cmt – keeps your parameters under control - · pdf filethe question “why the...

For internal use only / © Siemens AG 2008. All rights reserved.

CMT –Keeps your parametersunder controlSiemens Compact Monitoring Technology keeps your GxP Environmental parametersunder control to release your products.

Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 2

CMTAgenda

GAMP 5

Life science Industry & CMT focus

CMT – 4 steps to complyStep 1:Define your GxP parametersStep 2:CMT, your technical solutionStep 3:CMT, a validated solutionStep 4:Services zur Pflege des validierten Zustandes


Saving Time and Money With GAMP 5?

GAMP 5 has been marketed as„... an excellent basis for streamlining validation efforts“Risk based approachScalable life cycleHolistic life cycle approach


GAMP5 Highlights

Nowadays, it is now enough to simply validate the system. The question “why the system have to be validated” must be also be answered

Risk assessments and Risk Management

Using the supplier as much as possible in the project

Split the BMS system into two: one for the HVAC and the second one using as a EMS (Environmental Monitoring System)


Initial risk assessment vs. functional risk assessment


Split the system into two

ETHERNET TCP/IPWindows Domain environment

PX modular

CMT DESIGO INSIGHTV2.35 Client

Fileserver W2003SDESIGO INSIGHT V2.35

Management Level

Automation Level

PX CompactPX modular

LON

PXM20-E

ETHERNET TCP/IP

Firewall


For whom?

Focus

Regulations FDA with 21 CFR 210, 211, EU with GMP Volume 4 & GAMP 5 require validation for all parameters affecting product quality

CMT – Its focus is to ensure Life Sciences industry’s product quality and people life safety

Ensure 100% quality by monitoring all critical parameters to protect & assure patients and consumers Health & Safety


CMT – Monitors your relevant environmental parameters

What are the segments from the life scienceindustry subjected by these laws?

Blood transfusion

PharmaceuticalProduction

Food & Beverage

Hospitals

Universities

Laboratories


CMT – 4 Steps how CMT complies with all 8 regulatory requirements?

Requirement Requirements Requirements Requirement

Define Your technical solution Validation Service

Step 1: Step 2: Step 3: Step 4:

Impact analysis und risk assess-ment

A validation solution

Maintain your validated status

Transform data into information, your trending and reporting

Backup und Archiving functions

Fast compiling functions and easy accessibility

IT security

Physical security

1 2 3 4 5 6 7 8

Four steps to CMT:


Administration, R&D, Production, Logistics

Step 1: Define your critical parametersMake the impact & risk assessment

Research & Development

Pre-clinicaltests Clinical tests Production Storage /

solutions

Support Functions

Datacenter

Office / Administraion

1. Make a IMPACT ANALYSISTo define which activities could have a critical impact on patient

2. Make a RISK ASSESSMENTDefine critical parameters which have a risk of damaging the product quality


Step 2: Your technical solution

Your unique solution to monitor your critical parameters, Compact Monitoring Technology (CMT)

… will be monitored by CMT

When the HVAC is considered as critical (in sterile environments) BACS & BMS have to be validated. Only Validating the EMS might not be sufficient.

All the defined criticalParameters

OnlyCMTto be

validatedNot to be validated

∆P∆P∆P∆P∆P∆P∆PTT

RHRH


Step 2: Your technical solution, to comply & keepyour data under control










IT security

Physical security

1 2 3 4 5 6 7 8

Four steps to CMT:


Step 2: You technical solution CMT, in few words “Keeps your parameters under control“

CMT is a solution which gathers, stores, organizes an darchives data and provides a range of analysis and reporting applications

A solution designed for the pharmaceutical industry

A future oriented solution, designed to grow

Getting a solution to meet the regulatory compliance and 21 CFR part11

CMT is a solution which is pre-installed, configured & tested

Install a tailor made solution for your needs


Step 2: Your technical solutionCMT, 7 key functionalities for your compliance

CMT – Monitors your relevant environmental parameters

5| CMT audit trail 6| Protect access with 7 levels of user access

7| Operate locally orremotely your CMT

1| Physical Security 2| Online Visualitzation 3| Archiving and Reporting

4| Warning & alarmingfuntcions


Step 2: Your technical solutionCMT physical security properties

Avoid unauthorizedacces to your criticaldata

Control & limit theaccess to your system.

