AB PROFESSIONAL SERVICES

The validation process required by FDA regulations—for fi rst-time validation or for system upgrades—can be complex, time consuming and costly. Our comprehensive Software Validation Service can signifi cantly ease this burden.

Analyst® Software Validation ServiceSave validation costs and time. Trust your software validation support to the company who designs your software.

understanding of your requirements helps make validation faster and more cost effective

• Project Management – Our project management methodology helps manage risk, control costs, and speed validation of your systems

What do you receive with our Analyst® Software Validation Service?While deliverables will vary depending on your exact needs, the deliverables that will be supplied for most projects include:

• Software Validation Plan

• Review SOPs

• Review of best practices for auditing and security

• User Requirements Specification

• Test Cases

• Deviation Reports (where applicable)

• Objective Evidence

• Traceability Matrix

• 21 CFR Part 11 Assessment

• Project Management Documents (including Project Planning, Issues Management, Risk Management, and Project Status artifacts)

Experienced Support for Regulatory ComplianceThe process of validating your lab systems can be very time-consuming and costly. Applied Biosystems’ Software Validation Service can help you comply with the changing regulations by easing complexity, managing risk, and reducing validation costs. Our professionals—working closely with you both off-site and in your lab—help you get into production faster and get the most out of your investment in our platforms.

Our Professional Service team is uniquely qualified to support your software validation requirements.

• Knowledge – We are unmatched in our understanding of Applied Biosystems’ software and instruments, and have in-depth knowledge of FDA 21 CFR Part 11 and GLP compliance requirements

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

• Speed – Our experience allows us to help you validate your systems quickly and efficiently

• Value – Our software and validation expertise combined with your in-depth

To validate your Analyst® Software or not. An exercise in risk management.

If your laboratory operates in a regulated environment, you may be required to validate

your software. The FDA and other agencies regulations pertaining to electronic records

and electronic signatures, 21 CFR Part 11 in combination with the predicate rules, requires

validation of electronic record-keeping systems to ensure their accuracy, reliability, and

consistent performance, as well as to ensure the system’s ability to identify altered or

invalid records.

Flexible Data Acquisition and Fast Data ProcessingAnalyst® Software is an integral component of Applied Biosystems/MDS SCIEX triple quadrupole and linear ion trap LC/MS/MS instrument systems. The software facilitates full system integration with auto-samplers, HPLC pumps, and ion sources, and serves as a single-point of control, making your work faster and more effi cient. The software also includes a comprehensive suite of features for building a 21 CFR Part 11 compliant environment including complete role-based security, auditing, and electronic records.

Comprehensive security and centralized audit trail features provide confi dence your electronic records are valid—for regulated laboratories that need to achieve GLP compliance. This commitment to providing the features you need is why more LC/MS-based 21 CFR Part 11 labs rely on Analyst®

Software than any other software in the industry.

Gather initial information

Assess software risk

Define high-level requirements

Generate test plan

Produce test cases Take corrective action

Record deviations

Execute test cases and record objective evidence

Create testing summary

Create traceability matrix

Review and accept validation

Plan for validation maintenance

Closure

Figure 1: Though the software validation process can be complex, time consuming and costly, Applied Biosystems can signifi cantly ease this burden through its comprehensive Software Validation Service.

“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 defi ning your requirements through to testing the

system is an investment that should be updated as the validated

application is enhanced.”

Bob McDowall PhD. C.Chem. FSRCPrincipal, McDowall Consulting

Headquarters850 Lincoln Centre Drive | Foster City, CA 94404 USAPhone 650.638.5800 | Toll Free 800.345.5224www.appliedbiosystems.com

International SalesFor our offi ce locations please call the divisionheadquarters or refer to our Web site atwww.appliedbiosystems.com/about/offi ces.cfm

For Research Use Only. Not for use in diagnostic procedures.

Applera, Applied Biosystems and AB (design) are registered trademarks of Applera Corporation or its subsidiaries in the US and/or certain other countries. Analyst is a registered trademark of Applied Biosystems/MDS SCIEX, a joint venture between Applera Corporation and MDS Inc.

© 2007 Applera Corporation and MDS Inc. All Rights Reserved. Information subject to change without notice.

Printed in the USA. 05/2007 Publication 138PB01-02.

For more information on Analyst® Software Validation Service, contact your local Applied Biosytems/MDS SCIEX Sales representative or e-mail softwarevalidation@appliedbiosystems.com

Commitment to QualityOur Professional Services team follows best practices set by Project Management Institute®’s Project Management Body of Knowledge (PMBOK). PMI has long been acknowledged as a pioneer in the project management fi eld and has a membership representing a global community of over 100,000 professionals from 125 countries.

Our commitment to this global standard of excellence means that you get not only our industry expertise and technical knowledge, but the highest level of quality in project management. To further ensure that you get superior services, our professional services organization adheres to the principles set by our global project management offi ce, which provides full project control and management support.

Following these best practices, we help ensure that we meet your timelines within prescribed standards, manage project constraints and budget, minimize costs, and maximize quality.

With this commitment to excellence and having designed and built your software, we are uniquly qualifi ed to support your software validation requirements.

The Right ChoiceNo one understands AB instruments and software better than the company than designed, built, and supports them. And no one has a longer history of integrating AB systems into complex laboratory environments. With our experience, expertise, and commitment to excellence, Applied Biosystems is the right choice for your Professional Services needs.

“I have been working with the AB Professional

Services Group to develop and deliver their

validation services for Analyst® since mid 2006.”

Bob McDowall PhD. C.Chem. FSRCPrincipal, McDowall Consulting