Analytical Instrument Qualification (Varian)

Varian, Inc.
Analytical Instrument
Qualification
Overview
8510228900
Issue 3
February 2008
Varian, Inc. Analytical Instrument Qualification Overview
Varian, Inc. – Serving Industries Worldwide

Biosciences
Pharmaceuticals
Clinical Research and Forensics
Food and Agriculture
Chemical Analysis
Environmental
Fuels and Energy
Material Sciences
Sales and Service Contact Details

North America: 800.926.3000, 925.939.2400
Europe, The Netherlands: 31.118.67.1000
Asia Pacific, Australia: 613.9560.7133
Latin America, Brazil: 55.11.3238.0400
Varian, Inc. Web Site

www.varianinc.com
Varian, Inc. is the owner of copyright on this document and any

associated software. Under law, the written permission of Varian
Inc must be obtained before either the documentation or the
software is copied, reproduced, translated or converted to
electronic or other machine-readable form, in whole, or in part.
First published December 2005. Updated in February 2008.
Factor Four, Inspiring Excellence, Varian and the Varian logo are
trademarks or registered trademarks of Varian, Inc. in the US and
other countries.
© 2005-2008 Varian, Inc.
Page 2 of 36 Publication no. 8510228900, Issue 3, February 2008

Contents
Varian, Inc. Industry Awards ........................................................ 5

Preface - Varian, Inc. ..................................................................... 7
Introduction to Varian, Inc. 7
History of Varian, Inc. 8
Real World Applications 9
Financial Status 10
Document Overview ................................................................... 11
1. Quality Systems at Varian, Inc. ......................................... 13
1.1 Quality Management System 13
1.2 Auditing Procedures 14
1.3 Employee Qualifications and Training 14
2. Regulatory Compliance and Analytical Instrument
Qualification ................................................................................ 15
2.1 Good Laboratory Practice 15
2.2 Current Good Manufacturing Practice 16
2.3 Analytical Instrument Qualification 16
2.4 When is AIQ Required? 17
2.5 FDA 21 CFR Part 11 Electronic Signatures and Records 18
2.6 Design Qualification 19
2.7 Installation Qualification 20
2.8 Operational Qualification 21
2.9 Performance Qualification 21
2.10 Preventative Maintenance and Re-qualification 22
3. Analytical Instrument Qualification at Varian, Inc............ 23
3.1 Development of Varian, Inc. Instruments 23
3.2 Development of the Varian, Inc. Software 25
Publication no. 8510228900, Issue 3, February 2008 Page 3 of 36

3.3 Pre-installation 27
3.4 IQ Documentation Provided by Varian, Inc. 27
3.5 OQ Documentation Provided by Varian, Inc. 28
3.6 Re-qualification 29
3.7 AIQ Package Provided by Varian, Inc. 30
3.8 Summary of Purchase and Qualification Procedures with
Varian, Inc. 31
3.9 Regulatory Compliance 32
4. Customer Support ............................................................... 33
4.1 Global Sales and Support 33
4.2 Varian Customer Training Courses 34
4.3 Support Agreements 34
4.4 Consumables and Spare Parts 35
4.5 Instrument Installation Procedure 35

Varian, Inc. Industry Awards
Varian, Inc. Awards:

2004 Varian, Inc. is named Analytical Instrumentation
Company of the Year by Frost and Sullivan –
Excellence in Industrial Technology Awards
2002 Business Week rank Varian, Inc. among the Nation’s
top growth companies
2002 Scientific Computing and Instrumentation Magazine
voted Varian UV spectrophotometers the best in
quality, reliability and value
2001 AusIndustry – Certificate of Achievement ICP Project
(Development of next generation ICP spectrometers)
1999-2000 Applied Biosystems recognizes Varian Vacuum
Technologies with the Outstanding Supplier Award
1999 Australian Institute of Engineers - Engineering
Excellence Award for Vista ICP Instrument
1998–1999 Vankel Technology Group Recognition Award –
Partnerships – Cooperation and support in the
advancement of Dissolution Automation “Total
Solution”
1998 Industrial Research 100 Award – Cary 50 UV-Vis
Spectrophotometer
1998 Silver Award – Strategic Industrial Research
International (Instrument Business Outlook) –
Excellence in Industrial Design – Cary 50
Spectrophotometer
1997 Industrial Research 100 Award - SuperProton Probe
1997 Australian Institute of Engineers - Engineering
Excellence Award for the Cary 50 and SpectrAA
220FS
1997 Vacuum Products – Massachusetts Quality Award
1997 Industry Week Magazine – names the Lexington MA
site as one of America’s best plants
1994 Industry Week magazine names NMR among the Top
10 List in its America’s Best Plants competition

1994 Australian Institute of Engineers – Highly Commended

- Engineering Excellence Award for UltraMass ICP
Mass Spectrometer
1991 Stockholm, Sweden – Richard Ernst Awarded the
Nobel Prize in Chemistry (Varian, Inc. employee from
1963–1968) He and Wes Anderson developed Fourier
Transform NMR – the Discovery that made Magnetic
Resonance Imaging practical
1987 Industrial Research 100 Award - VXR wide line solids
accessory
1986 Varian Australia wins Australian Export Award
1984 Industrial Research 100 Award - NMR spectrometer
XL series data system
1983 Australian Institute of Engineers (Victorian Branch) -
Engineering Excellence Award for the GTA-95
1977 Industrial Research 100 Award for SuperScan 3 UV-
Vis Spectrophotometer
1975 Industrial Research 100 Award - Model EM-390 NMR
spectrometer
1973 Industrial Research -100 Award for the PortaTestTM
Leak Detector
1971 Industrial Research 100 Award - Model EM-300 NMR
spectrometer
1971 Industrial Research 100 Award for Model 61 Carbon
Rod Atomizer
1970 Industrial Research 100 Award - XL-100 NMR
spectrometer
1967 Industrial Research 100 Award for AR-200 Atomic
Absorption Spectrophotometer
1966 Industrial Research 100 Award for AA-4 Atomic
Absorption Spectrophotometer
1964 Industrial Research 100 Award - NMR system model
HRSC-1
1963 Industrial Research 100 Award - Industrial Research
superconducting Magnet to achieve 65,000 Gauss

