Electronic Records, 21 CFR Part 11 and Oracle 9i

Shon NaeymiradPrincipal Analyst/DBAAbbott Laboratories

Agenda

21 CFR Part 11 Electronic Record Electronic Signature How to build the final rule of 21 CFR Part 11 J2EE Platform Overview Oracle Application Development Framework (ADF)

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

21 CFR Part 11 [Docket No. 92N–0251] RIN 0910–AA29

Electronic Records; Electronic Signatures

•1991, members of the pharmaceutical industry met with the agency to determine how they could accommodate paperless record systems under the current good manufacturing practice (CGMP) regulations in parts 210 and 211 (21 CFR parts 210 and 211). FDA created a Task Force on Electronic Identification/Signatures to develop a uniform approach by which the agency could accept electronic signatures and records in all program areas.

•1992, report, a task force subgroup, the Electronic Identification/Signature Working Group, recommended publication of an advance notice of proposed rulemaking (ANPRM) to obtain public comment on the issues involved.

•1994. A complete discussion of the options considered by FDA and other background information on the agency’s policy on electronic records and electronic signatures can be found in the ANPRM and the proposed rule.

•1997, The final rule provides criteria under which FDA will consider electronic records to be equivalent to paper records, and electronic signatures equivalent to traditional handwritten signatures. Part 11 (21 CFR part 11) applies to any paper records required by statute or agency regulations and supersedes any existing paper record requirements by providing that electronic records may be used in lieu of paper records. Electronic signatures which meet the requirements of the rule will be considered to be equivalent to full handwritten signatures, initials, and other general signings required by agency regulations.

21 CFR Part 11 : Electronic Records; Electronic Signatures

Complaint Form

Reporter Name:

Event Description:

Event Date:

Blank Form = context

Data = content

Form + Data = record

Reporter Name: Jim Smith

Event Description: Patient Infection

Event Date: January 10, 2001

Paper Record

Database Records

Database Record Data Definition

Complaint Table

Complaint ID Number(10) Unique ID for complaint table

Reporter ID Number(10) Foreign Key to Reporter Table

Complaint Desc Varchar2(4000) Description

Complaint Date Date Date of Call

Days Open Number(6) Calculated Field

Electronic Record - Context

Electronic Record - Content

Electronic RecordsElectronic Record Context =

Reporter.Name

Complaint.Complaint Description

Complaint.Date

Electronic Record Content =

Jim Smith

Patient Infection

January 10, 2001

Electronic Record: Context + Content =

Reporter.Name: Jim Smith

Complaint.Complaint Description: Patient Infection

Complaint.Date: January 10, 2001

Paper vs. Electronic Records

Complaint Form

Reporter Name: Jim Smith

Event Description: Patient Infection

Event Date: January 10, 2001

Electronic Record Context =

Reporter.Name

Complaint.Complaint Desc

Complaint.Date

*Record definition includes 2 tables and 3 fields but excludes 8 fields in those tables plus all fields in the address table.

Electronic Record = Paper Record

Reporter.Name: Jim Smith

Complaint.Complaint Desc: Patient Infection

Complaint.Date: January 10, 2001

You must define the context of the electronic record (i.e., the collection of fields and tables that comprise the record) independent of the underlying database structures.

Otherwise, you risk the interpretation that all information in the database is part of the “electronic record.”

Key Point

As with any definition we need to store that definition so it can be applied consistently and referred to when is needed.

Attestation, simply stated, is attesting to the fact that a person changed a record, and links the record to the person who changed it, and when the change occurred.

A signature, on the other hand, implies approval, acceptance, or authorization (like signing a check, to authorize your bank to release funds).

Attestation vs. Signature

Key Point:

Your software should differentiate between attestation and signature since you need attestation on all required records but signatures only on certain records as defined by predicate rule.

“Don’t allow IT to define what records to apply signatures.”

Time Zone

UTC

• Establish a procedure for determining the local date and time from a time stamp based on UTC, Coordinated Universal Time.

• Coordinated Universal Time replaces Greenwich Mean Time to represent the Earth's prime meridian (0 degrees longitude). UTC is based upon the atomic time scale that is commonly referred to as GMT. In 1970 the International Telecommunication Union agreed upon a single acronym for use in all languages to be UTC.

• Oracle server date and time must be set to UTC.

