Electronic Records and Signatures (ERES) - How They Work New in 11i10

NCOUAG Training Day

February 28, 2005
Larry Gray Principal Consultant DARC Corporation lgray@darc.com
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312-338-5000

Agenda

Electronic Records and Signatures (ERES) History Description Transactions and Events How to Set up this Feature How to Use this Feature Resources

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History of Federal Drug Administration 21 CFR Part 11

Regulation First Proposed in 1997 Quality Systems Requirements 820 E-Signature = Hand Signature Process (OPM) Implements in 11i9 Discrete Releases in 11i10 Customers who dont comply with 21 CFR Part 11 can be fined or even shut down by the FDA

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Electronic Records and Signatures (ERES) Description

Medical device customers and other regulated industries can easily implement the ERES functionality where and how they need it. ERES has been enabled for critical business events or transactions that would affect the quality of the manufactured medical device and can be easily configured with the existing business flows in use. Eliminate Paper and it is good business sense to adopt ERES.

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Electronic Records and Signatures (ERES) Description

Medical device manufacturing customers are regulated by the FDA and regulation 21 CFR Part 11 requires that medical device manufacturers -computer records to be equivalent to hand signatures and strict security controls must be in place.

21 CFR Part 820 is the predicate rule which defines the functional requirements of a quality system.
21 CFR Part 11 defines the technical requirements to maintain electronic records and electronic signatures.

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Electronic Records and Signatures (ERES) Description

The electronic signature is a two-part entry. The first part is the signature user name that is input and then an additional password for that user is required to approve the record. This level of security is necessary for the FDA regulations to confirm that the person is authorized to sign the transaction is truly the one who completed the signature. If a PC was on and an unauthorized person happened by they could not complete the transaction without the additional password.

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Electronic Records and Signatures (ERES) Description

E-Records are captured in an XML format. XML provides portability, ultimately enabling the delivery of eRecords to the FDA electronically. XML also provides longevity of the data.

The eRecords are stored in an evidence store. The evidence store provides a secure storage location and links to the transaction window. The eRecords are generated using the XML data in an XSL format.

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Electronic Records and Signatures (ERES) Description

Oracle Discrete Manufacturing now has electronic records and signatures that helps medical device customers to comply with these FDA regulations. Electronic records and signatures are available for 55 events for users to pick which transactions are critical for their business cases and to implement record and signature control. Device History Record can be produced with ERES.

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Electronic Records and Signatures (ERES) Description

This ERES is for desktop forms only mobile and html transactions are not activated.

The main value to an implementer is only in getting rid of a paper based system. Is there a problem with retrieving the Work Order document from 1992?
Security is on two levels imbedded security and ERES passwords.

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Electronic Records and Signatures (ERES) Description

An On-Line transactions signature is one where the

transaction cannot be saved until a valid signature(s) are input. Online signatures are beneficial for those real-time processes that cannot proceed without immediate authorization.

Item master creation is an example of Online.

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Electronic Records and Signatures (ERES) Description

A Deferred e-signature transaction can be signed at different points of time by different people before the transaction completes. Many times the deferred signatures do require a workflow approval. If an e-Signature is not entered online, then a notification is automatically sent to the user responsible for signing that record. ECO approval is an example of deferred.

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Electronic Records and Signatures (ERES) Description

Electronic Records and Signatures (ERES) Modules Used
Engineering and Bill of Material Purchasing Quality WIP Inventory Shipping

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Electronic Records and Signatures (ERES) Description

Electronic Records and Signatures (ERES) Business Processes Supported
Concept to Release - New Product Introduction, Design Control & Design Changes Procure to Pay Purchasing Control & Receiving Demand to Build Device History Nonconformance Management Corrective Actions Processing Inventory Management

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ERES Transactions & Events in 11i.10

Items, BOM, Engineering ECO Creation and Update (ER, ES) ECO Approval (ER, ES) ECO Implementation, Schedule, Reschedule and Cancellation (ER, ES) Transfer and Copy to Manufacturing (ER, ES) Item Creation, Update, Organization Assignment (ER, ES) Item Revisions Entry (ER, ES) Item Cross References Entry (ER) Bill Creation and Update (ER, ES) Routing Creation and Update (ER, ES)

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ERES Transactions & Events in 11i.10

Quality Collection Element Creation & Update (ER, ES) Specification Approval (ER, ES) Collection Plan Creation & Update (ER, ES) Quality Results Entry & Update (ER, ES) Nonconformance Create, Update & App. (ER, ES) Disposition Creation, Update & Approval (ER, ES) Corrective Action Create, Update & App. (ER, ES)

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ERES Transactions & Events in 11i.10

WIP Job Assembly Move (ER, ES) Job Assembly Completion (ER, ES) Job Material Transaction (ER, ES)

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ERES Transactions & Events in 11i.10

Inventory Miscellaneous Transactions Miscellaneous Issue & Receipt (ER, ES) Account Issue & Receipt (ER, ES) Account Alias Issue & Receipt (ER, ES) Purchasing ASL Entry and Update (ER) Receiving Inspection, Transfer & Delivery with Quality (ER, ES) Shipping Delivery Close (ER)

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Electronic Records and Signatures (ERES) Setup

There are 4 steps in the setup Setup the ERES Profile Option (EDR: ERecords and E-Signatures) Approvals Management: Conditions, Approval Groups and Approval Rules Enable Subscriptions for the ERES Event Setup ERES Configuration Variables

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Electronic Records and Signatures (ERES) How to Setup this Feature

Approval setup starts with choosing the transaction that requires an electronic signature.

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Electronic Records and Signatures (ERES) How to Setup this Feature

A rule is setup to determine which conditions warrant the ERES.

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Electronic Records and Signatures Using ERES

When a transaction is ERES is enabled and the conditions are met then an e-record is produced and the information can be reviewed prior to signature.

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Electronic Records and Signatures Using ERES

For the transaction to be accepted the user must input their User Name and password for electronic signatures.

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Electronic Records and Signatures (ERES) Dependencies and Interactions

11i10 Installed Quality Installed (Shipping and NC, CAR) Oracle ERES Framework AME Approval Management Framework Workflow Oracle XML Gateway

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Electronic Records and Signatures (ERES) Resources

Quality Users Guide 11i10 (page 440 458) 11i10 RCD for Quality (First 16 Pages) Oracle ERecords Implementation Guide B10633-02 If you have never used Oracle E-Records, Oracle suggests you attend one or more of the Oracle E-Records training classes available through Oracle University. Oracle ERecords Developers Guide FDA Web Page

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Electronic Records and Signatures (ERES) - How They Work New in 11i10

Questions Comments?
Larry Gray Principal Consultant DARC Corporation lgray@darc.com
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312-338-5000