Preface - Varian, Inc.
Introduction to Varian, Inc.
Inspiring Excellence™ is at the Heart of Our Business.
Varian, Inc. is a diversified, global technology leader helping

customers innovate with confidence, enhance their
competitiveness, and boost their efficiency.
The headquarters of Varian, Inc. are in Palo Alto, California. Varian,
Inc. manufactures in twelve locations throughout North America,
Europe and the Pacific Rim and has sales and service offices
worldwide. It is a major supplier of analytical instrument solutions,
NMR systems, vacuum products, and associated services.
Our businesses — Scientific Instruments and Vacuum
Technologies — bring together high quality, innovative and user-
friendly products with industry-leading service and support to create
genuinely inspired solutions. Each person at Varian, Inc. is
dedicated to our credo — Inspiring Excellence™. This calls on us
to always act with integrity and with absolute commitment to our
customer’s needs and dreams. At Varian, Inc. we are inspired by
our customers and strive to inspire others in all we do.
Our people, products and solutions enable customers to meet
increasingly complex challenges in life sciences and industry.
Varian, Inc. provides leading edge tools and solutions for diverse,
high growth applications in life science and industry.

History of Varian, Inc.

The roots of Varian date back to 1948 when two brothers, Russell
and Sigurd Varian, put their heads together to start their own
company. Russ was a Stanford University graduate and inventor,
and Sig was a Pan American Airlines pilot. Their innovation and
enterprise built one of the primary companies in Silicon Valley,
Varian Associates. Russ’ invention, the klystron tube, which helped
make airborne radar possible before World War II, was the
company's first product. For the next fifty years Varian Associates
grew, renowned for its innovation. By 1999, the three primary
business segments had grown enough to become independent
organizations. Varian Associates split into three separate
companies: Varian Semiconductor, Varian Medical Systems, and
Varian, Inc., all retaining a name with a great legacy.
Today, backed by our global team of product and applications
experts, Varian is ideally suited to meet the mounting analytical
challenges in these and other scientific communities:
• Biosciences
• Pharmaceuticals
• Clinical Research and Forensics
• Food and Agriculture
• Chemical Analysis
• Environmental Analysis
• Fuels and Energy
• Material Sciences

Real World Applications

The following examples provide an overview of the diversity of
Varian instruments and technologies when applied to daily life.
• Varian Australia Pty Ltd has met our customer’s needs by
providing the world’s first fully-functional LC/MS equipped
mobile pre-race testing laboratory. This enables the track-side
drug testing of racing animals at horse racing events.
• ICP-MS technology is used to test the purity of our drinking
water. This includes testing for trace elements as recorded on
the labels of bottled water.
• Pharmaceutical companies worldwide rely upon Varian
equipment to continuously monitor and critical quality control
processes. In particular, for tablet testing and dissolution
testing.
• The FactorFourTM GC capillary column product lines are used
to test for trace analysis of volatile and semi-volatile
compounds for selected US Environmental Protection Agency
(EPA) and US Pharmacopoeia (USP) methods.
• Environmental laboratories world-wide use both Varian LC/MS
and GC/MS to test for pesticides and toxins in agricultural
products, keeping the food supply safe.
• Varian’s NMR systems are used world-wide in imaging
applications for oncology, cardiology, angiography and drug
effect studies.
• Varian HPLC columns are used in a broad range of industries

including pharmaceutical, environmental and food testing.
Applications include, quality control of pharmaceutical
products using USP methods; analysis of clinical samples for
diagnostic and metabolism studies, analysis of soil and water
according to EPA methods and the quality control of food.
• Varian Micro GC technology has become one of the most
important techniques to monitor energy -the calorific value- of
Natural Gas. Energy metering is used for billing of natural gas
consumption of households and industry and the optimization
of turbines in gas-electric power plants.

Financial Status
For the fiscal year ending September 2006, Varian, Inc. had sales
of $921 million. Overall, company expenditure on R&D was $65
million, accounting for 7% of revenue.
Varian, Inc. fiscal 2007 revenue grew by 10.7% over fiscal year
2006. A strong mix of new products, from both internal
development and complementary acquisitions, as well as our global
presence, helped fuel this growth. The Company is in an
advantageous position and is headed into fiscal 2008 with an
increased backlog for both the Scientific Instrument and Vacuum
Technologies segments.
Varian, Inc. is listed on NASDAQ as VARI Common Stock.
Additional financial information about Varian is available on the
Varian, Inc. Web site: www.varianinc.com

Document Overview
This document provides an outline of the commitment to Quality at

Varian, Inc., through its Quality Management System (QMS). It:
• Provides an overview of the Quality Management Systems at
Varian, Inc.
• Introduces the concept of Analytical Instrument Qualification
and relates it to regulatory compliance and quality assurance.
• Breaks down the qualification process into defined activities
and clarifies the vendors’ and customers’ roles, expectations,
and responsibilities for each.
• Explains Varian, Inc.’s approach to the Qualification process.
• Clarifies the scope of the Analytical Instrument Qualification
Packages provided by Varian, Inc.
• Provides an overview of Services and Customer support
provided by Varian, Inc.
• Provides clear, concise responses to a series of Frequently
Asked Questions, as well as references to relevant publications
from Varian, Inc.

