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Design Qualification of TruScan Raman

Handheld Spectrophotometer Revision:
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1 OBJECTIVE .................................................................................................................................................... 1
2 REFERENCE MATERIAL ............................................................................................................................... 2
3 ROLES & RESPONSIBILITIES ...................................................................................................................... 2
4 PRODUCT FUNCTIONAL REQUIREMENTS FOR TRUSCAN RAMAN HANDHELD
SPECTROPHOTOMETER ...................................................................................................................................... 2
4.1 Introduction .............................................................................................................................................. 2
4.2 System Description Overview .................................................................................................................. 2
4.3 Basic Theory ............................................................................................................................................ 2
4.4 Instrument Overview ................................................................................................................................ 3
5 GMP AND ER/ES ............................................................................................................................................ 4
6 TECHNICAL REQUIREMENTS ...................................................................................................................... 4
6.1 Instrument/Basic Operational Design ...................................................................................................... 5
6.2 IT Infra structure (computer hardware, operating system) ...................................................................... 9
6.3 Application software................................................................................................................................. 9
6.4 Methods and parameters ....................................................................................................................... 10
6.5 Data collection / data entry .................................................................................................................... 11
6.6 Report .................................................................................................................................................... 12
6.7 User properties and access ................................................................................................................... 13
6.8 User account and password management ............................................................................................ 14
6.9 Data integrity / audit trail ........................................................................................................................ 15
6.10 Data backup and restore ....................................................................................................................... 18
6.11 Data transfer (export/import) ................................................................................................................. 18
6.12 Safety ..................................................................................................................................................... 18
6.13 Supplier’s quality system ....................................................................................................................... 19
6.14 Documentation requirements ................................................................................................................ 20
6.15 Service and support ............................................................................................................................... 20
6.16 Training .................................................................................................................................................. 21
6.17 Delivery and installation ......................................................................................................................... 22
6.18 Qualification services ............................................................................................................................. 23
7 DEFINITIONS ................................................................................................................................................ 24
8 MODIFICATION / CHANGE CONTROL ....................................................................................................... 25
9 APPROVALS ................................................................................................................................................ 25

1 OBJECTIVE

The objective of the document is to provide the owner of this document with the critical design qualification criteria for
TruScan Raman Handheld Spectrophotometer for design, reliability, performance and compliance. Specifications are listed
in terms of the design specification requirement, a brief summary justification for the need for the requirement and a
summary explanation of how the design specification was implemented in the product.
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2 REFERENCE MATERIAL

The reference materials used to develop the critical design qualification criteria are Ahura Scientific’s internal documents
developed during the initial design of the TruScan such as the User Requirement Document, the System Requirement
Document. These documents are archived under electronic format at an off-site secure location and area available on
demand provided that a non disclosure agreement is signed between Ahura Scientific and the demander.

3 ROLES & RESPONSIBILITIES

It’s the responsibility of QC management to insure that all the validation steps have been executed properly and that all the
documentation pertinent to the validation of the TruScan Raman Handheld Spectrophotometer are available for subsequent
inspection.

4 PRODUCT FUNCTIONAL REQUIREMENTS FOR TRUSCAN RAMAN HANDHELD

SPECTROPHOTOMETER

4.1 Introduction

The TruScan instrument is intended to simplify and secure the receiving goods control of raw materials and packaging
material at pharmaceuticals manufacturing facilities.
The raw materials above are used to produce pharmaceutical products and therefore the instrument must fulfill the
requirements of a pharmaceutical industry. The various physical forms of raw materials to be analyzed consist of:
- Solids (fine powder, micronized powder and granules)
- Liquids (high viscosity and low viscosity)
- Capsule gels (semi-finished product; oil base filled into capsule)

The Ahura Scientific TruScan Raman analyzer is designed for the non-contact analysis of active pharmaceutical ingredients
and excipients for identification purposes. The Raman analyzer is completely self-contained, operating on battery power
(small lithium ion rechargeable cell), and housed within a rugged and sealed enclosure. The unit is constructed with a
stabilized 785-nm solid-state laser source, an integrated imaging module, and a 2048-pixel diode-array-based spectrograph.
All electronics, including a single-board processor, also are fully integrated. The user interface is a simple set of push-
button controls linked to a menu-driven color liquid crystal display. A chemometrics-based spectral search package is
included that provides conclusive identification.

4.2 System Description Overview

The Raman analyzer system is designed to support process development and production of pharmaceutical products. The
system is a hand-held device and operated through a set a push buttons and configurable to operate through a PC. The
output is through the color liquid crystal display and may be communicated over a network. The Raman analyzer operates
by illuminating the materials in a container with a laser and collecting and analyzing the scattered light.

