MVP Workshop – IVT April 2013

Master Validation Plan

Dr. Teri Stokes, GXP International,

Concord, MA – USA

www. GXPInternational.com Email: gxpintl@rcn.com

What is aVMP?

• Validation Master Plan (VMP):

Outlines the principles involved in the

qualification of a facility, defining the areas

and systems to be validated, and provides a

written program for achieving and maintaining

a qualified facility. It should include process

validation, facility and utility qualification and

validation, equipment qualification, cleaning

and computer validation. It drives a structured

approach to validation projects. (Wikipedia)

Slide 15

What is an MVP?

• Master Validation Plan (MVP):

Defines the areas with systems to be validated,

and provides a written program for achieving

and maintaining computerized systems to GXP

requirements. MVP should include OQ, IQ,

and PQ validation efforts for GXP compliance.

It drives a consistent, structured approach to all

computer validation projects.

• MVP has a qualifying analysis form for

identifying systems to be under its directives.

Slide 15

Validation Package Definitions

• Operational Qualification (OQ) – Documented evidence

that a system operates as intended throughout its expected

range as per functional design specifications. (Supplier Team)

• Installation Qualification (IQ) – Documented evidence that

all system components are installed to supplier instructions &

user requirements. (Infrastructure/IT Team)

• Performance Qualification (PQ) – Documented evidence

that a system operates as intended in the user’s work process.

(User Team – Start-up & Ongoing)

Slide 38

VMP, MVP, VP and VSR

• Validation Master Plan (VMP): to set a

standard approach for facility, products,

process, and systems qualification

– Master Validation Plan (MVP): to set a standard

approach for IQ/OQ/PQ computer validation for

systems in a designated GXP area

• Validation Plan (VP): to define the approach for

validation of a specific system for OQ, IQ, or PQ

• Validation Summary Report (VSR):

to describe results, issues, and status

Slide 5

Validation Package Model

Control of Software &

Platform Environment

Package Plan Verification/Validation Plan

Control of System & SW

Changes & Audit of

CSV Package, QMS

Package Summary Report Verification/Validation Summary Report

Standard CSV

package

SOPs, Training &

Materials for Human

Work with System

Prepared and maintained by a CSV Package Team for IQ, OQ, or PQ

Requirements &

Specifications for SW,

System & Services

Slide 24

1. System Control 2. Human Control 3. Testing Control

Validation Package Model

Control of Software &

Platform Environment

CSV Package Plan Verification/Validation Plan

Control of System & SW

Changes & Audit of

CSV Package, QMS

CSV Package Summary Report Verification/Validation Summary Report

Standard CSV

package

SOPs, Training &

Materials for Human

Work with System

Prepared and maintained by a CSV Package Team for IQ, OQ, or PQ

Requirements &

Spec.s for SW, System

& Services - SLA

Slide 30

1. System Control 2. Human Control 3. Testing Control

Test PlansStartup & Ongoing

Test Cases, Scripts,

Data & Result Logs

Test Summary

Reports

QMS = Quality Management System SLA = Service Level Agreement

Trace

Corporate Structure for GXP Compliance

MVP for a GXP

Group of systems

3. System level

CSV Packages

& procedures

1. Corporate policy and

procedures

2. Project/Group level

plans

Per system Users’ PQ

PackageLocal SOPs

•Dept.

•Work ProcessSystem SOPs

User SOPs

MVP for IT

platforms

Supplier’s

OQ Pkg.VP Pkg. Plan

VP Package Summary ReportValidation

Package Teams

Platform

IQ Pkg.

Global Regulations

& StandardsMHW, FDA, EU, ISO, IEEE...

CV Policy/VMP Company Management

CSV SOPsMVP for a

SW Project

IEEE Format for a Software V&V Plan

IEEE Std. 1012-1986

1. Purpose

State plan identifier. Describe system. State assumptions and scope for this plan. What’s included, excluded, and limited?

2. Referenced Documents

Identify key documents associated with plan activities.

3. Definitions

Define terms and acronyms needed to understand this Plan.

4. Verification & Validation (V&V) Overview

Team structure, master task schedule, assigned responsibilities, tools, techniques, and methodologies to be used for tasks.

Slide 25

IEEE Format for a Software V&V Plan

IEEE Std. 1012-1986

5. Life-Cycle Verification & Validation (V&V)

Management of V&V, concept phase, requirements phase, design phase, implementation phase, test phase, installation and checkout phase, operation and maintenance phase, retirement/decommission phase

6. Software Verification & Validation Reporting

Required reports, optional reports

7. Verification & Validation Administrative Procedures

Anomaly reporting and resolution, task iteration policy, deviation policy, control procedures, standards, practices, and conventions

Slide 26

1. Package Summary Report identifier - Unique ID traceable to associated Validation Plan.

2. Summary of all Life Cycle Tasks - Identifies CSV Package Team. Includes Task List from Validation Plan with updated status and roles responsible. References Audit Reports and/or Test or Package Summary Reports to cover Platform and Application Provider phases of Life Cycle.