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1. Quality Systems at
Varian, Inc.
This chapter provides an overview of the structure of the quality systems at Varian, Inc.
1.1 Quality Management System

At Varian, Inc., we are guided by several principles that define what
we do and how we do it.
Each of the Varian, Inc. manufacturing sites are ISO9001:2000
certified. Visit the following www.varianinc.com website to view the
certificates:
http://www.varianinc.com/products/iso/index.htm
Our Quality Policy states:
‘Varian, Inc. and its people are committed to meeting or exceeding

customer requirements for high-quality, competitive products,
services and solutions to their most pressing technical and process
challenges.
We will achieve this by focusing on continuous improvement in
everything we do, listening to our customers, and responding to
them with dedication and innovation.’
The Quality Management System (QMS) is supported by

department procedures including Policies, Processes, Standard
Operating Procedures (SOPs), Protocols, Forms, and Checklists
that cover all aspects of the business. The degree and level of
documented process is compatible with the type of work, methods
used, and skill of the personnel.

Policies, processes, and their supporting documentation are in

place to preclude the use of obsolete or non-applicable documents.
Retained obsolete documents are suitably annotated. Appropriate
processes are implemented to standardize the formatting issue,
approval, distribution, control and subsequent maintenance of the
QMS documentation.
1.2 Auditing Procedures

Varian, Inc. ensures the effective implementation of the
documented procedures through regular internal and external
audits.
As a matter of policy, Varian, Inc. conducts planned and
documented internal quality audits to verify compliance with
authorized procedures and to assess the effectiveness of the
quality system. To ensure that corrective or preventative action is
effective, trending analysis and follow-up audits are conducted.
Auditing procedures ensure that quality records are maintained as
evidence that the required controls have been satisfactorily applied.
External audits include certification audits, audits of our suppliers,
and auditing of us by customers.
Varian, Inc. also undergoes bi-annual compliance audits and
triennial system re-certification audits conducted by an external
standards body, to ensure that it continues to meet the
requirements of the ISO9001:2000 standard.
1.3 Employee Qualifications and Training

Varian, Inc. ensures that all staff members are suitably qualified to
perform their role on the basis of education, job training, and
experience. Varian identifies and provides additional training where
necessary, ensuring that all personnel perform their jobs to a
standard of excellence.
Varian, Inc. representatives undergo an extensive training program
that includes formal theoretical and practical laboratory training.
They must pass an examination at the completion of training before
they can be accredited to work on a specific instrument, model, or
technique. These formal training programs include manuals and
training aids that are prepared in accordance with Quality
Procedures at Varian, Inc. Throughout their careers, Varian, Inc.
representatives receive ongoing training in order to stay technically
proficient with new instruments, new technologies, and software
changes.

2. Regulatory Compliance and

Analytical Instrument
Qualification
This chapter provides a basic overview of regulatory compliance and Analytical Instrument
Qualification.
2.1 Good Laboratory Practice

Good Laboratory Practice (GLP) can be defined as a system of
processes and conditions under which laboratory tests and/or
experiments are planned, performed, monitored, recorded, and
reported. GLP aims to ensure a defined level of quality, accuracy,
reproducibility, and validity within laboratories. GLP relates to the
organization, processes, and conditions, under which studies are
planned, performed, monitored, recorded, and reported.
Compliance with GLP also ensures that an auditor can easily audit
a laboratory’s records. An auditor should be able to determine why,
how and by whom the work was done, who authorized the results,
what equipment was used, the calibration of equipment, and the
results obtained. An auditor also needs to be able to see Out Of
Specification (OOS) results or atypical results and the Corrective
Action and Preventative Action process (CAPA) associated with
these results.
GLP is more generally applicable to drug development and
manufacture in the pharmaceutical industry. The US code for GLP
is described under the FDA in 21 CFR Part 58.

2.2 Current Good Manufacturing Practice

Current Good Manufacturing Practice (cGMP) is a standard of
Quality Assurance (QA) and Quality Control (QC) associated with
the manufacturing process. It ensures that products are
consistently produced to a set standard appropriate to their
intended use. The FDA code of cGMP for pharmaceutical
applications is described in 21 CFR Parts 210 and 211.
The most significant difference between GLP and cGMP is
archiving requirements for test samples and data. The cGMP
relates to the part of Quality Assurance that assures that products
are consistently produced and controlled to the standards
appropriate for their intended use.
The FDA regulations for GLP and cGMP are internationally
recognized as the benchmark standard for pharmaceutical
manufacturing.
2.3 Analytical Instrument Qualification

Analytical Instrument Qualification (AIQ) activities can be viewed as
an integral part of a QA program. AIQ is one of the most important
components and requirements of GLP and cGMP regulation. AIQ is
a continuous evaluation of processes, products or methods
ensuring compliance with product or method requirements.
Analytical Instrument Qualification includes:
• The assessment of equipment hardware, software, and
systems.
• The assessment of methods and data acquisition.
• The checking of functions related to data integrity, security,
and traceability.
Analytical Instrument Qualification covers the entire lifecycle of a
system, from the initial definition, design requirements, and
specifications to the cessation of its operation. AIQ includes on-
going change control procedures and archiving and retrieval of
data.
The system is qualified at the following times:
• As it is developed and tested.
• As it is installed and commissioned.
• Whenever significant changes are made.

• Periodically, under routine operation.