4.3 Basic Theory

Raman spectroscopy is a form of vibrational spectroscopy and as such is related to near- and mid-IR absorption
spectroscopy. Similar to the IR absorption techniques, Raman spectroscopy measures the vibrational frequencies of various
parts of a molecule. These frequencies depend on both the bond strength and mass of the bound atoms as well as other
factors such as intermolecular interactions. The 'pattern' of vibrational frequencies from a molecule is, therefore, highly
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characteristic of a given molecular species and, for solid samples, of the crystalline arrangement of those molecules. Raman
spectra may be readily recorded from gasses, liquids and solids.

While IR spectroscopy is essentially based on illuminating the sample with a broad range of wavelengths of IR light and
measuring which are absorbed, a Raman spectrum is obtained by illuminating the sample with a single wavelength of light
from a laser and collecting and analyzing the resulting scattered light. Briefly, the basic experimental arrangement to
perform Raman spectroscopy includes the following steps:

- To obtain a Raman spectrum the sample is illuminated with light from a laser.
- The molecules in the sample 'scatter' the incident laser light. Some of this scattered light contains detailed
information about the molecular properties of the sample.
- The scattered light is collected and analyzed using a Raman spectrometer to produce a Raman spectrum.
- Raman spectra are generally clear, well resolved and rich in features facilitating detailed and unambiguous
interpretation.
- The spectra contain large amounts of information about chemical composition, intra- and intermolecular
phenomena, and the longer range structure of a sample.

4.4 Instrument Overview

4.4.1 System overview

The figure below shows the TruScan instrument. The shaded box in figure 2.1 highlights the parts covered by the Product
Functional Requirement Specifications in this document (the TruScan instrument and its Syncserver application). The user
access levels Admin and Developer need access to a web browser (Internet Explorer – IE).

Detailed system component requirements are stated this Chapter.

TruScan Sync application

Instrument on server/PC

Network

Printer Archive PC/IE

Figure 4.1 Overview of the TruScan instrument.

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4.4.2 Operational process

The proposed use of the instrument is:

1. User creates and validates methods. Methods are stored in the instrument.
2. To perform ID verification, user chooses Identification method.
3. User performs ID verification of incoming goods with TruScan.
4. User connects TruScan to network for transfer of result files and reports.
5. Electronic data (result files) are stored on a network data drive for archiving and further processing (such as
signature, second review…)

Data and document created during system use:

• Instrument test data (yearly test and daily test performed by Users)
• Raw data (spectral data and calculated data in the report files)
• Reports (printed report files)

5 GMP AND ER/ES

The TruScan instrument will be used at manufacturing facilities within pharmaceutical organizations, in an area controlled
by Good Manufacturing Practice (GMP) for pharmaceutical production.

The TruScan instrument collects electronic data in GMP environment. The electronic data collected in such environment
must closely follow 21 CFR part 11 Electronic Records & Electronic Signatures (ER/ES) guidance. TruScan complies with
all the 21 CFR part 11 Electronic Records & Electronic Signatures (ER/ES) rules.
Detailed requirements on system and data security are stated in chapter 6 Technical requirements section System and
computer security.

6 TECHNICAL REQUIREMENTS

(Requirements marked with * are GMP requirements)

Operational Performance and –Basic Design

Continued next page

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6.1 Instrument/Basic Operational Design

