1. Thermo FT-IR and Raman Spectrometer Compliance Products
PSE Group

2. What I will explain today…
What is the market for “compliance”?
What does “compliance” mean to a customer?
Who will pay for it and why?
What are Thermo’s “compliance products”?
And, how do customers benefit by buying them?
What is the role of the Service Engineer in “compliance”?
How does the Service Engineer become certified?

3. What is the market for “compliance”?

4. What does “Compliance” mean to a Customer?
Pharma companies need to comply with regulations
Non-pharma companies are moving this way as well
Implementing and maintaining “validated” processes is expensive
Customers want instrument vendors to help reduce:
Amount of time spent qualifying an instrument
Use of internal personnel to perform qualification tasks
Risk of having an audit finding from regulators

5. Why will Customers Pay Us for “Compliance”?
Regulations or expected quality processes
Their company/industry rules and regulations dictate their level of “compliance”
It is too costly for customers to do it themselves
Lack of internal technical knowledge, expensive consultants
Save time commissioning the system
Can be put into operational faster, time vs. cost trade off
Reduced regulatory exposure
Using the documentation and certification from the vendor is considered more reliable to auditors

6. How Thermo Vibrational Spectroscopy Products Address Regulatory Requirements
System Qualification
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
Operator Training
Data Security & Integrity
Operator Access Control
Data Integrity & Retention
System & Data Audit Trails
Operational Procedures
Thermo Validation Products
ISO-9001 certified Product Development Process
Val-Pro & IQ/OQ Services and Certification
Thermo Multi-Vendor Compliance Services
Customer Training Courses
Thermo Security Tools
OMNIC DS and Thermo Security Administration

7. What are Thermo’s “compliance products”?

8. Laboratory FT-IR & Raman Compliance Offerings
ValPro System Qualification Packages
Software
Extensive documentation
Certified standards
OMNIC DS & Thermo Security Administration Software
Data security and audit trail
21 CFR Part 11 compliance tools
Thermo Certification Services
Installation Certification
Installation Re-Certification
Annual Re-Certification
OMNIC DS OQ
Relocation
Operator Training Courses
Sample handling
Data Interpretation

9. ValPro System Qualification
What is it?
Tools that test and document the system is performing to factory specifications and continues to perform
Who buys it?
Required for pharmaceutical companies due to regulations
Not just at QA/QC level – but pushing upstream to R&D
Suppliers to pharmaceutical companies starting to self-regulate
Like Thermo, they want to win business with key pharma accounts
Anyone doing QA/QC (industrial, manufacturing, etc.)
Any company that is ISO 9001 Certified is a target
How the customer benefits
Increased confidence in results
Decrease time/cost to commission a new system or re-qualify an existing system when required by regulations

10. ValPro System Qualification for FT-IR & Raman
ValPro System Qualification Binder
Four packages:
Nicolet 380 and X700 Series
Nicolet NXR 9600 FT-Raman
Nicolet Almega Dispersive Raman
Nicolet Legacy FT-IR
(Avatar, Nexus, Magna, IR300)
ValPro System Qualification CD
ValPro Qualification Software
Qualification Test scripts
Documents CD
Includes all documents from binder in PDF format
Standards must be ordered separately
Smart Accessories and Raman modules are qualified as part of the Nicolet Series or legacy FT-IR packages
OMNIC 7.2 or above required
There are four ValPro system qualification packages available customized for different spectrometer products. These include packages for:
Nicolet Series FT-IR systems which include the Nicolet 380 and X700
Nicolet NXR 9600 FT-Raman
Nicolet Almega Dispersive Raman
Nicolet legacy FT-IR systems which include Avatar, Nexus, Magna, IR300 & Genesis II
Each package includes a ValPro System Qualification binder which has specific IQ, OQ and RQ procedures for these instruments
Each binder includes the ValPro Qualification software with qualification test scripts. Also included is a documents CD with all the binder documents and reference documents in PDF format.
All standards for running ValPro qualification tests must be purchased separately.
Smart Accessories and the Raman module are treated as accessories to the main FT-IR system and qualified as part of the ValPro for Nicolet series or legacy packages.
The minimum OMNIC software requirement for running ValPro software is version 7.2.