Analytical Instrument Qualification requires testing of:
• The individual instrument and each component of the system.
• The computer when connected to the system.
• The entire system working together.
AIQ is typically made up of Design Qualification (DQ), Installation
Qualification (IQ), Operational Qualification (OQ), Performance
Qualification (PQ), Re-qualification and Preventative Maintenance
(PM).
Qualification is an efficient, scientific-based approach to providing
documented evidence that an instrument or procedure consistently
operates or runs within established limits and tolerances.
Qualification includes the proper maintenance (including PM) and
calibration of the instrument.
2.4 When is AIQ Required?

Analytical Instrument Qualification is commonly required by
government regulation of the pharmaceutical industry and by quality
assurance schemes within the industry itself.
Regulatory compliance is complicated by a number of factors:
• Legislative requirements between different countries.
• Each particular aspect of design, manufacture or operation of
an instrument may be regulated under a number of
jurisdictions, including drug authorities, environmental
authorities, and Health and Safety authorities.
• Within individual regulatory agencies, there may be variation in
the way the legislative instruments are administered,
depending on the personnel involved.
• Much of the regulation is outcome-based. Therefore, providing
the objectives of the regulation are met, you can choose the
appropriate means to get there (this is in contrast to
prescriptive regulation, which details precisely how to do
something on the assumption that if the directions are
followed, then the desired outcome automatically results). As a
result, it is possible that the outcome-based legislation can be
interpreted in different ways.
Instrument hardware should be qualified prior to routine use, after
repair and at pre-defined regular intervals, as should be detailed in
SOPs. Computer systems should be qualified during and at the end

of the development process, during installation, prior to and during

routine use, and after software updates. Computerized systems
and data validation, with respect to consistency, security, integrity,
and traceability, is one of the most critical steps within
computerized systems. It includes authorized and traceable access
to systems, applications, methods and data as well as the
electronic audit trail and mechanisms to delete or change records
(electronic change control management).
Analytical systems should be tested for system suitability prior to
and during routine use.
The final AIQ Report with respect to the use of an instrument will
include the DQ, IQ, and OQ Protocols.
Note: The qualification of analytical methods is outside the scope of this
document. Each user’s method will be different, depending on the
requirements of their application. This document provides some
information on system features that the user will find helpful during
their method validation.
2.5 FDA 21 CFR Part 11 Electronic Signatures and Records

The FDA has developed a guidance document for a standard of
electronic signatures and records called 21 CFR Part 11.
‘An electronic record is any combination of text, graphics, data,

audio, pictorial, or other information representation in digital form
that is created, modified, maintained, archived, retrieved or
distributed by a computer system.’
‘An electronic signature is a computer data compilation of any
symbol or series of symbols, executed, adopted, or authorized by
an individual to be the legally binding equivalent of the individual’s
handwritten signature.’
FDA 2005: www.fda.gov
With a general move within the analytical instrumentation industry

towards electronic signatures and records, compliance with 21 CFR
Part 11 is becoming increasingly important across the analytical
scientific industry, in particular in the pharmaceutical industry.
Varian, Inc. is committed to assisting customers in complying with
the FDA, 21 CFR Part 11 rule. In order to achieve this, Varian, Inc.
has developed specific software which can assist instrument
operators in setting up their testing under 21 CFR Part 11
conditions.

For details on how we assist users to achieve 21 CFR Part 11

compliance, refer to the following publications:
• 21 CFR Part 11 Electronic Records, Electronic Signatures
Compliance with Varian, Inc. Spectroscopy Instruments,
publication number 8510191800.
For ICP Expert II and UV Dissolution software, publication
number 8510226300
• Regulatory Compliance in Galaxie™ Chromatography Data
System Software
2.6 Design Qualification

Analytical Instrument Qualification starts with Design Qualification.
This involves:
• Description of the analysis problem.
• Selection of the analysis technique.
• Establishing that the instrument is the correct choice for the
intended purpose, application, and business requirement.
• That ‘fitness for purpose’ is built into the procurement process.
• Planning and documenting the specifications for the user’s
requirements.
• Detailing the required instrument functions and intended use.
• Specifying the required final performance from the instrument.
• Selection of the supplier.
• Preliminary selection of functional and performance or
operational specifications (technical, environmental, safety).
• Refining testing parameters for new techniques.
• Developing the instrument Hardware/Operation Manual, Pre-
installation Manual, Service Manual, etc. for the final
instrument.
Design Qualification defines the functional and operational
specifications of the instrument and details the conscious decisions
in the selection of the supplier. It includes the development and
documentation of the final functional and operational specification.

The purchaser should prepare a list of instrument requirements and

parameters, both operational and functional. The vendor is chosen
and the system purchased according to these requirements.
The vendor provides the operational and functional specifications
and information of the available system. This ensures that the
system meets the user’s own specifications and requirements.
Upon request, the vendor will supply details of:
1. The use of rigorous design and specification methods during
system development.
2. Fully documented quality control and quality assurance
procedures.
3. The use of suitably qualified and experienced personnel.
4. Comprehensive planned testing of the system.
5. The application of stringent change control, error reporting,
and corrective procedures.
2.7 Installation Qualification

The IQ Protocol is documented verification that all hardware and
software components have been correctly installed and adhere to
the system specification and to the appropriate local statutory
requirements, for example, equipment, software, wiring and gas
supply.
Installation Qualification verifies and documents that the instrument
has arrived as specified in the purchase order documentation, that
it has been properly installed in the selected environment, and that
the environment is suitable for the operation and use of the
instrument. The IQ Protocol is divided into pre-installation
specifications and requirements for use during the installation
process.
Pre-installation instructions from the instrument supplier specify the
following:
• Environmental requirements for the instrument, including
temperature control, humidity, dust-controlled environment.
• Water, gas, or electrical requirements.
• Ventilation around the instrument.
• Magnetic interference or Radio Interference (RI) from or to the
instrument.
The IQ includes switching on the instrument and checking error
message responses.

