Electronic Records, 21 CFR Part 11 and Oracle 9i Shon Naeymirad Principal Analyst/DBA Abbott...
-
Upload
gillian-drudge -
Category
Documents
-
view
223 -
download
1
Transcript of Electronic Records, 21 CFR Part 11 and Oracle 9i Shon Naeymirad Principal Analyst/DBA Abbott...
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