes the e-record. You can view the status of the corrective action result at any time. The eSignature Status collection element, viewable using the Workbench - View Corrective Action Request page, shows whether the corrective action result is pending approval, approved for use, rejected, or no approval required.

Corrective Action Creation and Update

You capture an e-record when you create and update a Corrective Action collection plan or this plan's children in the Update Quality Results window.

Corrective Action Review Approval

Quality result entry into a copy of the Corrective Action Request Review collection plan template triggers the capture of an e-record when the Request eSignature collection element is set to Yes. The Enter Quality Results and the Update Quality Results windows can also trigger the approval of a corrective action review if you enter Yes in the Request eSignature collection element field. (See: Corrective Action Process Flow, Step 2, Oracle Quality Implementation Guide). If you trigger the e-signature process, you can enter your signature online, while the event is happening in the window or in deferred mode. Any users responsible for additional required signatures receive workflow notifications informing them that their e-signature must be entered. The workflow notification includes the e-record. You can view the status of the corrective action review at any time. The eSignature Status collection element, viewable using the Workbench - View Corrective Action Request page, shows whether the corrective action review is pending approval, approved for use, rejected, or no approval required.

Corrective Action Implementation Approval

Quality result entry into a copy of the CAR Actions Implementation collection plan template triggers the capture of an e-record when the Request eSignature collection element is set to Yes. The Enter Quality Results and the Update Quality Results windows can also trigger the approval of a corrective action implementation if you enter Yes in the Request eSignature collection element field. (See: Corrective Action Process Flow, Step 4, Oracle Quality Implementation Guide). If you trigger the e-signature process, you can enter your signature online, while the event is happening in the window or in deferred mode. Any users responsible for additional required signatures receive workflow notifications informing them that their e-signature must be entered. The workflow notification includes the e-record. You can view the status of the corrective action implementation at any time. The eSignature Status collection element, viewable using the Workbench - View Corrective Action Request page, shows whether the corrective action implementation is pending approval, approved for use, rejected, or no approval required.

Related Topics

21 CFR Part 11 Overview

Viewing Oracle E-Records and E-Signatures

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 Quality