3. Summary of Anomalies and Resolutions - Describes any deviations from Validation Plan and reasons why. Highlights any anomalies pending from the Test Summary Report.

CSV Package Summary Report

IEEE Std. 1012-1992 Adapted

Slide 55

CSV Package Summary Report

4. Assessment of overall software quality - Discusses

assumptions and limits to scope of CSV Package. Gives

highlights from Test Summary Report. Describes how Package

items are sufficient to assess system quality and user readiness

for Go-Live in a regulated environment.

5. Recommendations - Recommends a Go-Live release status

to the System Sponsor as Full Pass, Pass with Specified

Conditions, or System Fail.

6. Approvals - Names, titles, signatures, dates and meaning of

signatures.

7. Appendix - Table of Contents to list Package items.

IEEE Std. 1012-1992 Adapted

Slide 56

OECD GLP – Acceptance Testing

• “…there should be evidence that the

system was adequately tested for

conformance with acceptance criteria …

prior to being put into routine use.”

• “Formal acceptance testing requires the

conduct of tests following a pre-defined

plan and retention of all testing

procedures, test data, test results, a

formal summary of testing, and a record

of formal acceptance.”

Slide 27

IEEE Format for a Software Test Plan

Software Test Plan Outline - IEEE Std. 829-1983

1. Test plan identifier

2. Introduction

3. Test items

4. Features to be tested

5. Features not to be tested

6. Approach

7. Item pass/fail criteria

8. Suspension criteria & resumption requirements

Slide 28

IEEE Format for a Software Test Plan

Software Test Plan Outline - IEEE Std. 829-1983

9. Test deliverables

10. Testing tasks

11. Environmental needs

12. Responsibilities

13. Staffing and training needs

14. Schedule

15. Risks and contingencies

16. Approvals (IEEE Tel: 800-678-4333)

Slide 29

Test Plan Summary Report

1. Test Summary Report Identifier - Unique ID traceable to

associated Test Plan.

2. Summary - Describes items tested (application version), test

environment (platform system), and test documentation used (Test Cases,

Test Scripts, T.S. Envelope contents).

3. Variances - States any deviations from Test Plan or Test Scripts and

reason why.

4. Comprehensive Assessment - Discusses assumptions and limits

to scope of testing. Were scope of testing and results obtained sufficient to

assess system reliability? Discuss reasons for limits chosen.

IEEE Std. 829-1983 Adapted

Slide 37

5. Summary of Results - Gives table of testing results per Test Case.

Table of anomalies and their resolutions. List of outstanding issues and

risks (unresolved anomalies).

6. Evaluation - Pass/Fail conclusion based on test results and criteria

in the Test Plan.

7. Summary of Activities - Tester/Witness staffing, task list from

Test Plan with updated status.

8. Approvals - Names, titles, signatures, dates and meaning of

signatures.

9. Appendix - Table of Contents list for test documentation

Test Plan Summary Report

IEEE Std. 829-1983 Adapted

Slide 38

CSV Package Team Model – Any Package

Package Sponsor

Test Coordinator

Package Manager

(Pkg. QC)

CSV Package Team

Quality

AssuranceTeam Leader

Ad hoc

Members

Trains Team and

Audits CSV Pkg.

Funds and Approves

Validation Work

Team to Develop and

Maintain a CSV Pkg.

Slide 31 Reference Stokes Article – Part 4.

Software Supplier’s (SDLC) OQ Package

Code & Tools Mgt. Logs,

SDLC, Controlled SW

Devel. Platform, Tools IQ

OQ Verification Plan

SW Upgrade Plan, Bug

Tracking, Audit Logs,

QMS with SQC & QA

OQ Verification Summary Report

Standard SW supplier’s

CSV package

SW Engr. SOPs, Pgmr.

Trng, Product Manuals,

User Help Desk

Prepared by internal or external software supplier team

MRS, FRS, SDD, Code,

SDLC Docs., Support

Contract (SLA), (Escrow)

Slide 32

1. System Control 2. Human Control

Reference Stokes Article – Part 3.

Software Supplier’s (SDLC) OQ Package

Code & Tools Mgt. Logs,

SDLC, Controlled SW

Devel. Platform, Tools IQ

OQ Verification Plan

Test Cases, Scripts,

Data & Result Logs

Master Test Plan &

Sub Test Plans –

U,F,S,M,S,I,R*

SW Upgrade Plan, Bug

Tracking, Audit Logs,

QMS with SQC & QA

OQ Verification Summary Report

Standard SW supplier’s

CSV package

SW Engr. SOPs, Pgmr.