2.8 Operational Qualification

The OQ Protocol is documented verification that the system
functions and performs in the user’s laboratory in accordance with
the operational specification, throughout all anticipated ranges in
the selected environment, as defined by the DQ.
2.9 Performance Qualification

The PQ Protocol is documented verification that the total
instrument system has been demonstrated to consistently perform
to a specification appropriate to its routine and intended use. The
PQ focuses on the instrument’s reliability, accuracy, and
reproducibility of data and test results.
On-going PQ includes PM and regular tests such as system
suitability and quality control analyses with the creation of QC
charts for tracking test results and trend analysis of the data. For
computer systems, it also includes regular data backup, virus
checks, and change control procedures.
The user generally defines a series of tests that are necessary to
demonstrate that the system is functioning properly, both for the
initial OQ and for ongoing PQ. These tests will be clearly
documented and include:
1. Rationale for tests selected and not selected for the PQ.
2. Tests specific to individual components.
3. Tests specific to the entire system.
4. Frequency, both routine and as triggered by event/change.
5. Expected results, Acceptance criteria - Pass/Fail status.
6. How the tests are documented.
7. Required qualifications of the operator.
8. Action to be taken in the event of failure of a test.
Verification is required within the intended operating ranges within
the laboratory environment.
Varian, Inc. may assist with PQ through the OQ Analytical
Qualification Protocols and suggested PM and routine maintenance
measures.

2.10 Preventative Maintenance and Re-qualification

Preventative maintenance, as a standard routine procedure, can
assist in the reduction of incident failure or breakdown. The aim of
PM is to detect potential instrument problems before a breakdown
occurs including the replacement of consumables and spare parts
at an appropriate, early stage. Routine PM testing can assist in the
reduction of Out Of Specification and Atypical test results, due to
the instrument. Undertaking trend analysis over time will help to
identify any minor issues before they become major issues.
Re-qualification is necessary after spare part replacement,
instrument repair or moving the instrument. Depending on the
change made to the instrument, a complete OQ may not be
necessary. It may only be necessary to perform components of an
OQ Protocol procedure.
Usually the manufacturer will provide information with respect to the
extent of OQ necessary during repair procedures.
On moving an instrument, a partial OQ is sufficient with respect to
verification of the performance and function of the instrument
components that may have been affected during the move.
Re-qualification is the repetition of specific qualification processes,
as triggered by events such as:
• Replacement of parts.
• Movement or relocation of equipment.
• Addition of new equipment.
• Modification, for example, instrument upgrades or
enhancements.
• Updated software.
• A change of use.
• A new procedure.

3. Analytical Instrument
Qualification at Varian, Inc.
This chapter provides an overview of Analytical Instrument Qualification procedures at Varian,

Inc.
3.1 Development of Varian, Inc. Instruments

Analytical Instrument Qualification requires a history of the
instrument and the processes involved in its design and
development, including firmware.
The product development of all Varian, Inc. instruments and
accessories is controlled by the Quality procedures in place under
ISO 9001:2000 certified Quality Management System. Product
Development follows a five phased process:
1) Product proposal
To become part of the company’s product development strategy,
an idea for a new or enhanced product must be formally proposed
in writing, and the documents must be reviewed and approved by
senior management.
2) Feasibility, product specification and planning

The approved product concept or idea then needs verification to
ensure that technical risk is minimized. This is done prior to the
design and development phase. In conjunction with this, factors
relating to market timing, costs, project planning, and customers’
needs are explored in greater detail. Out of this verification,
Marketing generates a Product Requirements Specification in
conjunction with R&D. A Product Design Concept, which defines
the product system concept and details at a high level the major
modules (mechanical, electronic, optical, firmware) and their
interactions, is also prepared by R&D. Typically, a Program
Manager/Project Leader is appointed at this stage.

3) Detailed design, development and evaluation

Detailed product design and design verification is conducted to
meet the Product Requirements Specification. This involves
prototyping and performance testing to verify that the design meets
product performance, safety, and statutory requirements
specifications. Design engineers are required to keep fully logged
details of relevant design drafts and calculations, tests, and
experiments. Throughout the product development process,
Program and Project Managers convene regular and frequent
project status meetings. Attendees include the engineers and
marketing representatives whose work is being reviewed, the
relevant engineering manager, and other staff as selected by the
project manager. During these meetings, design validation and
project progress is reviewed to ensure that the final instrument
meets the regulatory, quality, performance, safety, reliability, and
durability requirements.
4) Product introduction
A small number of units (typically five) are built to specification to
confirm that the design can be produced from the formal design
documentation package. It also allows the development and
verification of production fixtures, production routings, assembly
instructions and work centre layouts. Design Validation is carried
out using pilot units to test for conformance to requirements.
Pre-production Run (PPR) or Pilot Run is undertaken in conjunction
with the R&D department to confirm that the instrument can be
made in a reproducible manner and that the designed quality and
testing procedures are adequate to eliminate any future
manufacturing or operational issues. PPR includes the assembly
and test procedures (including SOPs and WIs), equipment and/or
routings, factory floor layout, training of shop floor personnel, and
provides a final validation that the product meets specifications and
is ready for release to the market. Once the PPR has been
completed and any problems raised have been addressed,
responsibility for maintenance of the product and Quality Control
transfers to Manufacturing.
5) Routine production and manufacturing

During the early stages of production, any problems encountered
with instrument assembly or testing are addressed through a
variety of meetings. These meetings consist of a team of suitably
qualified personnel, whose task it is to isolate and overcome any
problem(s) found.

