w w w. s p e c t r o s c o p y o n l i n e .

c o m November 2013 Spectroscopy 28(11) 1

Focus on Quality
An Integrated Risk Assessment
for Analytical Instruments
and Computerized Laboratory
Systems
A risk assessment is presented for determining the amount of qualification and validation work
required to show that instruments and computerized laboratory systems are fit for their intended
purpose.
C. Burgess and R.D. McDowall

R isk management is one of the new requirements for

the pharmaceutical industry following the publica-
tion of the Food and Drug Administrations (FDA)
Good Manufacturing Practices (GMPs) for the 21st
Century (1) and the International Conference on Har-
monization (ICH) Q9 on Quality Risk Management (2).
How much qualification and validation work is required in
connection with a regulated task is dependent on a justi-
fied and documented risk assessment. The United States
Pharmacopoeia (USP) General Chapter <1058> (3) on ana-
lytical instrument qualification (AIQ) has an implicit risk
assessment in that it classifies instrumentation used in a
regulated laboratory into one of three groups: A, B, or C.
The chapter defines the criteria for each group, but leaves it
to individuals to decide how to operate the classification in
their own laboratories.
Software is pervasive throughout the instruments and
systems in groups B and C, as acknowledged by <1058>
(3). From a software perspective, Good Automated Manu-
facturing Practice (GAMP) 5 Good Practice Guide (GPG)
for Validation of Laboratory Computerized Systems (4)
is widely recognized within the industry and by regula-
tors, but it is not consistent with some of the elements of
USP <1058>. The USP general chapter is currently under
revision and ideally the revised version will be fully com-
patibility with the GAMP 5 guidelines and good practice
guides (46). In the meantime, however, users are left with
a question: Do I follow USP <1058> or GAMP 5? We shall
answer this question here.
Some Problems with USP <1058>
In November 2010, there was an American Association
of Pharmaceutical Scientists (AAPS) meeting in New Or-
leans, Louisiana, where the status of <1058> was debated.
That same month Bob published some of his thoughts
about the advantages and disadvantages of that general
chapter (7). The advantages consisted of the classification
of instruments and systems, which was also its greatest
disadvantage, as it was too simplistic. Simply saying that
an instrument fit into group B ignored the possibility that
there were in-built calculations that needed to be verified
because of 21 CFR 211.68(b) requirements (8) or that some
instruments enable users to build their own programs.
Furthermore, the approach to software for group C sys-
tems was nave as it placed the responsibility for valida-
tion on the supplier rather than the user. Chapter <1058>
2 Spectroscopy 28(11) November 2013
Table I: Increased granularity of existing USP <1058> instrument groups
USP <1058> Group Suggested Qualification and Validation Approach
Group A (Apparatus)
No measurement or calibration requirements
Compliance by observation
No user defined qualification or calibration requirements
Group B (Instruments)
Type 1: Instrument
Qualification of the instrument operating parameters
Implicit validation of software functions through the
only
qualification of the instrument
Qualification of the instrument operating parameters
Type 2: Instrument Implicit validation of software functions through the
with embedded qualification of the instrument
calculations Explicit verification of the calculations used by individual
laboratory
Qualification of the instrument operating parameters
Type 3: Instrument Implicit validation of instrument software functions
with user-defined through the qualification of the instrument
program capability User-defined programs require specification and
verification that they work as intended
Group C (Systems)
Qualification of the instrument using the control software
Type 1: Low Documents user types and corresponding access privileges
complexity system System life cycle for nonconfigurable software or
configurable software used with default settings
Qualification of the instrument using the control software
Type 2: Medium Document user types and corresponding access privileges
complexity system Document software configuration
System life cycle validation for configurable software
Qualification of the instrument using the control software
Documents user types and corresponding access privileges
Type 3: High
Document software configuration
complexity system
System life cycle validation for configurable software
Specification and verification of the custom modules or
macros
also referenced the FDA guidance for and validation of instruments and
industry entitled General Principles computerized laboratory systems (The
of Software Validation (9), which was GAMP GPG uses the term laboratory
written primarily for medical devices; computerized system in contrast to the
the configuration and customization more common term of computerized
of software is not mentioned tehre. laboratory system; however the two
terms are equivalent.) We have a paper
GAMP Good Practice Guide for soon to be published that maps the
Laboratory Systems Updated two approaches and shows that they
The publication of the first edition of are very similar despite some differ-
the GAMP Good Practice Guide for ences in terminology (12).
Validation of Laboratory Computer-
ized Systems (5) had some problems. Progress Updating USP <1058>
However, in the recently published The original basis of USP <1058> was
second edition (6), the good practice the 2004 AAPS white paper Analyti-
guide was aligned with GAMP 5 (4) cal Instrument Qualification, which
and was updated to be risk-based focused on a risk-based approach to
(as reflected in the new title). Col- AIQ by classifying apparatus, instru-
laboration with us during the writing ments, and systems depending on the
enabled both the good practice guide laboratorys intended use. The defini-
and the new draft of USP <1058> (11) tion of the intended use is the key part
to be more closely aligned and have of the process, because the same item
a unified approach to qualification could be classified in any of the three
w w w. s p e c t r o s c o p y o n l i n e . c o m
groups depending on its use. Intended
use is also an essential part of our risk
assessment presented in this column.
However, the current weakness
of the overall risk-based approach
is the way in which software is as-
sessed. Software is pervasive in group
B instruments and group C systems.
Chapter <1058> currently references
the FDA guidance document, General
Principles of Software Validation (9).
This guidance was written primarily
for medical device software, which is
neither configured (modified to the
business process by vendor supplied
tools) nor customized (writing soft-
ware macros or modules that are in-
tegrated with the application). Given
that many analytical instruments and
systems are configured or customized,
this guidance does not fit well in a
regulated GXP laboratory environ-
ment.
In January 2012, we published a
stimulus to the revision process in
the on-line version of Pharmacopeial
Forum (13), in which we proposed an
update for USP <1058>. In our pro-
posal, instrument qualification was
integrated with computerized system
validation rather than being two
separate activities. This would pro-
vide regulated laboratories with the
opportunity to reduce the amount of
work and avoid potential duplication.
In this publication, we included a risk-
assessment flow chart for determining
the amount of work to perform to
qualify analytical instruments and,
where appropriate, validate the soft-
ware functions and applications. From
the comments received, we updated
the flow chart. We present it here as a
simplified method for classifying the
apparatus, instruments, and systems
in your laboratory.
Why an Integrated Risk
Assessment Approach?
The basic risk assessment model in
<1058> is the classification of any
item used in a laboratory into group
A, B, or C based on a definition of in-
tended use. This is generally a sound
approach, because apparatus (group
A), instruments (B), or systems (C)
are easily classified. However, there is
w w w. s p e c t r o s c o p y o n l i n e . c o m November 2013 Spectroscopy 28(11) 3