11. ValPro System Qualification for FT-IR & Raman
Traceable Standards
Tested using Thermo’s factory traceability process
Each standard traced to a primary standard
Includes standards for legacy systems
Complete documentation
Traceability certificate
Test results
Manual explaining process
Installation Certification Services
Includes factory data traceability
IQ and OQ Procedure Execution
DS OQ Service is still separate
Services not required, but….
No factory traceability link established
Customer assumes risk
Relocation & Re-certification services also available
In addition to the ValPro packages Thermo offers services which provide factory traceability for the instruments and offer third-party certification of their installation. Installation certification includes factory test data and execution of the IQ & OQ procedures. The OMNIC DS software OQ service is still a separate service that is available for those for those requiring the detailed software operational qualification of OMNIC’s 21 CFR Part 11 features.
Installation certification is not required for use with ValPro, but if it is not purchased no factory traceability of the instrument is established, and the customer assumes the regulatory risk for the system qualification.
Re-certification services are also available to assist the customer in maintaining their system in a qualified state.
Legacy spectrometers can update to ValPro or stay with Val-Q if it is already in use. In either case, the qualification standards now use our new traceability process.

12. ValPro for Nicolet Series FT-IR (834-044100)
Systems:
Nicolet 380 & X700 Series
Method:
ASTM E1421: Energy Ratio & Noise
European Pharmacopeia: Wavelength Accuracy & Resolution
Japanese Pharmacopeia: Repeatability
NPL NG11 Schott Glass Detector linearity
Standards:
NIST-traceable 1.5 mil Polystyrene
NPL-traceable NG11 Schott Glass
Card sets or wheels
ValPro Nicolet Series FT-IR System Qualification includes the Nicolet 380 and X700 series spectrometers.
Thermo has adopted methods and standards from internationally recognized bodies including ASTM, NIST, NPL, and the European and Japanese Pharmacopeia. The Pharmacopeia methods were chosen because they contain published and accepted pass/fail limits. If limits are not published, they are established by Thermo based on sound statistical practice.
The qualification test for the Nicolet Series FT-IR’s inlcude ASTM E Energy Ratio and Noise tests, EP wavelength accuracy and resolution tests, JP wavelength and intensity repeatability tests, and a detector linearity test based on the NPL NG11 glass standard.
Traceable standards used for the Nicolet Series qualification test include NIST-traceable 1.5 mil polystyrene and NPL-traceable NG11 Schott glass. These standard come in two forms – card sets for manual operation and standards wheels for automated operation. NPL-calibrated polystyrene cards are also available for manual operation only.

13. ValPro for Smart Accessories
Systems:
Smart Orbit, Smart Performer, Smart Diffuse
Nicolet 380, X700 Series, Avatar, Nexus
Qualified as accessory to Nicolet Series or Legacy FT-IR in ValPro
Method:
European Pharmacopeia: Wavelength Accuracy
Full Width at Half Height Resolution
Standards:
ATR uses a NIST-traceable Polystyrene Wand
MIR Diffuse uses a NIST-traceable Polystyrene Slide
Smart Accessories are handled as part of the main FT-IR system qualification. Accessories that are included are the Smart Orbit with Diamond crystal, Smart Performer with ZnSe crystal, and Smart Diffuse. The FT-IR systems that can use these Smart Accessories include the Nicolet 380, X700, Avatar, and Nexus systems.

14. ValPro for FT-Raman (834-044200 – NXR 9600*)
Systems:
NXR 9600 or FT-Raman Module
Requires 180 degree reflective accessory
*FT-Raman module qualified as accessory in Nicolet Series or Legacy FT-IR ValPro
Method:
ASTM E1840 Wavelength Accuracy
Noise
Relative response
Standard:
Traceable Proprietary Polystyrene Macro Sampling Standard

15. ValPro for Dispersive Raman (834-044300)
Systems:
Almega XR, Almega
Method:
ASTM E1840 Wavelength Accuracy
Noise
Relative response
Standard:
Traceable Proprietary Polystyrene Micro Sampling Standard

16. ValPro for Legacy FT-IR (834-044000)
Systems:
Nexus, Avatar, Magna, Protégé, IR300, Genesis 2
Methods – either existing ASTM or EP Legacy:
ASTM E1421: Energy Ratio & Noise
ASTM or European Pharmacopeia: Wavelength Accuracy & Resolution
3.0 mil Photometric Accuracy
Standards:
NIST-traceable 1.5 mil Polystyrene
Traceable proprietary 3.0 mil Polystyrene
Card sets or wheels
Legacy systems can update to ValPro or stay with Val-Q (if they already own Val-Q)
In either case, the standards follow new traceability process