Once any issues associated with the release of the product have
been rectified, any concerns raised by customers and/or technical
and service staff are addressed by a Corrective Action Team
(CAT). The CAT is made up of various specialists from every
aspect of product release. They meet regularly to deal with any
production or hardware problems, and ensure that all Varian
hardware is subject to continuous improvement. Issues addressed
at the CAT meetings are recorded along with a brief description of
the problem, actions to be taken, and responsibility for the actions.
Problems are ‘closed out’ once appropriate corrective and
preventative action has been effectively put in place.
Varian, Inc. can provide you (for vendor selection purposes) or the
authorities (for regulatory compliance purposes), with access to
detailed information and records relating to an instrument or
system. Information relating to the development of instrument
hardware is housed at Varian, Inc. and is available for review by
customers upon request — subject to their signing the appropriate
non-disclosure agreements. This information includes project
requirements, time lines, status reports, tests and test results
undertaken during development, instrument schematics, and
reports.
3.2 Development of the Varian, Inc. Software

Standard application software (as supplied by Varian, Inc.) is
validated by Varian, Inc. during its development. It is the user’s
responsibility to validate user-developed software. In instances
where the software allows the user to export the analytical results
to another format, for example ICP Expert II converted to an ASCII
file, any further process of this data is entirely specific to, and
validated by, the user and falls outside the scope of this package.
The software development life-cycle process is detailed in the
Software Product Development procedure in the ISO 9001:2000
certified Quality System. The cycle is an auditable process that
ensures each project stage can be revisited at any time during the
project for further refinement.

Development of the Varian, Inc. software is concentrated into four

stages, as follows:
1. Requirements
2. Analysis and Design
3. Implementation
4. Evaluation and Release
When all of the deliverables for each stage are complete, a formal
review and approval process is conducted. This process allows a
set of project checkpoints to control the development process and
ensures that the relevant managers are assessing compliance and
Quality procedures throughout the development cycle. Checkpoints
ensure that the requirements of a stage have been met, reviewed,
and approved before the next stage is commenced.
1) Requirements
A definition of the user requirements for the Varian, Inc. software is
established. This involves a series of meetings between the
Marketing and Research and Development departments. The
meetings address design and development planning, and produce
an agreed set of Product Requirements. In order to tailor the
Varian, Inc. software to the needs of customers, extensive user
input is also incorporated into the system design and development.
2) Analysis and Design

The Software Requirements Specification document is analyzed to
determine the possible problems and constraints of the software
system. This analysis forms the basis of the analysis model, which
is used to define the scope of the software system.
System design, which commences once analysis design is
complete, provides the structure of the Varian, Inc. software for use
on Varian instruments. Documentation outlining the overall
framework of the software, including its interfaces, is also
developed.
3) Implementation
The source code for the Varian software is developed, modified,
and maintained in accordance with work instructions outlined in the
Varian, Inc. Quality System. These instructions ensure that reliable
and consistent software is produced.
For security purposes, the source code files are kept on a central
file server during software development. Only project staff involved

in developing the software have access to these files. The code is

regularly backed up onto safe storage and kept onsite in a fireproof
safe and at an offsite location.
4) Evaluation and Release
Evaluation includes testing of requirements outlined in the
specifications for both hardware and software. The software is
thoroughly tested and evaluated to detect and eliminate any
potential ‘bugs’ in the system in accordance with work instructions
outlined in the Varian, Inc. Quality System. Once this process is
complete, the software is released.
3.3 Pre-installation
Varian, Inc. provides a Pre-installation Manual to all customers
when an order is verified. This manual includes all the information
required for the customer to prepare their site for the arrival and
installation of the instrument or system.
It is the customer’s responsibility to ensure that the computer
system to be used is appropriate for the requirements of the
instrument system purchased; when requested, Varian, Inc. can
provide the personal computer. Validation of systems and software
from Varian, Inc. assumes that the computer hardware and its
operating system are correctly functioning.
Further information can also be provided by your local Varian, Inc.
representative.
3.4 IQ Documentation Provided by Varian, Inc.

Varian provides an IQ Protocol that details all necessary test
procedures required to qualify the assembled equipment. The IQ
Protocol ensures the equipment is installed as specified in the
selected environment and that the environment is suitable for the
operation of the equipment. The IQ Protocols are specific to each
type of instrument installation and are designed to help customers
meet their GLP and cGMP requirements.
Each IQ Protocol contains a section specifically dedicated to 21
CFR Part 11 (where applicable). This section exists only for
products that include 21 CFR Part 11 software. The 21 CFR Part
11 section is designed to assist the customer with setting up the
instrument to assist with compliance to the 21 CFR Part 11
requirements.

The Varian Installation Qualification Protocol package includes:

• Tests to be performed, addressing process critical
components, site requirements, and media connections.
• Sequence of test execution.
• Acceptance criteria.
• Change control procedures for documentation.
• A Variation List for results that vary from the expected
criteria, with appropriate identification and resolution
sections.
• A standard method for recording raw data from the
execution of the Protocols, specific to each test. This
includes acceptance criteria, comment fields, and signature
blocks.
• Completion of the IQ Protocol so that the OQ testing can
commence.
Completion of an IQ Protocol is the responsibility of the user.
However, for the majority of Varian instruments, Varian, Inc.
provides IQ Protocol documentation. For the majority of Varian
systems, the Varian Service Representative will install the
instrument and components, and assist the customer with the IQ
Protocol. In most instances, the Varian Service Representative will
perform the complete IQ Protocol with the customer watching and
learning about the instrument and its operation.
3.5 OQ Documentation Provided by Varian, Inc.