How to build the final rule of 21 CFR Part 11 System

Understand system requirements Design good data model Define security roles Enforce password change Build Audit Trail for all tables Select your framework Automate your development Performance tuning

Build Audit Trail

Create history table for all tables Use database insert, update, delete triggers to

build history records Record user, server date and time Define your Electronic Record Define approval process of Electronic Record Build a mechanism to record versioning for

your Electronic Records

Oracle Security• From the authentication standpoint, Oracle’s Single

Sign-On (SSO) Server provides a scalable and extensible solution to address Web-based SSO.

• Oracle ID and password can be used as Electronic Signature.

• Use Oracle Profile to enforce password expiration, re-use control and complexity.

• Use Oracle Roles to control user access

• Oracle database instance login trigger can be used to monitor all logins.

• Time stamps must be stored with electronic signature.

Oracle9iAS Security Components

Single

Sign-On

Oracle

InternetDirectory

mod_ossl

Client

Oracle HTTP Server

JAAS

OC4J

mod_osso

Oracle9iAS JAAS Provider Integration with OC4J and SSO/OID

Oracle Profile

CREATE PROFILE “NEWUSER" LIMIT CPU_PER_SESSION DEFAULT CPU_PER_CALL DEFAULT CONNECT_TIME DEFAULT IDLE_TIME DEFAULT SESSIONS_PER_USER DEFAULT LOGICAL_READS_PER_SESSION DEFAULT LOGICAL_READS_PER_CALL DEFAULT PRIVATE_SGA DEFAULT COMPOSITE_LIMIT DEFAULT FAILED_LOGIN_ATTEMPTS 5 PASSWORD_LOCK_TIME 90 PASSWORD_GRACE_TIME 1 PASSWORD_LIFE_TIME .0006 PASSWORD_REUSE_MAX 10 PASSWORD_REUSE_TIME UNLIMITED PASSWORD_VERIFY_FUNCTION VERIFY_FUNCTION

Logon Trigger

CREATE TRIGGER "SYSTEM"."LOGON_CHECK" AFTER LOGON ON DATABASE Begin -- Limit access -- Verify usage of tools that was used to logon -- Insert into appl_audit_tables end;

J2EE Platform Overview

Open standard supported by a community process

Backed by Big names like Oracle, IBM, Sun Architecture for Highly scaleable multi-tier

enterprise applications Extends java promise for “Write Once, Run

Anywhere" portability

J2EE Platform Roles

Product Provider – supplier of container e.g. Oracle

Tool Provider – supplier of tools for development and packaging

Application Developer Application Assembler Application Deployer System Administrator

Oracle9i Application Server Release 2

Productive Development– Complete J2EE, Web Services– Lightweight J2EE Footprint

Most Reliable Deployment– Fast Application Server– High Availability and Clustering– Complete Management and Security

100% Standards Compliant– J2EE 1.3, Web Services, SOAP, WSDL,

UDDI, ebXML, RosettaNet, LDAP, SSL, XML ...

J2EE Architecture

Presentation

JSP,Servlet,

Custom Tags

Business

Logic

EJB,

Java Classes

Database &

Enterprise

Information

System

JDBC,

SQLJ,

JCA,

J2EE ServicesJNDI, JTA, JMS, JAAS, JAF,

JavaMail, JAF, JAXP

Oracle9iAS Architecture

Web

Container

JNDI

JMS

EJB

Container

AJP13

ORMI

JDBC

JTA

JavaMail

JAF

mod_oc4j

Client

EJB Client

Oracle HTTP Server

ORMI

AJP

HTTP

Oracle9iAS Containers for J2EE (OC4J)

JAAS

J2C

Model View Controller (MVC)

Persistence Layer

Object-relational Impedance Mismatch

Factor J2EE Relational Databases

Logical DataRepresentation

Objects, Methods, Inheritance

Tables, SQL, stored procedures

Scale Hundreds of megabytes Gigabytes, terabytes

Relationships

Memory references Foreign keys

Uniqueness Internal object id Primary keys

Key Skills Java development, objectModeling

SQL, Stored Procedures, dataManagement

Tools IDE, Source code management, Object Modeler

Schema designer, query manager, performance profilers, database Configuration

Oracle ADF Application Architecture

Oracle9iAS Integration

Summary

Your software should differentiate between attestation and signature.

You should define the context of the electronic record independent of the underlying database structures.

You must link the attestation, or person who created, modified or deleted the record, to the correct revision of the record. This audit trail functionality is required.

Design your electronic record around approval process

Select your framework for J2EE

Use existing tools to integrate and automate

AQ&Q U E S T I O N SQ U E S T I O N S

A N S W E R SA N S W E R S