Trng, Product Manuals,

User Help Desk

Prepared by internal or external software supplier team

MRS, FRS, SDD, Code,

SDLC Docs., Support

Contract (SLA), (Escrow)

Slide 33

Test Summary

Report (per Plan)

*U,F,S,M,S,I,R = Unit, Function, Smoke, Module, System, Interface, Regression

1. System Control 2. Human Control 3. Testing Control

Trace

Platform System IQ Package

Data Ctr. Config. Mgt.

Logs, Ops. SOPs, System

Manuals & Security WI

IQ Validation Plan

Dis. Rec. Plan, Change

Control Log, Backup &

Archive Logs, Supplier

Records, IT Audit Log

IQ Validation Summary Report

Standard platform

CSV package

IT/IS CVs, Training

Records, Dept. SOPs,

WIs, Check Lists

Prepared and maintained by IS/IT Department Team

Slide 34

2. Human Control 1. System Control

Reference Stokes Article – Part 2.

SLA, SLA Monthly

Reports, Security

Logs, Help Desk Log

Platform URS

Platform System IQ Package

Data Ctr. Config. Mgt.

Logs, Ops. SOPs, System

Manuals & Security WI

IQ Validation Plan

Test Cases, Scripts,

Data & Result Logs

IQ Test Plan(s)

Startup & Ongoing

Dis. Rec. Plan, Change

Control Log, Backup &

Archive Logs, Supplier

Records, IT Audit Log

IQ Test Summary

Report(s)

IQ Validation Summary Report

Standard platform

CSV package

IT/IS CVs, Training

Records, Dept. SOPs,

WIs, Check Lists

Prepared and maintained by IS/IT Department Team

SLA, SLA Monthly

Reports, Security

Logs, Help Desk Log

Platform URS

Slide 35

3. Testing Control 1. System Control 2. Human Control

Trace

Application User’s PQ Package

Applic. Admin. SOP &

Applic. Config. Mgt. Logs

PQ Validation Plan

Change Control Log,

QA Audit Log, Supplier

Reports & BDG* Minutes

PQ Validation Summary Report

Standard user’s

CSV package

User Manuals, CVs,

Trng Records, Work

SOPs, WIs, Help Logs

Prepared and maintained by User Department(s) Team

Needs Analysis, RFP,

Contract, URS, User

Access Profiles, SLAs

Slide 36

1. System Control 2. Human Control

Reference Stokes Article – Part 1.

Application User’s PQ Package

Applic. Admin. SOP &

Applic. Config. Mgt. Logs

PQ Validation Plan

Test Cases, Scripts,

Data & Result Logs

PQ Test PlansStartup & Ongoing

Change Control Log,

QA Audit Log, Supplier

Reports & BDG* Minutes

PQ Validation Summary Report

Standard user’s

CSV package

User Manuals, CVs,

Trng Records, Work

SOPs, WIs, Help Logs

Prepared and maintained by User Department(s) Team

Needs Analysis, RFP,

Contract, URS, User

Access Profiles, SLAs

Slide 37

PQ Test Summary

Reports

* BDG = Business Decision Group

1. System Control 2. Human Control 3. Testing Control

Trace

Xcalibur CSV Package – PQ Testing

XCAL-VP01

XCAL-TC05

XCAL-TC04

XCAL-TC03

XCAL-TC02

XCAL-TC01

XCAL-TP01

XCAL-TPSR01

XTC1.TS1

XTC2.TS1-TS4

XTC3.TS1-TS5

XTC4.TS1

XTC5.TS1-TS3

XCAL-URS01XCAL-CMLOG

XCAL-SOP(s)

XCAL-Trning

Materials &

Records

XCAL-OGTP

XCAL-Supplier

Audit Certificate

XCAL-VP Pkg.

Audit Certificate

XCAL-VPSR01 CSV Package Summary Report

XCAL-System

Manuals &

Online HelpXCAL-Part 11

Gap Analysis

Mgt. Control

System Control Test Control User Control

GXP System Life Cycle Model

2.SYSTEM PLAN

What? URS

3.DESIGN

How? SDD

4.BUILD

Program or

Configure

5.TEST

Verify to SDD

& Release

6.COMMISSION

Accept &

Validate to URS

9.RETIRE

Decommission

& Replace

Test Fit

to Design

Test Fit to

Work Process

8.MAINTAIN

Fix & Modify

7.OPERATE

Use & Monitor

1.SYSTEM IDEA

Needs Analysis

Report & RFP

Application

Life Cycle

SDLC

RFP – Request

for proposal

URS - User

requirements

specification

SDD - Software

design

description

Platform System

1.

Configure

2.

Install

3.

Test

Test Fit to Install Specs.

