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
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 3
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
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 4
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)
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 5
Initial risk assessment vs. functional risk assessment
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 6
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
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 7
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
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 8
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
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 9
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:
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 10
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
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 11
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
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 12
Step 2: Your technical solution, to comply & keepyour data under control
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:
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 13
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
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 14
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
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 15
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
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 16
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
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 17
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
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 18
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)
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 20
Step 3: CMT – all you need for validation
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:
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 21
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)
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 23
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
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 24
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!
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 25
Step 4: CMT – Services to maintain your validatedstatus
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:
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 26
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
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 27
Step 3: Maintain the validated status of your CMT
3 groups of dedicated CMT Life science services
Building Technologies / CoC PharmaJune 17, 2009 CoC Pharmapage 29
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.