a weakness in that the level of granu-

larity currently offered by <1058> is
insufficient to classify the variety and AIQ and CSV risk
assessment: Define
permutations of instruments (B) and intended use and
records generated

systems (C) used in combination with

software in the laboratory today. 1. GMP
relevant?
Yes

Therefore the risk assessment pre-

sented in this column is to provide a 2. Is it only
No
means of software?

1. Unambiguously differentiating 3.

between apparatus (group A) and Instrument or

system?
Yes

instruments (group B) based on

functionality. Yes
4. Is it an
Instrument? No

2. Linking software elements with No

Yes

the various types of instrument Group B

instrument
Group C
system
(group B) and systems (group C) No
Group C

as current instrumentation is more system

complex that the simplistic use 5. Calcs or

programs?
6. System
complexity

of groups B and C in the current No calculations or User-defined Low High

version of USP <1058>. This will user programs programs complexity complexity

identify subgroups within groups

Embedded Medium
calculations complexity

B and C.
No GMP Group B Group B Group B Group C Group C Group C
Item 2 is a fundamental nonpe- relevance
excluded
Validate
software
Group A
apparatus
Type 1
instrument
Type 2
instrument
Type 3
instrument
Type 1
system
Type 2
system
Type 3
system

dantic difference and is necessary

for determining the proper extent of
qualification or validation for a spe-
cific instrument or system. Effective
risk management ensures that the ap-
propriate amount of qualification and
validation is performed relative to the
stated intended use of an instrument
or system. It does not leave a compli-
ance gap for an inspector or auditor to
find. Furthermore, verification of cal-
culations is a necessary requirement
of complying with US GMP regula-
tions, specifically 21 CFR 21.68(b) (8).
This is omitted in the current version
of <1058>.
Subdivision of Groups B and C
As mentioned earlier in this column,
software is pervasive throughout the
instruments in group B and systems
in group C.
It is our contention that subgroups
exist within groups B and C due solely
to the software present and how it is
used. The subgroups in groups B and
C are shown in Table I.
We stress that this subclassification
is important only when these features
are used (that is, intended use). Oth-
erwise, if the features are present but
not used, then they are not relevant
to the overall qualification or valida-
tion approach for the instrument or
Figure 1: Schematic of an integrated analytical instrument qualificationcomputerized system
validation (AIQCSV) risk assessment.
system. The issue then becomes one around six decision points shown in
of system scope creep; because of that, Figure 1.
the intended use of a given instrument This process flow is simpler than
needs to be reviewed regularly to en- one we originally published (11) and
sure that it is still current. This is best therefore it is easier to understand.
undertaken during a periodic review. The process consists of a preparation
phase followed by six decision stages
Approach to Risk Assessment and is completed by a sign off by the
We propose that a simple hierarchical owner with quality unit or quality
risk assessment model be used to de- assurance approval. If required, this
termine the extent of qualification or risk assessment can be adapted eas-
validation required to ensure fitness ily to focus only on groups A, B, and
for purpose under the actual condi- C to exclusion of nonGMP relevant
tions of use within the laboratory. Our instruments and software; the choice
proposed model splits the USP <1058> is yours. However, we have chosen to
groups B and C categories into three present a comprehensive risk assess-
subcategories each, as is shown in ment to cover the majority of items
Table I. used in a regulated laboratory.
Integrated Risk Assessment Preparation:
Assessment Approach Describe Item and Define
The fundamental idea is to provide an Intended Use
unambiguous assignment of category Preparing for a risk assessment is an
that is documented in a qualifica- administrative process and begins
tion and validation statement that is with describing the item using sup-
completed at the end of the risk as- plier, model, serial number, software
sessment. The process flow for this name, and version or firmware ver-
risk-assessment model is based on 15 sion (as applicable). If required you
simple, closed (yes or no) questions can also add the owner and, if appro-
4 Spectroscopy 28(11) November 2013
priate, the department and location
of the item as well as an inventory or
asset number if available.
The next, and most important, part
of this preparation phase is to describe
the intended use of the item. This is
the key to the whole risk assessment.
It is essential to be as accurate as pos-
sible and also to indicate if there are
any records created by the use of the
item (for example, paper printouts or
electronic records). The intended-use
statement should also indicate if the
item will be connected to the network
or will stand alone.
Some people may consider simpli-
fying the intended use statement, but