ID Requirement description Implementation in TruScan
TruScan can identify solid and liquids with
Device must Identifies the solids and liquids raw
PASS/FAIL decision by Raman spectroscopy. The
6.1.1 materials with PASS/FAIL decision and Raman
TruScan can return some other possibilities and
Spectroscopy
their probabilities of match if the result was a FAIL.
Device must be identifying materials without The TruScan can identify materials without sample
6.1.2
sample preparation preparation
6.1.3 The system is battery powered or mains powered
via a supplied universal voltage transformer unit.
The transformer unit can use 100 – 240 V, 50 or 60
The device must be fitted to use a variety of
HZ power when mains powered or for battery
power sources.
recharging. Battery operating life is no less than 5
hours of continuous use. Battery can be swapped
very easily without tool.
6.1.4 Power Indicator. Visual indication of the battery TruScan displays the battery power level (bars) on
power must be present on the device its screen.
6.1.5 TruScan can be put to sleep during inactivity
Power-Power Savings. Device must have an
period. The sleep mode can also be triggered
inactive power mode to minimize power
automatically if the unit is not in use for a defined
consumption when not in use.
period of time.
6.1.6 Power –Low Power Warning. Device must warn TruScan battery indicator turns read when the
user when battery is running low. Subsequently, TruScan device is running out of battery. TruScan
device must be able to soft shut down will soft shut down automatically if battery is
automatically running low.
6.1.7 TruScan was tested to recover from a power hard
Power hard off. Device must be able to off. However, soft shutdowns are recommended by
successfully handle a recovery from a brutal the manufacturer. Windows CE and the TruScan
power interruption internal software architecture have been designed to
withstand a hard off .
6.1.8 Instrument is fitted with a permanently mounted
Device must be equipped with a permanently label stating supplier name, model, and serial
mounted sign or equivalent that contains: number. Power technical data details are molded-
supplier name, model and serial no and technical in to the case next to the power input connector (9
data (voltage, frequency etc). VDC, 1.5 A) (power at instrument coming from
universal voltage transformer).
6.1.9 If the instrument contains firmware, its identity
Instrument Firmware Version is available on
and version must be clear either from a label or
instrument screen for administrator access under
readable on the instrument (display or in the
Tools>Settings>Support>Ver
system).
6.1.10 Environmental noise such as Environmental Environment conditions such as neon light or sun
Light and Stray Light: Environmental light/Stray light are considered incertitude and are measured
Light must not be interferencing with automatically. TruScan adjust stray light and dark
measurement. current automatically.
6.1.11 In-house manufactured 2048 element silicon CCD
Detector
TE cooled detector
6.1.12 Device must have a Raman excitation laser TruScan’s excitation laser wavelength is 785 +/-
wavelength between 700 and 800 nm. 0.5mm, 2 cm-1linewidth.
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6.1.13 Laser is a class3B laser. Laser output is

Laser output must be less than 500 mW
approximately 350mW or lower.
6.1.14 >10,000 hrs MTBF corresponding to about
Source life must be adequate so as to not require
2,000,000 ‘runs’ or 1and ½ year of continuous laser
frequent changes.
operation MBTF
6.1.15 Device must acquire Raman Spectra in the range TruScan’s spectral range is at least 250cm-1to 2875
of at least 260cm-1 to 2800cm-1. cm-1.
6.1.16 Device must have a spectral bandwidth of Spectral bandwidth or spectral resolution is 7-10
≤15cm-1. cm-1.
6.1.17 Instrument self-test procedures are built-in to
The supplier must give suggestions for tolerance
instrument, and tolerance limits are embedded in
limits for instrument test procedures.
test procedures. These are not user-modifiable.
6.1.18 TruScan is designed to perform category IV assays
(identity tests) as detailed in USP <1225>. USP
The system must have performance <1225> indicates that the only data element
characteristics for spectrometer noise, LOD, required for category IV assay method validation is
LOQ and spectral bandwidth that meet the specificity. As such, LOD and LOQ are not
acceptance criteria for USP 1120 Raman relevant. Additionally, spectral bandwidth and
qualification protocol and USP 1220 for spectrometer noise are not settable/alterable on
validation of analytical methods. TruScan, so it is Ahura Scientific’s interpretation
that the DQ and method validation will be sufficient
to demonstrate sufficiency for the intended use.
6.1.19 Device must be supplied with a statement
TruScan is fully handheld and fully portable. It
referring to the capability of being moved about
weighs less than 3 pounds. The TruScan enclosure
to make measurements in various localities
form factor measures 12.5 x 5.88 x 3.14 in. It can be
without detrimental effects to performance.
used in any orientation and moved around to be
Device must withstand shock and vibration
used at the point of need. The instrument has been
caused during mobilization and analyzing
designed for field usage and is not susceptible to
activity to maintain accuracy and reproducibility
vibration, temperature and shocks.
of results
6.1.20 Device must read material bar codes used at
pharmaceuticals facilities and insert that Code 39, code 93, code 128, EAN-13, UPC-A,
information into the data file and the result interleaved 2 of 5 are supported by TruScan
report.
6.1.21 Device must be CE Rating TruScan is CE rated
6.1.22 TruScan is supplied with a nose cone shield that
assists in positioning materials for point and shoot
analysis. TruScan can be used with this accessory to
Device must be supplied with suitable
test solids, liquids and powders. The separate
accessories for measuring solids, powders and
purchase of a vial holder and tablet holder facilitate
liquids
the testing of chemicals in these forms. TruScan can
analyze materials through clear vial, amber vials,
plastic double bags and other transparent containers.
6.1.23 The device must be able to be cleaned with no
detectable damage with the following cleaning Ethanol, 5% bleach and detergent are perfectly
agents: Ethanol; 1% detergent, 5% bleach acceptable cleaning agents for the TruScan unit.
aqueous solution
6.1.24 The device must minimize the risk of cross- Plastic sleeves for TruScan are available to prevent
contamination cross-contamination
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6.1.25 TruScan complies with the requirements of