Varian, Inc. provides an OQ Protocol containing the critical steps
for OQ Validation, ensuring on-going trouble-free operation of the
system. Protocols check for proper functioning of the system. The
OQ Protocols are specific to each type of instrument and are
designed to help customers meet their GLP and cGMP
requirements.
The Varian Operational Qualification Package includes:
1. Sequence of test execution.
2. Acceptance criteria for all tests.
3. A standard method for recording raw data from the execution
of the Protocols, specific to each test. This includes
acceptance criteria, comment fields, and signature blocks.

Completion of the OQ is the responsibility of the user. However, for

the majority of their instruments, Varian, Inc. provides OQ Protocol
documentation. For the majority of Varian systems, the Varian
Representative will perform the complete OQ with the customer
watching and learning about the instrument and its operation.
3.6 Re-qualification
The process of re-qualification and the frequency of this procedure
is the responsibility of the customer to perform and to document in
their internal quality system. For the majority of Varian instruments,
re-qualification information and lists can be provided. Contact a
local Varian Representative for assistance with re-qualification.
Where necessary, a Varian Representative can perform re-
qualification procedures on request.
Contact the Original Equipment Manufacturers (OEM) of the
accessories for assistance with re-qualification of those
accessories.
The user’s company should have a quality assurance program
following basic GLP and cGMP principals in place to prevent,
detect, and correct problems. This should include:
• Change control program.
• Security plan.
• Backup and data recovery plan.
• Training program, including the assessment of training,
training records, and a procedure for on-going refresher
training.
• Periodic re-evaluation of the system as a whole, and
components within the system.
• QMS and Documentation Control systems.
• Preventative maintenance, calibration procedures, and re-
qualification plans.
• Procedures for how to handle defective equipment, OOS
results, atypical results and equipment breakdown.
Refer to the instrument Operation Manuals/User Manuals provided
by Varian, Inc. for advice on setting up your maintenance program.

3.7 AIQ Package Provided by Varian, Inc.

Varian’s Analytical Instrument Qualification Package is made up of:
1. AIQ Overview — containing company information
2. Installation Qualification (IQ)
3. Operational Qualification (OQ)
Note: Varian does not provide IQ/OQ instructions for non-Varian
manufactured items. Limited instructions may be supplied. If IQ/OQ
of an accessory is required, contact the appropriate manufacturer.

3.8 Summary of Purchase and Qualification Procedures with

Varian, Inc.
• Varian, Inc. launches new instrumentation.

• Upon request, Varian, Inc. provides details of the DQ and
development of the instrument.
• An order is placed for the Varian, Inc. system.
• The customer receives the Pre-installation Manual containing
a Pre-installation Checklist.
• The customer ensures the site meets the conditions outlined
on the Pre-Installation Checklist.
• The customer may receive the Analytical Instrument
Qualification package prior to or with the delivery of the
instrument.
• The customer is briefed on the Analytical Instrument
Qualification package. The IQ and OQ requirements at
installation are confirmed.
• The customer prepares their plan for verifying and maintaining
system performance (PM, PQ, and Re-qualification).
• The Varian system is delivered.
• The Varian Representative goes to the customer’s site,
ensures that all pre-installation requirements have been met,
and installs the instrument.
• As requested, IQ and OQ Protocols are completed.
• The customer completes their Quality plan for on-going
instrument qualification, PM, PQ, and Re-qualification.
• The Analytical Instrument Qualification package is used as a
reference throughout the life of the system.
• Varian, Inc. provides on-going support, service, extended
warranties, training, and re-qualification as requested.

3.9 Regulatory Compliance

Varian, Inc. is committed to assisting their customers in achieving
compliance with regulatory bodies. Although Varian, Inc. is
knowledgeable and experienced in the regulatory requirements of
many countries, including the FDA and TGA, and pharmacopoeia
method requirements as in the USP, BP, EP, JP and other
regulations and methods, information provided in this document
does not guarantee complete regulatory compliance. The
information in this document and the tools provided by Varian, Inc.
provide a foundation on which the user can build. They can also be
used to assist in meeting particular regulatory requirements specific
to the regulations at a specific location. Although the user is
ultimately responsible for validation of the Varian instrument or
system at their site, as the manufacturer, Varian, Inc. provides
appropriate information, documentation (Protocols), and services to
assist in this task.
For details on how we assist users to achieve 21 CFR Part 11
compliance, refer to the following publications:
publication number 8510191800.
Compliance with Varian, Inc. Spectroscopy Instruments, For
ICP Expert II and UV Dissolution software, publication number
8510226300.
• Regulatory Compliance in Galaxie™ Chromatography Data
System Software

4. Customer Support
This chapter provides an overview of Customer Support Services provided by Varian, Inc.
4.1 Global Sales and Support

The company’s global direct sales force remains one of the core
competencies that have resulted in the success of our multi-
product and multi-application business. Our global presence and
our ability to provide customers with a wealth of technical expertise
and applications know-how, contributes directly to our continuous
worldwide growth. We will continue to invest in our global
distribution and support capabilities to help further drive our growth
and to consistently support our customers.
Varian, Inc. offers a variety of analytical instrument support
agreements to accommodate a range of customer needs and
budgets. In some countries, a technical support hotline is provided
free of charge with all warranty and support agreements.
We believe that our Customer Service and Support are an integral
part of our competitive strategy. As part of our services, our
applications and technical staff provide individual assistance in
supporting the specific application needs of customers, solving
analysis problems. We offer training courses and routinely send our
customers information on applications development.
The customer support organization of Varian, Inc. is one of the
largest, most widespread support networks in the industry. The
Field Support Group located at Varian, Inc. factories are available
to assist the Varian representative resolve issues that arise.
Varian, Inc. provides customer service and support throughout the
life cycle of the instrument. The customer support team will assist
with all stages of instrument usage, from the initial instrument
inquiry, the purchase of the instrument, the follow-up of the
purchase and on-going support. Additional service warranties,
support agreements, and training are available on request.

