copyright © 2005, sas institute inc. all rights reserved. maintaining a validated sas toolset...

Copyright © 2005, SAS Institute Inc. All rights reserved.

Maintaining a Validated SAS Toolset

Co-Presenters: Edward Helton and Patricia Halley

Copyright © 2005, SAS Institute Inc. All rights reserved. 2

db

LIS

HIS

lab, ADT, meds, source documents

display

eCRF

complete chart note

Merged workflow: clinical trial data captured in initial CDA, re-used in chart note

validation

Proposed processes (single source)

CLINIC CRO

ODM

CDA & CDISC in Starbrite Trial

CDA(1)

CDA(2)

Source: Liora Alschuler, Landen Bain, Rebecca Kush, PhD.


Near-term Goal: Create means of conversion to minimize risk of ODM adoption


Agenda

Part 11 and the Predicate Rules

Applying the Predicate Rules to Maintenance of a Validated SAS Toolset

Support from SAS (now and future)


Common Threads of GxPs

Calibrate

Test

Validate

Standardize

Retain Records

Maintain Written Procedures

Update on Part 11Update on Part 11 GMP by the SeaGMP by the SeaAugust 25, 2004August 25, 2004

Rick Friedman, Team LeaderGuidance & Policy

Division of Manufacturing and Product QualityOffice of Compliance, CDER


FDA Regulation References - GCP

Strong New FDA Industry Guidances in GCPs

50.20 – 312.56 ( c) – sponsors shall review and evaluate evidence related to safety and effectiveness

312.57 (a) – Records must be Accurate & Complete

312.62(a,b,c) – Investigator Recordkeeping - drug disposition, case histories, record retention


FDA Regulation References - GMP

211.22 (a) – Quality control unit has the authority to approve and reject

211.67 ( c) – Records shall be kept of maintenance, cleaning, sanitizing, and inspection

211.68 – Validation requirements of automated equipment

211.100 (a) - Written procedures for production and process control

211.180 (a), (b), and ( c) – Retention period for records


FDA Regulation References - GLP

58.29 (b) – must maintain current summary of training for those engaged, or supervising the conduct of a non-clinical study

58.33 (b) – all experimental data… must be accurately recorded

58.35 (b) (4) – periodically submit a written status report noting problems and corrections

58.63 ( c) – records maintained of all inspections, maintenance records, testing, calibration and/or standardizing operations


FDA Regulation References - Devices

21 CFR 812.145 (a) & (b) - Records must be Accurate & Complete

21 CFR 812.140 – must retain records required by 812


21 CFR Part 11- Upcoming Amendment

Comments collected on the existing rule

Support for Part 11 in general

It is not going away – expect rewrite in future


Standard Data / JANUS

Tools to receive, upload and analyze data

Unambiguous path of the source data to the analysis findings (metadata, derivations, flags, imputations, source code, analysis files)

Focus on standard data and standard analysis makes maintaining validation even more critical – valid interface, interaction between SAS systems

This makes your SAS configuration even more important!


Standard Data / JANUS

Right now it takes analysis of many applications to find common trends.

One study took 10 person years.

We don’t have that kind of time to “find” the right data.

Standardization enhances the need for a validated SAS system.


SAS Validation of SAS9

Customer Validation of SAS9 -- Toolset

Validated System

AERS Interim Analysis Integrated Safety Report

Customer Validation of SAS9 -- Applications


Policies and Procedures

Staff Qualification

ConfigurationManagement

SecurityDisaster

Recovery


Configuration Management

Identify functional and physical characteristics

Manage changes to those characteristicsSource -- IEEE


Implement/Verify

Request/A

pproveDocument

Managing Changes


Identify and Describe Changes Sources of Information

• Tech Support

• SAS Notes

• Mail & File Lists (TSNEWS-L)

• Monitoring Tools

Sources of SAS Updates• Hot Fixes

• Service Packs

Identify/D

escrib

e

Implement/Verify

Request/A

pproveDocument


Identify and Describe Changes - Future

Electronic Software Downloads

i

SAS UpdatesAvailable Automatic Alert Notification


Request and Approve Changes

Classify Change

Submit Request

Obtain ApprovalIdentify

/Desc

ribe

Implement/Verify

Request/A

pproveDocument


Implement and Verify Changes

Test environment

SASIQ/SASOQ

Data Migration

Identify/D

escrib

e

Implement/Verify

Request/A

pproveDocument

Copyright © 2005, SAS Institute Inc. All rights reserved. 27Copyright © 2003, SAS Institute Inc. All rights reserved.

SASIQ/SASOQ

Automated

Tested

Repeatable

Reports and Stores Results (XML)

http://support.sas.com/rnd/migration/planning/validation/





Data Migration

Proc Migrate

Migration Macros

Guidance and tools available at

http://support.sas.com/rnd/migration/fulltoc.html




Implement and Verify Changes – Future

IQ/OQ Enhancements

Install Enhancements

Less media (1 instead of 19)


Document

Initial Change Requests

IQ/OQ Output

SAS Logs

SAS Registry (Future)

Design / Configuration Specification Change Log


Security

Physical

Logical• Operating System Level

• Account Maintenance

• Internet Security

• SAS Management Console


Business Continuity Backups

Redundancy

Environmental Controls

Disaster Recovery

End-to-End Seamless Integration; Semantic Interoperability

Pharma

Medical & StatisticalReviewers

Approval

Open Data Model - XML based, CDISC compliant

Patients

Subject

CDMSOp DB

Investigator

Physician

ODM SDTM

LAB ADaM

Source: Dave Iberson-Hurst

copyright © 2005, sas institute inc. all rights reserved. maintaining a validated sas toolset...

Documents

sas institute

records slide

future slide

b records

cder slide

c records

written procedures slide

maintenance records