PQ

OQ

IQ

System User

Software

Supplier

SDLC - Software

Development

Life Cycle

Ongoing Testing for Change Control

2.SYSTEM PLAN

What? URS

3.DESIGN

How? SDD

4.BUILD

Program or

Configure

5.TEST

Verify to SDD

& Release

6.COMMISSION

Accept &

Validate to URS

9.RETIRE

Decommission

& Replace

Test Fit

to Design

Test Fit to

Work Process

8.MAINTAIN

Fix & Modify

7.OPERATE

Use & Monitor

1.SYSTEM IDEA

Needs Analysis

Report & RFP

Application

Life Cycle

SDLC

Platform System

1.

Configure

2.

Install

3.

Test

Test Fit to Design & Work

SDLC - Software

Development

Life Cycle

Software

Supplier

System User

Change

Symbol

System Focus in “Operation” Phase

Fit ?User/

Owner

Software

Supplier

Patches &

Updates

Application

Life Cycle

Use & Monitor

Fix & Modify

Re-Accept

7. Operate

8. Maintain

6. Commission

Application

Support SLA

Platform

Support SLA

Help Desk

C.M. Log

Platform

Business Decision Group (BDG) - Prioritize change & resources

Applic.

9. Retire

1. System availability

2. Install & test updates

3. Backup & restore

4. Manage capacity

Part 11/GLP Package Model

Control of Instrument &

Computer Components-

Config. Mgt. Logs

Validation Plan for

Instrument Type A

Test Cases, Scripts,

Data & Result LogsControl of System

Changes & Audit of

CSV Pkge & Audit Trail

CSV Package Summary Report

Standard CSV

package

SOPs, Training &

Materials for Analyst

Work with System

Prepared and maintained by a CSV Package Team

Specifications for

Method, Instrument,

System & Services

System Control Human Control

Test Summary

Report(s)

Testing Control

Type A Test Plan(s)Startup & Ongoing

MVP – Lab X

Master Plan Package Model

Control of Software &

Platform Environment

Master Validation

Plan – IQ or PQ

Control of System

Changes & Audit of

Work Process, QMS

Validation Summary Report

SOPs, Training &

Materials for Human

Work with System

Prepared and maintained by a CSV Package Team

Work Process

Requirements for

System

1. System Control 2. Human Control 3. Testing Control

Master Test Plans

Startup & Ongoing

Test Cases, Scripts,

Data & Result Logs

Test Summary

Reports

QMS = Quality Management System SLA = Service Level Agreement

Trace

Mini VP Form

per System

Mini TP Form

per System

What is Common Sense?

• Working Definition:

Common sense is knowledge based on “native

good judgment” and personal experience. It is

that combination of “book” smart, “street” smart,

and “work” smart that a person can apply to

scoping computer validation projects.

Slide 15

Any Questions or Comments?

??

Common Sense Computer Validation

MVP Workshop – IVT April 2013

Thank You

MVP

Coffee and Case Study #1

Appendix 6.2-6.4 for IQ MVP Examples

MVP for a

Group of systems

3. System level

CSV Packages

& procedures

1. Corporate policy and

procedures

2. Project/Group level

plans

Per system Users’ CSV

PackageLocal SOPs

•Dept.

•Work ProcessSystem SOPs

User SOPs

MVP for IT

platforms

Supplier’s

CSV Pkg.Pkg. Plan

CSV Package Summary ReportCSV Package

Teams

Pltfm.

CSV

Pkg.

Global Regulations

& StandardsMHW, FDA, EU, ISO, IEEE...

CSV Policy Company Management

CSV SOPsMVP for a

Project

IQ MVP CASE

STUDY 6.2-6.4

MVP Case Study

6.2 Example of an MVP for IQ of Regulated Platform

Systems in a CRO (Pages 168 - 181)

6.3 Template Form for Mini VP Form to be used per

Platform System under MVP (Pages 182 – 188)

6.4 Example of a completed Mini VP form for a

Pharmacovigilance/Data Management (PVDM) platform

system under the MVP (Pages 189-196)

6.7 Example of an IQ Validation Summary Report for the

PVDM Platform System

Use Book Chapter 6 – The IT Infrastructure Role in ValidationComputer Validation: A Common Sense Guide by T. Stokes

MVP Case Study

1. What advantage does this MVP approach bring to the CRO?

2. Is there any disadvantage to working this way?

3. Did the Validation Summary Report give a full review of this

IQ validation effort?

4. Were all the Mini VP tasks completed?

5. What issues arose and how were they resolved?

6. Was the system recommended for release?

7. How do the Mini documents and Summary Report relate to

the IQ MVP?

8. Where might you want to apply an MVP method in your

own company?

Use Book Chapter 6 – The IT Infrastructure Role in ValidationComputer Validation: A Common Sense Guide by T. Stokes