this is the most important part of this
stage. Failure to define the intended
use adequately means that the only
person who is fooled is you. Ensure
that the intended use is defined well.
For example, if an instrument has
90% of its work involved in research
and only 10% with GxP work, it is nat-
ural to focus on the research element.
However, it is the 10% of the GxP
work that is critical and determines
the overall level of control required.
Step 1: Determine GMP Relevance
The first stage of the risk assessment
is to determine if the item is carrying
out GMP work. For the sake of com-
pleteness of the risk-assessment model
we have included the possibility of
laboratory instrumentation and sys-
tems being present that are not used
for regulatory purposes. Based on the
intended-use statement from the prep-
aration stage, we ask the six closed
questions (questions 16). These have
been taken from the Society for Qual-
ity Assurance (SQA) Computer Vali-
dation Initiative Committee (CVIC)
risk assessment questionnaire (14).
This questionnaire posed 15 closed
questions to determine if a comput-
erized system carried out any GxP
activities. We have taken only the rel-
evant laboratory questions and used
them in this <1058> risk assessment.
The questions asked are related to
what is the item used for. Is the item
used for
1. Testing of drug product or API for
formal release?
2. Shipment of material, such as data
loggers?
3. Nonclinical laboratory studies in-
tended for submission in a regula-
tory dossier?
4. Clinical investigations including
supply of clinical supplies or phar-
macokinetics?
5. Generation of, submissions to, or
withdrawal of a regulatory dos-
sier?
6. Backup, storage, or transfer of
electronic records supporting any
of the above?
If all responses are no then
qualification and validation are not
necessary because the item has no
GxP function and is documented as
requiring no qualification or valida-
tion. This is highly unlikely to happen
within a GMP-regulated quality con-
trol laboratory. However, if the labo-
ratory is on the boundary between
research and development there may
be some interesting issues to man-
age. If the majority of work is carried
out for research and a minority of the
work for development (say a 90:10 split
of activities) do we focus on the 90%
or the 10%? Because there is a high
probability that the 10% will end up in
a regulatory dossier, we need to focus
on the 10% to ensure the instrument
and any software output are correct.
Furthermore, if procedures developed
using the instrument or system are to
be transferred to other laboratories
later in the lifecycle, we need to ensure
the item is under control and the out-
put is verified.
Step 2: Is the Item
Standalone Software?
At step 2 only one closed question is
asked (question 7) to determine if the
item is standalone software:
7. Is the item only software that per-
forms a GxP function or creates
GxP records?
This question should be applied
not only to recognized software ap-
plications such as statistical software
or a laboratory information manage-
ment system (LIMS), but also Excel
(Microsoft) spreadsheets and Access
(Microsoft) databases used within the
laboratory. If the answer to question
w w w. s p e c t r o s c o p y o n l i n e . c o m
7 is yes then the organizations vali-
dation procedures for computerized
systems should be followed. Again,
this question is included to ensure
completeness of coverage of the risk
assessment questionnaire for all
laboratory instruments, systems, and
software.
If the answer to question 7 is no,
then it is necessary to determine if
the item is apparatus (group A) as
opposed to instruments and systems
(USP <1058> group B or group C).
Step 3: Is the Item an Apparatus (in
Group A)?
The third step in the risk assessment
is to differentiate between apparatus
and instrumentation or systems. USP
<1058> defines group A as standard
apparatus with no measurement capa-
bility or user requirement for calibra-
tion (3). Therefore, we ask three closed
questions (questions 810) to identify
items of apparatus:
8. Is there any measurement capabil-
ity of the item?
9. Is the item user calibrated after
purchase?
10. Does the use of the item require
more than observation?
If the answer to each question is
no, then the item is classified as USP
<1058> group A. On the other hand, if
one or more answers are yes, then we
move to step 4.
Step 4: Is the Item an Instrument (in
Group B) or a System (in Group C)?
Group B includes standard equipment
and instruments providing measured
values as well as equipment control-
ling physical parameters (such as
temperature, pressure, or flow) that
need calibration. In contrast, group
C systems include instruments and
computerized analytical systems,
where user requirements for function-
ality, operational, and performance
limits are specific for the analytical
application. These systems typically
are controlled by a standalone com-
puter with specific software for in-
strument control and data acquisition
and analysis (3). To determine which
items belong in these two groups, at
step 4 two closed questions are asked
w w w. s p e c t r o s c o p y o n l i n e . c o m
(questions 11 and 12):
