certificate of software validation

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OMNIC™ Software Suite Version 9.12 HF 6 Certificate of Software Validation This version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’s Madison, Wisconsin, development and manufacturing site and has been designed, tested and manufactured in accordance with that site’s ISO 9001 compliant Product Development Process. Development is monitored with business plan reviews, quality audits, technical reviews and complete system validation. Compliance of design elements to product, design and validation specifications is verified through a traceability matrix. The precision and accuracy of software code and algorithms are verified through an approved test plan, release candidate testing and documented test results. This ensures that you receive quality software products from Thermo Fisher Scientific Inc. Release Notes for the version are provided with the software. Jonathan Pundt Sr. Manager, Global Program Management Thermo Fisher Scientific Molecular and Microanalysis Products 5225 Verona Rd. Madison, WI 53711 269-344902 B Thermo Fisher Scientific www.thermofisher.com 5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

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Page 1: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.12 HF 6

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’sMadison, Wisconsin, development and manufacturing site and has been designed, tested andmanufactured in accordance with that site’s ISO 9001 compliant Product Development Process.

Development is monitored with business plan reviews, quality audits, technical reviews andcomplete system validation. Compliance of design elements to product, design and validationspecifications is verified through a traceability matrix. The precision and accuracy of softwarecode and algorithms are verified through an approved test plan, release candidate testing anddocumented test results. This ensures that you receive quality software products fromThermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Jonathan PundtSr. Manager, Global Program ManagementThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

269-344902 B

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

Page 2: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.12 HF 5

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’sMadison, Wisconsin, development and manufacturing site and has been designed, tested andmanufactured in accordance with that site’s ISO 9001 compliant Product Development Process.

Development is monitored with business plan reviews, quality audits, technical reviews andcomplete system validation. Compliance of design elements to product, design and validationspecifications is verified through a traceability matrix. The precision and accuracy of softwarecode and algorithms are verified through an approved test plan, release candidate testing anddocumented test results. This ensures that you receive quality software products fromThermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Jonathan PundtSr. Manager, Global Program ManagementThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

269-344901 F

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

Page 3: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.12 HF 4

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’sMadison, Wisconsin, development and manufacturing site and has been designed, tested andmanufactured in accordance with that site’s ISO 9001 compliant Product Development Process.

Development is monitored with business plan reviews, quality audits, technical reviews andcomplete system validation. Compliance of design elements to product, design and validationspecifications is verified through a traceability matrix. The precision and accuracy of softwarecode and algorithms are verified through an approved test plan, release candidate testing anddocumented test results. This ensures that you receive quality software products fromThermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Jonathan PundtSr. Manager, Global Program ManagementThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

269-344901 E

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

Page 4: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.12 HF 3

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’s Madison, Wisconsin, development and manufacturing site and has been designed, tested and manufactured in accordance with that site’s ISO 9001 compliant Product Development Process.

Development is monitored with business plan reviews, quality audits, technical reviews and complete system validation. Compliance of design elements to product, design and validation specifications is verified through a traceability matrix. The precision and accuracy of software code and algorithms are verified through an approved test plan, release candidate testing and documented test results. This ensures that you receive quality software products from Thermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Caroline DavisSr. Quality EngineerThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

269-344901 D

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

Page 5: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.12 HF 2

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’sMadison, Wisconsin, development and manufacturing site and has been designed, tested andmanufactured in accordance with that site’s ISO 9001 compliant Product DevelopmentProcess.

Development is monitored with business plan reviews, quality audits, technical reviews andcomplete system validation. Compliance of design elements to product, design and validationspecifications is verified through a traceability matrix. The precision and accuracy of softwarecode and algorithms are verified through an approved test plan, release candidate testing anddocumented test results. This ensures that you receive quality software products fromThermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Caroline DavisSr. Quality EngineerThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

269-344901 C

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

Page 6: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.12 HF 1

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’sMadison, Wisconsin, development and manufacturing site and has been designed, tested andmanufactured in accordance with that site’s ISO 9001 compliant Product DevelopmentProcess.