USP<1120> Raman spectroscopy and its reference
to NIST and ASTM as they pertain to identity
testing (qualitative analysis; note that significant
portions of <1120> only apply to a quantitative
analysis).
Pursuant to the guidance in the ISPE/AAPS/FDA
document “Qualification of analytical instruments
for the use in pharmaceutical industry: A Scientific
Approach”(AAPS PharmSciTech Vol 5, art
Device must meet USP, NIST and ASTM 22(2004)) and the new USP general chapter <1058>
requirements for compliance and be supplied Analytical instrument qualification (USP 31-NF
with: 26First supplement) the TruScan uses the preferred
Primary wavelength accuracy (x axis) calibration holistic evaluation in its ”test function” which tests
check and standards traceable to a national all TruScan subsystems in concert to assure that the
standards. instrument is operating in a manner consistent with
Raman laser wavelength accuracy calibration its intended use for material identity testing. This
check and standards holistic evaluation encompasses 12.1,12.2 and 12.3.
Signal level(y axis) calibration checks and This test is conducted using a polystyrene rod (or
standards traceable to national standard. acetaminophen, benzonitrile, acetaminophen,
cyclohexane: ASTME1840 materials) provided by
Ahura as part of its standard offering. All references
come with a certificate of analysis.
If desired, the user can set up additional methods
using ASTM E1840 materials and/or their own site
materials for the purposes of PQ and/or system
suitability testing.
Detailed statements of compliance with US<1120>,
EP 2.2.48 and 21 CFR part 11 are available as
supporting documentation.
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6.1.26 TruScan does not need to be recalibrated on a

regular basis. TruScan is calibrated at the factory
directly in accordance with ASTM E1840-96
(2002). Cyclohexane, acetonitrile, and toluene
bands are used to define the x-axis calibration of the
system, and this calibration is subsequently verified
with cyclohexane, acetonitrile, toluene,
acetaminophen (4-acetomidophenol), and
polystyrene. (All five (5) of these materials are
recommended in ASTM E1840-96 (2002)). The
laser is also directly calibrated to zero (0)
wavenumbers at this time, and continuously
monitored thereafter with automated compensation
in software.
The procedure using atomic emission lamps is
common for laboratory spectrometers with tunable
gratings and lasers (for convenient field realignment
and calibration). TruScan’s spectrometer
User must be able to perform calibration of the components are fixed-in-place and hermetically
device sealed and can not be field adjusted. A neon atomic
lamp internal to TruScan is simply used to monitor
the calibration in the context of intended use for ID
testing. This function is performed as part of the
“Test” system suitability function on TruScan. A
performance test can be executed to verify and
certify the performance of the TruScan. Protocols
and Standards kit are available.
TruScan is not designed for quantitative analysis.
To enable method transfer between instruments
TruScan is calibrated at the factory using an
externally-placed white light source in full
accordance with ‘method A’ in <1120>.
Furthermore, TruScan is not a laboratory
instrument. TruScan includes a “Test” function that
employs an external polystyrene sample to evaluate
system suitability at the standard point of sampling.
Performance qualification (PQ) regimes may, at the
customer’s discretion, use additional samples.
6.1.27 There is no prompt. Before each run, a system
Device must prompt for preliminary System
check is automatically performed to insure reliable
Suitability checks before use.
data.
6.1.28 Device must be able to be used by non-scientific TruScan’s embedded workflow software ensures
operators such that the operator is taken through the correct standard operating procedure or method
a device controlled measurement sequence is followed for each sample.
6.1.29 Software applications must be configurable in
The software is not configurable in regard to
regard to acceptance limits for Pass/Fail
acceptance limits Pass/Fail recognition.
recognition
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6.2 IT Infra structure (computer hardware, operating system)