Be sure noboy makeany sabotage on thesystem

Secured lock

No Problem

High or low warning

High or low alarms

Lighting alarms


Step 2: Your technical solution2, 3, 4 - CMT online, offline visualization & alarming

2. Online- visualizationPre configuerd pages for your parameters

Temperature, Humidity, Pressure, Binary in- and outputsPre configured Calibration pageOnline trending to see the evolution of your parameters

3. Reporting and long term archivingPre configured graphical reports to control the room conditionsLong term archiving(optional) Sign the reports electronically

4. Secure alarmingReceive an alarm if the CMT door is openPre-set high and low warning with orange lighting when limit is to be reachedPre-set high and low alarm with red lighting when limit are over passed


Step 2: Your technical solution5, 6, 7 - CMT online, offline visualization & alarming

5. Audit trailCe compliant with 21 CFR 11Track the system activities

Alarm, user, system, status

6. Protect acces7 user groups with related security acces rightsLimit the acces only to authorized users

7. OperationOperate CMT locally with the embedded “Touch Panel”Operate CMT locally with independent operation set (mouse, keyboard, screen)Remote reports operation with our “Report manager”Remote operation with Remote desktop functionalityRemote operation with the integration of CMT in your IT network


CMT – Compact Monitoring TechnologyOptions

More securityUninterrupted Power Supply (UPS)5 port manageable Ethernet switchAlarm routing in Pager, SMS and email

You

r tec

hnic

al s

olut

ion

Step

2:

More accessibility

More security, archive andIT security

Get more trending and reporting functionality

More AccessibilityIntegration configuration into IT networkRemote desktop accessTouch panelVideo remote extension for 150 meters operationAdditional printer on the network Additional users

More functionsRemote reporting with InfoCenter clientsAdditional customized reportsAdditional customized graphsAdditional parameters (more sensors)


Your CMT and its components


Step 3: CMT – all you need for validation










IT security

Physical security

1 2 3 4 5 6 7 8

Four steps to CMT:


Step 3: CMT – all you need for validationCMT – “Keep your parameters under control“

Nowadays, it is now enough to simply validate thesystem. The question “why the system have to be validated” must be also be answered

Siemens as SME (Subject Matter Expert) to leverage ist knowledge, experience and documentation

A solution based on Siemens risk based approach to protect your GxP parameters

Getting a solution to meet the regulatory compliance and 21 CFR part11

CMT is a solution which is documented with all live cycledocuments & pre-tested until FAT

CMT can be tested with additional on site test such as SAT, verification tests

Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 22Quelle: GAMP

Step 3: CMT – all you need for validationCMT – folow the recommendation of te GAMP 5‘s V-Model

Initial Risk Assessment

Functional Risk Assessment

User Testing of Controls and Procedures

Testing ofSystem Controls

User Requirements Specification

Functional Specification

Configuration Specification

ConfigurationTesting

FunctionalTesting

RequirementTesting

ConfiguredProduct

Iteration as required

GAMP 5IQ/OQ phase

reduced

GAMP 5Risk basedapproach

Siemens QMSCMT configurableproduct (CAT 3)


Step 3: CMT – all you need for validationWhat are CMT validation documents?

Time to Market risk minimizingCost reducing

Risk based approach

Pre tested, pre configured

Traceability

Documentation management

CMT!

URS

FSSDS

FATS

SATS

DesignReview

CMP

FAT

SAT

Verificationchecklist

TraditionalIQ/OQ


Step 3: CMT – all you need for validationWhat are CMT validation documents?

Standard documentsDesign documentation as pdf (URS, FS, SDS, FAT, traceability matrix)Configuration management plan (CMP)SAT documentsTechnical documents (Manual, wiring diagram, mounting instructions)Verification check list (traditional IQ/OQ) based on the standard installation8 SOPs (Backup, User Accounts, Recovery)

When you sell more than CMT standard, some changes are requiredYou need Word documents to edit them all in EVT!


Step 4: CMT – Services to maintain your validatedstatus










IT security

Physical security

1 2 3 4 5 6 7 8

Four steps to CMT:


Step 3: Maintain the validated status of your CMT

Dedicated Life Sciences services part of BT global services

The global BT advantage service The dedicated Life sciences servicesare part of 2 Advantages service groups


Step 3: Maintain the validated status of your CMT

3 groups of dedicated CMT Life science services


Do you haveany questions?


Thomas RiffelHead Center of Competence Life ScienceSiemens Schweiz AGBuilding Technologies I BT BAU MA VMLSGubelstrasse 22CH-6301 Zug

Tel. +41 724 52 74E-Mail: [email protected]

Contact Information

For internal use only / © Siemens AG 2008. All rights reserved.

cmt – keeps your parameters under control - · pdf filethe question “why the...

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