17. Why ValPro? Val-Q was outdated in documentation & flexibility
No longer met customers expectations for a qualification package
Could only run one method which did not meet the needs of all of our customers
ValPro addressed these issues by providing
A “professional” qualification package
Ability to run a variety of performance verification methods
Flexibility to add new methods
Thermo Security Administration compatibility for 21 CFR Part 11 compliance
ValPro provides a consistent level of quality across all products (NIR, FTIR, Raman)
And, for the average operator ValPro is as simple to run as Val-Q

18. OMNIC DS & Thermo Security Administration Software
What is it?
Security control software: safeguards data files, maintains audit trails, controls access to system, and controls access to specific software functions
Allows a single set of IT policies to cover all Thermo molecular spectroscopy instruments on a network (local or global)
Who buys it?
Required for pharmaceutical companies due to regulations
Not just at QA/QC level – but pushing upstream to R&D
Suppliers to pharmaceutical companies starting to self-regulate
Anyone with internal data security policies.
How the customer benefits
Decreased chance of “operator error” affecting data integrity
Can enforce following SOPs
Required for 21 CFR 11 and Annex 11 compliance (operator authentication and accountability)
Centrally manage security policies for all Thermo instruments

19. Thermo System Certification Services
What is it?
Thermo certifies that the system is performing to factory specifications when it is initially installed at the customer’s site, if the instrument is relocated or on an ongoing basis as determined by the customer’s internal procedures
Who buys it?
Required for pharmaceutical companies due to regulations
Not just at QA/QC level – but pushing upstream to R&D
Suppliers to pharmaceutical companies starting to self-regulate
Like Thermo, they want to win business with key pharma accounts
Anyone doing QA/QC (industrial, manufacturing, etc.)
Any company that is ISO 9001 Certified is a target
How the customer benefits
Additional confidence in results
Third- party certification may be more desirable to regulators
Decrease time/cost to commission a new instrument

20. System and Software Operation Training Courses
What is it?
Training in proper use and care of the system for method developers and end-user operators.
Who buys it?
Pharmaceutical companies and their suppliers due to regulatory requirements
Anyone relatively new to FT-IR and Raman that buys an instrument
Customers switching to Thermo from competitor systems
How the customer benefits
Decreased chance of “operator error” affecting results
Some regulations (cGMP, 21 CFR 11, Annex 11) require evidence that operators are properly trained

21. Madison Site ISO 9001 Certified Quality System
Highly regulated customers need assurance that the products they buy are properly designed, tested and manufactured
Customers with serious compliance requirements will want to audit us
Reduces their risk exposure
We have successfully answered 100’s of questionnaires and had 10’s of audits
Auditing is time consuming and expensive for customers
Successful audits can lead to repeat sales from different labs and sites in the same company

22. What is the role of Service Engineer in “Compliance”?

23. “Compliance Certified” Field Service Engineers
Customers that purchase Installation Certification Services demand that the installer is properly trained and certified
Vendor is the primary system expert
Strong belief that IQ/OQ can be done better/faster/cheaper this way than doing it themselves
“Third party” certification is more acceptable to auditors
FSE must be certified on all products to be installed
Spectrometer
Software
Compliance products

24. “Compliance Products” that Require Certification
ValPro Software Installation & Operation
FT-IR
Nicolet Series (380 & X700)
Legacy Instruments (Avatar, Nexus, Magna, Genesis II)
Smart Accessories
Dispersive Raman
Almega
FT-Raman
All FT-Raman modules
NXR 9600
OMNIC DS Software Installation & Operation
Includes Windows Administrative tools

25. Basic Steps to ValPro Certification
Get factory trained on installation and operation of the systems; Nicolet 380, X700, NXR FT-Raman, Almega XR and Legacy
Learn the ValPro qualification process & terminology
Know the pre-installation requirements for each product
Understand the instrument installation procedures
Know the software installation procedures
Understand the ValPro IQ and OQ procedures
documentation requirements
how they relate to installation and training
Understand the use of standards & importance of Thermo traceability process
Know the contents and how to run the qualification methods and troubleshooting if failures occur.
Understand how ValPro interacts with OMNIC DS & Thermo Security Administration
Take the ValPro certification exam for the required product group

26. Basic Steps to OMNIC DS Certification
Become familiar with Windows software Administrative tools
Obtains a basic understanding of how OMNIC DS and Thermo Security Administration address the 21 CFR Part 11 regulations
Review the OMNIC DS and Thermo Security Administration documentation
Fully understand the Getting Started with OMNIC DS procedures
Understand how OMNIC DS and Thermo Security Administration interact with OMNIC software
Complete the OMNIC DS OQ procedure and exam