11. Does the item measure values or
control physical parameters re-
quiring calibration?
12. Is there a separate computer for
control of an instrument and data
acquisition?
If both answers are yes then the
item is considered a system and falls
under USP <1058> group C. However,
if the answer to question 12 is no
then the item is considered an instru-
ment and falls under USP <1058>
group B. The exact group B instru-
ment subclassification (I, II, or III) is
determined by asking three further
closed questions regarding customiza-
tion and configuration in step 5.
Step 5: Group B Instrument
Subclassification
At step 5 the three remaining ques-
tions are asked (questions 1315) to
determine the subcategory of group
B that the instrument belongs to (see
Table I). The closed questions are as
follows:
13. Are there any built-in calcula-
tions used by the instrument that
cannot be changed or configured?
14. Can you configure the built-in
calculations in the instrument?
15. Can you write a user-defined pro-
gram with the instrument?
Group B, Type 1 instruments are
indicated only if question 13 is an-
swered yes because this is an instru-
ment without any calculations or the
ability for the user to define programs.
Therefore, only qualification of the
instruments functions is required to
demonstrate its intended purpose.
Group B, Type 2 instruments are
designated if the answers to questions
14 and 13 are yes and to question
15 is no. Therefore, in addition to
qualification of the instrument the
embedded calculations need to be
verified in the way that they are used
by the laboratory.
Group B, Type 3 instruments are
classified if the answer to Q15 is yes
and the remaining two answers are
no. This type of instrument requires
qualification of the instrument plus
specification and verification of any
user defined programs. The latter pro-
5 High
category
software
Low or
GAMP
4 Medium
medium
3 Low
Low
Figure 2: Subclassification of USP <1058> group C systems by software category and record
impact.
cess could be controlled by a standard
operating procedure so that user-
defined programs developed after the
initial qualification can be validated
on the operational system. Ideally,
the user defined programs should be
controlled to prevent change by un-
authorized persons or without change
control. It is possible that Type 3 in-
struments could also have embedded
calculations, where the answer to Q14
was also yes, which would result in
these calculations being verified the
same way as Type 2 instruments.
Let us return to the intended use
statement in the preparation step dis-
cussed earlier. The instrument may be
capable of performing embedded cal-
culations or have the ability for users
to define programs. However, if these
functions are not intended to be used,
then they do not need to be verified.
Hence, you can see the importance of
the intended use statement that was
written in the preparation stage of the
assessment.
Step 6: Group C System
Subclassification
As noted in Table I, there are three
types of group C systems that need to
be differentiated. System complexity
for systems in group C is determined
by two factors. The first is the im-
pact of the records generated by the
system. Our risk assessment uses the
scheme in the GAMP Good Practice
November 2013 Spectroscopy 28(11) 5
High High
Medium
Low or
Low
medium
Medium High
Record impact
Guide Compliant Part 11 Records and
Signatures (see reference 15 for this
classification). Second, the complex-
ity of the system is determined by the
nature of the software used to control
the instrument and to acquire, pro-
cess, store, and report results. Here,
we use the GAMP 5 software classifi-
cation (5).
Determination of Record Impact
The GAMP Part 11 guide (15) identi-
fies three types of records generated
in the pharmaceutical industry:
High impact: Records typically have
a direct impact on product quality,
patient safety, or could be included
in a regulatory submission for ex-
ample, batch release, stability stud-
ies, method validation records
Medium impact: Records typically
have an indirect impact on product
quality or patient safety for ex-
ample, supporting records such as
calibration, qualification, or valida-
tion records
Low impact: Records typically have
a negligible impact on product qual-
ity or patient safety and are used to
support regulated activities but are
not the key evidence of compliance
for example, plans for qualifica-
tion or calibration activities (15)
Note that most of the records gener-
ated in a QC laboratory will typically
be high impact. However, in an ana-
lytical development laboratory there
6 Spectroscopy 28(11) November 2013
may be more of a mixture of high- to
low-impact records. In this case, the
worst case scenario should be taken to
avoid understating the risk offered by
the system.
Determination of
GAMP Software Category
The subclassification of USP <1058>
group C systems is completed by
determining the GAMP software
category or categories that are used
to control the instrument and acquire
and process data from it (4). The three
categories that we consider in this
portion of the risk assessment are
Category 3: Nonconfigurable soft-
ware in which the software cannot