Development is monitored with business plan reviews, quality audits, technical reviews andcomplete system validation. Compliance of design elements to product, design and validationspecifications is verified through a traceability matrix. The precision and accuracy of softwarecode and algorithms are verified through an approved test plan, release candidate testing anddocumented test results. This ensures that you receive quality software products fromThermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Dr. Brit MeierSr. Director, Spectroscopy R&DThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

269-344901 B

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

Page 7: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.12

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’sMadison, Wisconsin, development and manufacturing site and has been designed, tested andmanufactured in accordance with that site’s ISO 9001 compliant Product DevelopmentProcess.

Development is monitored with business plan reviews, quality audits, technical reviews andcomplete system validation. Compliance of design elements to product, design and validationspecifications is verified through a traceability matrix. The precision and accuracy of softwarecode and algorithms are verified through an approved test plan, release candidate testing anddocumented test results. This ensures that you receive quality software products fromThermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Dr. Brit MeierSr. Director, Spectroscopy R&DThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

269-344901 A

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

Page 8: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.11 HF 7

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’sMadison, Wisconsin, development and manufacturing site and has been designed, tested andmanufactured in accordance with that site’s ISO 9001 compliant Product DevelopmentProcess.

Development is monitored with business plan reviews, quality audits, technical reviews andcomplete system validation. Compliance of design elements to product, design and validationspecifications is verified through a traceability matrix. The precision and accuracy of softwarecode and algorithms are verified through an approved test plan, release candidate testing anddocumented test results. This ensures that you receive quality software products fromThermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Dr. Brit MeierSr. Director, Spectroscopy R&DThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

269-344900 B

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

Page 9: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.11 HF 6

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’sMadison, Wisconsin, development and manufacturing site and has been designed, tested andmanufactured in accordance with that site’s ISO 9001 compliant Product DevelopmentProcess.

Development is monitored with business plan reviews, quality audits, technical reviews andcomplete system validation. Compliance of design elements to product, design and validationspecifications is verified through a traceability matrix. The precision and accuracy of softwarecode and algorithms are verified through an approved test plan, release candidate testing anddocumented test results. This ensures that you receive quality software products fromThermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Dr. Brit MeierSr. Director, Spectroscopy R&DThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

269-344900 A

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

Page 10: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.11 HF 5

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’sMadison, Wisconsin, development and manufacturing site and has been designed, tested andmanufactured in accordance with that site’s ISO 9001 compliant Product Development Process.

Development is monitored with business plan reviews, quality audits, technical reviews andcomplete system validation. Compliance of design elements to product, design and validationspecifications is verified through a traceability matrix. The precision and accuracy of softwarecode and algorithms are verified through an approved test plan, release candidate testing anddocumented test results. This ensures that you receive quality software products fromThermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Jonathan PundtSr. Manager, Global Program ManagementThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

Page 11: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.11 HF 4

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’sMadison, Wisconsin, development and manufacturing site and has been designed, tested andmanufactured in accordance with that site’s ISO 9001 compliant Product Development Process.

Development is monitored with business plan reviews, quality audits, technical reviews andcomplete system validation. Compliance of design elements to product, design and validationspecifications is verified through a traceability matrix. The precision and accuracy of softwarecode and algorithms are verified through an approved test plan, release candidate testing anddocumented test results. This ensures that you receive quality software products fromThermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Jonathan PundtSr. Manager, Global Program ManagementThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

Page 12: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.11 HF 3

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’sMadison, Wisconsin, development and manufacturing site and has been designed, tested andmanufactured in accordance with that site’s ISO 9001 compliant Product Development Process.

Development is monitored with business plan reviews, quality audits, technical reviews andcomplete system validation. Compliance of design elements to product, design and validationspecifications is verified through a traceability matrix. The precision and accuracy of softwarecode and algorithms are verified through an approved test plan, release candidate testing anddocumented test results. This ensures that you receive quality software products fromThermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Jonathan PundtSr. Manager, Global Program ManagementThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

Page 13: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.11 HF 2

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’sMadison, Wisconsin, development and manufacturing site and has been designed, tested andmanufactured in accordance with that site’s ISO 9001 compliant Product Development Process.

