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

lgray@darc.com
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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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 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: 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 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 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 Gray
Principal Consultant
DARC Corporation 312-338-5000

lgray@darc.com
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