On-Site Computer System Validation ServiceReduce validation time and control costs. Trust your computerized system validation to the company that designs and supports your system.

COMPLIANCESERVICES

Storing electronic records? If so, you are using electronic records and may need to validate your system.

To validate your Applied Biosystems computer system or not: an exercise in risk management.If your laboratory operates in a regulated environment, you may be required to validate your computerized system. An instrument qualification (IQ/OQ) is only the starting point toward your validation. Global standards (e.g., GLP, GCP, GMP, ISO 17025, ISO 15189) and country-specific regulations (e.g., US FDA 21 CFR Part 11, CLIA, CAP) require validation of electronic record-keeping systems to ensure their accuracy, reliability, and consistent performance, as well as to ensure each system’s ability to identify altered or invalid records. Our on-site validation services can help you meet these requirements and reduce your compliance risk.

Experienced Support for Regulatory ComplianceWhether you have limited in-house expertise or you simply want a fixed-price plan to meet your regulatory requirements, Life Technologies Compliance Services can help you. Our professionals—working closely with your staff—can help you get into production faster, while controlling validation costs and managing your compliance risk.

Our compliance team is uniquely qualified to support your computer and laboratory information system validation requirements.

• KnowledgeandExperience—No one knows Applied Biosystems instruments or software better than the company that designs, builds, and supports them. And no one has a longer history of testing and validating our systems in complex laboratory environments.

• CostControl—Our on-site services deliver the support you need to meet your validation requirements at a predictable price. Once you choose your level of service, you will know exactly what the validation will cost. There are no hidden fees or variable costs.

• CurrentRegulatoryBestPractices—We constantly update our body of industry “best practices” and keep abreast of regulations

so we can help you comply with complex and changing global regulatory requirements.

• ReducedValidationTime—Our experience allows us to help you validate your systems quickly and efficiently, reducing laboratory start-up time or downtime.

• ProjectManagement—Our project management methodology helps manage risk, control costs, and speed validation of your systems.

What do you receive with our Computer System Validation Service?On-Site Standard Validation provides you with standard computer system validation performed on site by Life Technologies’ certified representatives. The service provides on-site testing and validation of typical system requirements for regulatory compliance, including:

• Comprehensive Computer System Validation user requirements and associated test cases to ensure electronic records are generated, maintained, and archived in an accurate, reliable, and secure manner

• Expedited delivery—beginning within two weeks of your final document approval

“Validation of computerized systems is essential from a business and regulatory perspective as it provides investment protection and demonstrates that a system meets its intended purpose. The process from defining your requirements through to testing the system is an investment that should be updated as the validated application is enhanced.”

BobMcDowall,PhD,CChem,FRSCPrincipal, McDowall Consulting

Supported SoftwareComputer System Validation is available for the following Applied Biosystems software packages:

• SDS Enterprise Edition 2.x Software for 7900HT Fast Real-Time PCR Systems

• SDS v1.4 21 CFR Part 11 Module Software for 7500 and 7500 Fast Real-Time PCR Systems

• SDS v1.5 21 CFR Part 11 Module Software for 7500 Fast Real-Time Systems

• ViiA™ 7 Real-Time PCR System v1.x Software• MDC v1.x Software for 3500xl Genetic Analyzer

Features• Multi-day, full-service delivery by experienced and trained

professionals• Library of traceable documents, test cases, support evidence,

and final report to record your computer system validation documentation

• Supports global regulatory compliance requirements (e.g., GxP and US 21 CFR Part 11 and ISO 17025, ISO 15189) and many local guidances

• Specifications defined to test high-risk system functions according to GAMP5 and to assess compliance to 21 CFR Part 11

Deliverables• Validation Plan• Risk Assessment for the system• User Requirements Specification (URS)• System Configuration Specification• Test Plan• Installation Qualification (IQ) testing and results• Operation Qualification (OQ) testing and results• Performance Qualification (PQ) testing and results• (Optional) Assessment for Compliance with Regulations Pertaining

to Electronic Records and Signatures (e.g., 21 CFR Part 11)• Validation Traceability Matrix• Quality Assurance Review• Validation Summary Report• Review of SOPs• Technical Support

Prerequisites• Recently qualified or requalified instrument(s)• Standard Operating Procedures as related to the lab system

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ORDERING INFORMATION

Description Part Number

7900HT Real-Time PCR System, Enterprise Computer System Validation Service CON00035

ViiA™ 7 Real-Time PCR System, Computer System Validation Service CON00045

7500 and 7500 Fast Real-Time PCR Systems, Computer System Validation Service CON00046

3500 Computer System Validation CON00036

Flexible Data Acquisition and Fast Data ProcessingIf you are printing, approving, and storing paper documents, and maintaining your electronic records, the regulations require you to validate the integrity of your electronic records.

Life Technologies offers software versions that can help you demonstrate compliance to regulations such as 21 CFR Part 11, ISO 15189, and ISO 17025. In order to validate your computerized laboratory system in accordance with regulations, it is necessary to place controls in the system. Controls can be of two types: procedural and technical. Procedural controls are processes that are documented, approved, and enforced typically through Standard Operating Procedures (SOPs). Technical controls are enforced through hardware and software. They reduce human effort through automation, thereby reducing the incidence of human error. Life Technologies offers dedicated software packages to help you control Security and Access, and to implement use of Electronic Signatures.

Not all software packages are created equal. Contact your local sales representative if you are unsure about your software package.

The Right Choice for Your Validation ServicesNo one understands Applied Biosystems instruments and software better than the company that designs, builds, and supports them. And no one has a longer history of integrating Applied Biosystems instruments into complex laboratory environments. Whether you choose on-site validation or another option within our portfolio of compliance services, Life Technologies is the right choice to help reduce your validation time, control your validation cost, and reduce your compliance risk.

Flexible Pricing PlansTo help you control validation costs, we offer cost savings on multi-system engagements for on-site validation.

If you require further customization for your validation process, or a broader scope of validation services, please contact us for more information on our Professional Services.

An Externally Reviewed Validation ApproachRobert McDowall, PhD, CChem, FRSC, a recognized authority in validation of laboratory data systems, worked with us to develop a comprehensive approach that would help meet global regulatory requirements when validating our software and systems.

For more information on our Computer System Validation Services, contact your local Applied Biosystems sales or service representative, or email complianceservices@lifetech.com