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1-1 Electronic Records and Signatures (ERES) - How They Work - New in 11i10 NCOUAG Training Day February 28, 2005 Larry Gray Principal Consultant DARC Corporation 312- 338-5000 l [email protected]

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ERES Implementation

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Page 1: Oracle ERES

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Electronic Records and Signatures (ERES)

- How They Work - New in 11i10

NCOUAG Training DayFebruary 28, 2005

Larry GrayPrincipal ConsultantDARC Corporation 312-338-5000

[email protected]

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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 don’t 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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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)

ERES Transactions & Events in 11i.10

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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: E-Records 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 SignaturesUsing 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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For the transaction to be accepted the user must input their User Name and password for electronic signatures.

Electronic Records and SignaturesUsing ERES

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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 E–Records 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 E–Records Developer’s Guide• FDA Web Page

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Electronic Records and Signatures (ERES)

- How They Work - New in 11i10

Questions – Comments?

Larry GrayPrincipal ConsultantDARC Corporation 312-338-5000

[email protected]