Successfully leveraging HP Quality Center for requirements management in a manufacturing environment

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Successfully leveraging HP Quality Centerfor requirements management in a manufacturing environmentIn the Life Science IndustryPaperless validation approachMichael Herløv Jensennne pharmaplan A/S

Kim Stenbo Nielsen, NNIT A/S

Successfully leveraging HP Quality Center for requirements management in a manufacturing

environmentIn the Life Science Industry

Paperless validation approach

HP Software Universe 2010 Session ID: 1533

Presenter : Michael Herløv Jensen, nne pharmaplan A/S

andKim Stenbo Nielsen, NNIT A/S

Presentation 2010

Today we are the worlds’ leading

consulting and engineering company in

the complex field of pharma and biotech.

We cover all segments from

biopharmaceuticals and vaccines to

medical devices and help our customers

develop, establish and improve their

product manufacturing.

NNE Pharmaplan employs close to

1,600 people at more than 25 locations

around the world.

Engineering for a healthier world – our

role in an industry that improves people’s

lives worldwide.

We want to be considered as a

Trusted Advisor

nne pharmaplan in brief

NNIT A/S – In brief

NNIT is one of the four largest providers of

IT services in Denmark

Focus areas: It consultancy, development,

implementation and operations

for regulated industries

Approx. 1,400 employees

Turnover in 2009 $ 290 million

Head office in Denmark - offices in five countries

Subsidiary of Novo Nordisk A/S

Our values: Open and honest. Conscience driven. Value adding.

Slide 5 Michael Herløv Jensen and Kim Stenbo Nielsen HP Software Universe 2010, Session ID: 1533

Agenda

The challenge

What is important for the client

The idea

The workflow

The concept

The solutions

Supporting documents & organisation

Any questions


The challenge

A life science client wants to expand the production facilities in

the far east

The production facilities shall be a “”copy” of the production

facilities in south America

In the Life Sciences industry there are very high requirements

to the level of documentation (validation)

All validation documents such as requirements, test Plans,

protocols, reports and deviations needs signature approval

from quality assurance department within the company.

The construction of the plant is on a very tight schedule since

each day of delay can result in loss of millions of dollars in

profit.


The challenge

The manufacture asked?

Why is the validation cost so expensive?

Is it possible to cut down the amount of

paper produced when executing validation?

Is it possible to obtain a better overview

- from start to the final user accepts?

Is it possible to use human resources from another country without

moving resources?

After investigating relevant technologies, HP Quality Center was

selected

New Approach with electronic Tool

Traditional paper validation



All requirements & related risks information should be stored together

All testing information should be in one structured place

Ensure easy communication and status during projects

Ensure future reuse of approved records (e.g. test plans) is easy

Ensure good traceability features

Easy to import or export data from many other tools

Possible to have project execution time 24 hours a day

Access from all around the world

Alignment of validation processes in all client sites

Easy handling of documentation generated outside the application – e.g.

attachments & screendumps

Control of equipment validation management

Customisation of folder structure, analysis and reporting



A factory

Production line 1

Production line 2

Prep Filling Inspection Packing

Prep InspectionFilling Packing





A process area

Production line 1 – The filling process

Washing

Machine

Tray

Load

Unit

TunnelDry cartridges

Fix silicone

Sterilisation

Lower temp

Filling

Machine

Equipment Validation Status:Requirements -Test - Result - Defect / changes


The Idea

Paperless validation with electronic signature

No requirements on paper.

No requirement traceability on paper

No test plans on paper

No test protocols on paper

No test reports on paper

No deviation report on paper

Basically:

No signatures on paper


Workflow - Request

We wish to have approval on the following:

Requirements

Equipment

Supplier

Document

Test Plans

Test Set

Test Protocol

Test Runs

Test Reports

Defects


”These statuses define

the “approval cycle”

Ready For Review

Rejected

Cancelled

In Progress Approved Superseded

eSig applied

Approval workflow


Approval workflow

Applies to:

Requirements

Test Cases

Test Sets

Runs

Defects


Roles

Role: Is responsible for:

Test case designer Creation of Tests and Defects

Test set designer Creation of Test sets and Defects

Tester Run of Tests and creation of Defects

Defect manager Handling of Defects

Approver, Approver

2, Approver 3

Approval of Requirements, Tests, Test sets, Runs, Defects and

creation of Defects

User administrator Creation of users in projects

Release manager Creation of Releases and Cycles and creation of Defects

Requirement author Creation of Requirements and creation of Defects

Viewer View all information


Electronic Signature 1

Signed with an electronic signature – compliant with 21 CFR Part 11

Author:

Approver(s):



Approver(s):




Key principles

Authors cannot approve own work

Test Runs must be signed by tester after test execution

When a record is approved it cannot be changed

Traceability between approved records are locked


Workflow overview (Qualification)

Test runEnd Run Signature

Test

Plan

Test Set

Defects

Test LabTester

Data reviewer

Re-run

All Runs

Requirements


The Concept forRequirements

We wish to control the following:

Paperless requirements, description, risk etc…

Production equipment validation status

Documentation & specifications

Shared requirements

Requirement classification


The Solution for Requirements

Define the suitable folder structure

For work packages and equipment


The Solution forRequirements

Requirement description


The Solution forRequirements

Link equipment to production requirements


The Concept for Releases


Test strategy for a piece of production equipment

When production equipment is subject for validation

(start & end date)

Which equipment test phases (cycles) are required (start

& end date)

Which requirements are in scope of which test phase


The Solution forReleases

Define required equipment folders, releases and cycles


The Concept for Test Planning


The description for the test plan

Which requirement are covered in the test plans

The purpose and requirement coverage on each test step

Review comments


The Solution for Test Planning


The Solution forTest Plan

Test case description field


The Solution forTest Plan

Usage of the comment feature


The Concept forTest Protocols


The textual description for protocols

Purpose of the protocols

Review comments

Approval level for the protocols

Which test phase the protocol belong to


The Solution forTest Protocols

Purpose & Description


Test Execution

Supports different execution schemes:

Qualification:

Requirements must be approved prior to test execution

Test Set must be approved prior to test execution

Test Cases must be approved prior to test execution

Commissioning:

Test Cases must be approved prior to test execution

Test Set must be approved prior to test execution

Interim:

No approvals or enforced workflow


The Concept forTest Reporting


The textual description for report

Purpose of the report

Review comments

Approval level for the report

Which Test protocols belongs to this report


The Solution for Test Reporting

Show review report feature


SolutionTest Report

186A Review Report.mht


SolutionTest Report


Equipment Status control

Equipment 186A Validation Status Report.xls


Supporting Documents & Organisation

User manuals

Local Standard Operation Procedures

Training Material

Super Users

Functional Support


Business benefits

The following have been achieved from the solution:

Requirements & related risks are stored together

Testing information are structured in one place

Communication and status during projects is much easier

now

Now it is easier to reuse of approved records

Much easier to maintain traceability in general

Started using the project execution time 24 hours around the

world

To obtain testing evidence is much easier – such as

attachments & screendumps

Much better control of equipment validation status

The other words …faster, cheaper, better overview


Any Questions?

Contact:

[email protected]

[email protected]

mailto:[email protected]

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