Development is monitored with business plan reviews, quality audits, technical reviews andcomplete system validation. Compliance of design elements to product, design and validationspecifications is verified through a traceability matrix. The precision and accuracy of softwarecode and algorithms are verified through an approved test plan, release candidate testing anddocumented test results. This ensures that you receive quality software products fromThermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Jonathan PundtSr. Manager, Global Program ManagementThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

Page 14: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.11 HF 1

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’sMadison, Wisconsin, development and manufacturing site and has been designed, tested andmanufactured in accordance with that site’s ISO 9001 compliant Product Development Process.

Development is monitored with business plan reviews, quality audits, technical reviews andcomplete system validation. Compliance of design elements to product, design and validationspecifications is verified through a traceability matrix. The precision and accuracy of softwarecode and algorithms are verified through an approved test plan, release candidate testing anddocumented test results. This ensures that you receive quality software products fromThermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Jonathan PundtSr. Manager, Global Program ManagementThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

Page 15: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.11

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’sMadison, Wisconsin, development and manufacturing site and has been designed, tested andmanufactured in accordance with that site’s ISO 9001 compliant Product Development Process.

Development is monitored with business plan reviews, quality audits, technical reviews andcomplete system validation. Compliance of design elements to product, design and validationspecifications is verified through a traceability matrix. The precision and accuracy of softwarecode and algorithms are verified through an approved test plan, release candidate testing anddocumented test results. This ensures that you receive quality software products fromThermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Jonathan PundtSr. Manager, Global Program ManagementThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

Page 16: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.9 HF 2

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’sMadison, Wisconsin, development and manufacturing site and has been designed, tested andmanufactured in accordance with that site’s ISO 9001 compliant Product Development Process.

Development is monitored with business plan reviews, quality audits, technical reviews andcomplete system validation. Compliance of design elements to product, design and validationspecifications is verified through a traceability matrix. The precision and accuracy of softwarecode and algorithms are verified through an approved test plan, release candidate testing anddocumented test results. This ensures that you receive quality software products fromThermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Jonathan PundtSr. Manager, Global Program ManagementThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

Page 17: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.9 HF 1

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’sMadison, Wisconsin, development and manufacturing site and has been designed, tested andmanufactured in accordance with that site’s ISO 9001 compliant Product Development Process.

Development is monitored with business plan reviews, quality audits, technical reviews andcomplete system validation. Compliance of design elements to product, design and validationspecifications is verified through a traceability matrix. The precision and accuracy of softwarecode and algorithms are verified through an approved test plan, release candidate testing anddocumented test results. This ensures that you receive quality software products fromThermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Jonathan PundtSr. Manager, Global Program ManagementThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100

Page 18: Certificate of Software Validation

OMNIC™ Software SuiteVersion 9.9

Certificate of Software ValidationThis version of OMNIC™ Software Suite software was developed by Thermo Fisher Scientific’sMadison, Wisconsin, development and manufacturing site and has been designed, tested andmanufactured in accordance with that site’s ISO 9001 compliant Product Development Process.

Development is monitored with business plan reviews, quality audits, technical reviews andcomplete system validation. Compliance of design elements to product, design and validationspecifications is verified through a traceability matrix. The precision and accuracy of softwarecode and algorithms are verified through an approved test plan, release candidate testing anddocumented test results. This ensures that you receive quality software products fromThermo Fisher Scientific Inc.

Release Notes for the version are provided with the software.

Jonathan PundtSr. Manager, Global Program ManagementThermo Fisher ScientificMolecular and Microanalysis Products5225 Verona Rd.Madison, WI 53711

Thermo Fisher Scientific www.thermofisher.com5225 Verona Rd. Madison WI, 53711 U.S.A. (608) 276-6100