be changed to alter the business
process automated. There is limited
configuration such as establishing
and managing user types and the
associated access privileges of each
one, report headers, and location of
data storage of records. However,
this limited configuration does not
change the business process auto-
mated by the software.
Category 4: Configurable software
that uses tools provided by the sup-
plier to change the business process
automated by the application. The
tools can include entering a value
into a field (such as reason for
change within an audit trail), a but-
ton to turn a function on or off, or a
supplier language. In the latter case,
the configuration should be con-
sidered under custom software.
Category 4 with category 5 custom
modules or macros: In this case,
we have the configurable software
above, but with either custom
modules programmed in a widely
available language or macros for
automating the operation of the
application that are devised and
written by the users using tools
within the application. Category 5
is the highest risk software because
it is typically unique to a labora-
tory or an organization. We will
not consider custom applications
in this risk assessment because the
overwhelming majority of systems
used in the regulated laboratory
are commercially available appli-
cations that are either category 3
or 4.
Determination of Group C Complexity
When the impact of the records gen-
erated by the system and the software
category or categories has been deter-
mined, it is compared with the grid
in Figure 2 to determine the system
complexity. This will also determine
the amount of qualification and vali-
dation work required.
As presented in Figure 2, there are
three types of systems possible in
group C:
Group C, Type 1 system: A low
complexity laboratory computerized
system where the instrument is con-
trolled by category 3 software that
generates low-, medium-, or high-
impact records or unconfigured
category 4 software that generates
low-impact records.
Group C, Type 2 system: A medium
complexity system consists of an
instrument controlled by category
4 configurable software generating
low-, medium-, or high-impact re-
cords. An alternative classification
for a laboratory computerized system
with category 3 software that gener-
ates high-impact records is that the
system can be medium complexity.
Group 3, Type 3 system: A high
complexity system is one with an
instrument controlled by category
4 software that has category 5 soft-
ware modules or macros. It can gen-
erate low-, medium-, or high-impact
records. It is the incorporation and
use of the custom or category 5
software that makes the system high
complexity, because this software is
unique and needs more control.
The approach to the control of
these systems is through a combina-
tion of qualification of the analytical
instrument with the validation of
the application software (that is, an
integrated approach). The controlling
document for this work is either a
standard operating procedure (SOP)
or a validation plan. Because of the
wide variation of systems, the first
option would be a validation plan for
high and most medium complexity
systems. For some medium and most
w w w. s p e c t r o s c o p y o n l i n e . c o m
low complexity systems, using an
SOP for validation or qualification
of simpler systems could be an easier
and more efficient approach (16). Fig-
ure 2 can also be used in a different
way, to identify the risk elements in
the different software components of
a system. Components with custom
software require more control than
those that are configured compared
with those that are not configured.
The system life cycle to be fol-
lowed and the documented evidence
required for qualification of instru-
ments and validation of the software
should be defined in a validation plan
or SOP. The details of this are outside
the scope of this column, and readers
should refer to existing approaches
(4,6).
Summary
In this column we have presented a
comprehensive risk assessment pro-
cess for classifying apparatus, instru-
ments, and computerized laboratory
systems used in regulated laborato-
ries. The intention is to demonstrate
clearly that an integrated approach to
analytical instrument qualification
and, where appropriate, computer-
ized system validation, is more ef-
ficient than separating the two tasks.
The risk assessment also ensures that
laboratories qualify or validate all
intended use functions in an item and
aims to minimize regulatory exposure
from omitting work.
References
(1) US Food and Drug Administration,
Guidance for Industry: Good Manu-
facturing Practices for the 21st Cen-
tury (FDA, Rockville, MD, 2002).
(2) International Conference on Harmo-
nization, ICH Q9, Quality Risk Man-
agement (ICH, Geneva, Switzerland,
2008).
(3) General Chapter <1058> Analytical
Instrument Qualification in United
States Pharmacopeia 36 National
Formulary 31 (United States Pharma-
copeial Convention, Rockville, Mary-
land, 2012).
(4) ISPE, Good Automated Manufactur-
ing Practice (GAMP) Guide, version
5 (International Society of Pharma-
w w w. s p e c t r o s c o p y o n l i n e . c o m November 2013 Spectroscopy 28(11) 7