Various methods for obtaining information are available depending

on your country, including the following:
• Varian, Inc. Web site is a primary source of information
• Newsletters
• Customer surveys
• Notification of software upgrades or hardware updates
• Regulatory compliance – notification of upgrades
• E-inspirations
• PlasmaNet
Support will vary depending upon the country and the type of
service contract provided. Contact your local Varian office for
information about the services that can be provided locally.
4.2 Varian Customer Training Courses

Varian, Inc. offers a variety of training courses for varying levels of
proficiency, ranging from basic instrument operations, maintenance
and troubleshooting to advanced applications. Details of the dates
and locations of such courses can be obtained from the Varian
Web site, or by contacting local support offices. Alternatively,
customers can arrange for a Varian instructor to visit their facility
and conduct a user-specific training program.
See www.varianinc.com for further details.
4.3 Support Agreements

Varian, Inc. has a global network of service offices, providing local
language support. The type of services these offices provide will
vary depending on the country. Information regarding specific
details of support agreements and their costs is available from your
local Varian representative.
Our products generally include a 90-day to one-year warranty, but
in some countries, for some products, we offer longer warranties.
Support agreements may be purchased by customers to cover
equipment no longer under warranty. Service work not performed
under warranty or support agreement is generally performed on a
time-and-materials basis. We install and service our products
primarily through our own field service organization, although
certain distributors and sales representatives are able to, and are
contracted to perform some field services.

4.4 Consumables and Spare Parts

With ever-changing developments in technology, new instruments,
software and systems are continuously being developed at Varian,
Inc. in response to industry demands.
Varian, Inc. provides full spares support for all instrumentation,
software and systems currently in production. Varian, Inc. provides
full spares support for discontinued instruments and accessories,
for a minimum period of five years from the date of production of
the last instrument or accessory, or from the official date that the
instrument, or accessory was replaced with a superseding model.
The supply of spare parts after the minimum five-year period is on
an ‘as available’ basis. That is, the part will be supplied as a spare
if the part is on the Varian Price List, or if the part is used in the
production of a current product.
Varian is dedicated to adapting new software versions for
superseded instrumentation where possible, particularly with
respect to 21 CFR Part 11 compliance.
4.5 Instrument Installation Procedure

Varian Quality Procedures define the requirements for the
installation of a Varian product at a customer’s location. Customers
will be provided with a Pre-installation Checklist, which must be
reviewed and the site set up appropriately as per these
requirements. Varian will then schedule and perform the instrument
installation, and ensure that any installation problems are
satisfactorily resolved.
Varian systems are designed to be installed with the assistance of
a Varian representative. The following procedure applies only when
a Varian representative carries out the installation. At installation,
the Varian representative will perform tests to ensure that the
system is performing to stated specifications. Customers will be
given a copy of these test results. The Varian representative will
also demonstrate the basic operation of the system to the
customer.
See Chapter 3, Sections 3.3 to 3.6 for more information.

End of Document.

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Varian, Inc.

Varian, Inc. – Serving Industries Worldwide

Sales and Service Contact Details

Varian, Inc. Web Site

Varian, Inc. is the owner of copyright on this document and any

First published December 2005. Updated in February 2008.

Page 2 of 36 Publication no. 8510228900, Issue 3, February 2008

Varian, Inc. Industry Awards ........................................................ 5

Publication no. 8510228900, Issue 3, February 2008 Page 3 of 36

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Varian, Inc. Industry Awards

Varian, Inc. Awards:

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1994 Australian Institute of Engineers – Highly Commended

Page 6 of 36 Publication no. 8510228900, Issue 3, February 2008

Preface - Varian, Inc.

Introduction to Varian, Inc.

Inspiring Excellence™ is at the Heart of Our Business.

Varian, Inc. is a diversified, global technology leader helping

Publication no. 8510228900, Issue 3, February 2008 Page 7 of 36

History of Varian, Inc.

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Real World Applications

• Varian HPLC columns are used in a broad range of industries

Publication no. 8510228900, Issue 3, February 2008 Page 9 of 36

Page 10 of 36 Publication no. 8510228900, Issue 3, February 2008

This document provides an outline of the commitment to Quality at

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This page has been intentionally left blank.

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1.1 Quality Management System

Our Quality Policy states:

‘Varian, Inc. and its people are committed to meeting or exceeding

The Quality Management System (QMS) is supported by

Publication no. 8510228900, Issue 3, February 2008 Page 13 of 36

Policies, processes, and their supporting documentation are in

1.2 Auditing Procedures

1.3 Employee Qualifications and Training

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2. Regulatory Compliance and

2.1 Good Laboratory Practice

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2.2 Current Good Manufacturing Practice

2.3 Analytical Instrument Qualification

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• Periodically, under routine operation.

2.4 When is AIQ Required?

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of the development process, during installation, prior to and during

2.5 FDA 21 CFR Part 11 Electronic Signatures and Records

‘An electronic record is any combination of text, graphics, data,

With a general move within the analytical instrumentation industry

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For details on how we assist users to achieve 21 CFR Part 11

2.6 Design Qualification

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The purchaser should prepare a list of instrument requirements and

2.7 Installation Qualification

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2.8 Operational Qualification

2.9 Performance Qualification

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2.10 Preventative Maintenance and Re-qualification

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