ceutical Engineering, Tampa, Florida,

2008).
(5) ISPE, GAMP Good Practice Guide Val-
idation of Laboratory Computerized
Systems, 1st Edition (International
Society of Pharmaceutical Engineer-
ing, Tampa, Florida, 2005).
(6) ISPE, GAMP Good Practice Guide: A
Risk Based Validation of Laboratory
Computerized Systems, 2nd Edition
(International Society of Pharma-
ceutical Engineering, Tampa, Florida,
2012).
(7) R.D. McDowall, Spectroscopy 25(11),
2429 (2010).
(8) Current Good Manufacturing Practice
Regulations for Finished Pharma-
ceutical Goods, in 21 CFR 211.68(b)
(U.S. Government Printing Office,
Washington, DC, 2008).
(9) US Food and Drug Administration,
Guidance for Industry, General Prin-
ciples of Software Validation (FDA,
Rockville, MD, 2002).
(10) R.D. McDowall, Spectroscopy 26(12),
1417 (2012). R.D. McDowall
(11) Proposed revision to United States is the Principal of
Pharmacopeia <1058> Analytical McDowall Consulting
Instrument Qualification in United and the director of
States Pharmacopeia (United States R.D. McDowall Limited,
Pharmacopeial Convention, Rock- and the editor of the
ville, Maryland, 2013). Questions of Quality
(12) L. Schuessler, M.E. Newton, P. Smith, column for LCGC Europe, Spectroscopys
C. Burgess, and R.D. McDowall, sister magazine. Direct correspondence to:
Pharm. Tech., in press. spectroscopyedit@advanstar.com
(13) C. Burgess and R.D. McDowall, Phar-
macopeial Forum 38(1), 2012. Chris Burgess is
(14) Computer Validation Initiative Com- the Managing Director of
mittee of the Society of Quality As- Burgess Analytical Con-
surance, Computer Risk Assessment sultancy Limited, Barnard
(Society of Quality Assurance, Char- Castle, County Durham,
lottesville, Virginia, circa 1997). UK. He has over 40 years
(15) ISPE, GAMP Good Practice Guide, A experience as an analyti-
Risk Based Approach to Compliant cal chemist including 20 years working in
Electronic Records and Signatures, the pharmaceutical industry and 20 years
(International Society of Pharma- as a consultant. Chris has been appointed
ceutical Engineering, Tampa, Florida, to the United States Pharmacopoeias
2005). Council of Experts 2010 to 2015 and is
(16) R.D. McDowall, Quality Assurance a member of the USP Expert Panel on
Journal 12, 6478 (2009). Validation and Verification of Analytical
Procedures.

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