ID Requirement description Implementation in TruScan
6.2.1 TruScan can be networked to a computer through a
Handheld device must allow secured cross0ver cable or through a LAN using TCP/IP
communication with PC/server directly or protocol. TCP/IP protocol ensures the integrity of
through a LAN the data and a fail-proof connection. Data generated
on TruScan can be transferred to a PC or a server.
6.2.2 Sync application has been tested on computers with
The Transfer application must work on
Windows XP Professional installed and Windows
computers with operating systems Windows
2000 as well as Vista. It is anticipated that it will
2000, Windows Vista or Windows XP.
also work on windows 7.
6.2.3 Ahura Scientific has run the Sync server software
It must be possible to use Antivirus program
on computers with Symantec (Norton) Antivirus
on the PC/server where the Transfer
Version 10 installed and no problems have been
application is installed.
encountered.
6.2.4 It is anticipated that Sync will remain compatible
with future Symantec (Norton) Antivirus products,
Device must permit the upgrade and update or that Ahura will issue a new version of Sync that
of the antivirus program. is compatible with new releases of Symantec
Antivirus products, but without knowledge of future
functionality an absolute guarantee cannot be given.

6.3 Application software

ID Requirement description Implementation in TruScan
6.3.1 TruScan software is self contained, and does not
Optional. User properties within the have a facility to interrogate corporate user group
application software should be connected to database, therefore it cannot access details of
the global user groups in the Corporate individual users or user groups, and cannot use
network. those details to configure TruScan user identities
and access privileges.
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6.4 Methods and parameters

ID Requirement description Implementation in TruScan
6.4.1 Device must have a storage capacity to store TruScan has a 1GB storage capacity to store
identification methods methods and scans.
6.4.2 * It must be possible to protect / lock methods. Access to methods is permitted only to users with
Developer and Administrator access privileges,
under password protection. There is no separate
password-controlled lock for each method. All
modifications of methods are recorded, together
with identification of modifying user, in the audit
trail.
6.4.3 * Optional. It should be possible to enter a
Not possible at present. Note that a method history
comment when changing methods or
can be stored as an html file in the method folder.
parameters.
6.4.4 * The audit log records that the method has changed,
but not what was changed in the method. Method
The system must create a new version of the
information is captured elsewhere:
method (parameter set) when it is changed;
Every time a method or self-test is run, a full
alternatively log the change in an audit trail
electronic record is created with a snapshot of all of
(event log).
the relevant information, including the complete
method information.
6.4.5 * It must be possible to print a summary of the Method summary is available at the Method
method elements and parameters. Management page in the WebAdmin program.
6.4.6 * Instrument connection icon on TruScan screen turns
The device must give a warning for and report
red when attempting to sync but failing to connect
of communication problems identified during
to SyncServer. Sync Error screen reports connection
sync process.
failure and type (e.g. no host detected).
6.4.7 Sync filenames are configurable (by Administrator)
Optional. Naming of files should be to include fields:
configurable to contain information on: • SampleID
• Sample ID • Barcode
• Barcode • Method Name
• Method name • User
• User • Unit Serial No. (always included)
to facilitate searching and sorting of result • Pass/Fail
files. Administrator can also specify which field will
form the first part of the filename.
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6.5 Data collection / data entry

ID Requirement description Implementation in TruScan
6.5.1 * The system must insure that data generated by Identity of user, instrument serial number, and
the device can be traced to its source (identity software version are embedded in all run and test
of user, instrument, and software). data files.
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6.6 Report
ID Requirement description Implementation in TruScan
6.6.1 * Reports must be printable.
The following must be clearly indicated on Reports are stored in .pdf and .jpg file formats, both
every printed page: of which are printable.
Reports include Device serial number, date of
• Instrument identity,
measurement, time of measurement, user identity.
• Page number and total no of pages,
All reports are single page reports, and do not have
• Date and time of measurement
a page number.
• User identity.
6.6.2 * The report must contain identifier, for
example Sample ID; to ensure that report can All reports include Sample ID
be traced to its sample.
6.6.3 Reports include:
Method name
Raw data (spectrum and reference spectrum as
overlaid figures
Result (PASS or FAIL).
Audit trail data in report includes:
User name
User login date and time

Instrument serial number

Instrument software version
Reports must contain: Instrument last self-test date and time
• Method name Instrument last self-test result (PASS or FAIL)
• Raw data (spectrum as a figure) Instrument warnings in force
• Results
• Audit Trail (AT) for the above data. Method name

Run label
Run calibration test result
Run CCD check result
Run laser power check result
Run date and time
Sample ID

P value
Result (PASS or FAIL)
User note
6.6.4 * The instrumented must log data (time, event,
Data is logged (to report and audit log) on
and user) automatically for every step in a
completion of the measurement.
measurement.
6.6.5 Administrator cannot modify report templates.
Optional. An administrator should be able to Administrator can specify which file formats will be
create, change or remove report templates. stored on Sync (Ahura binary format (.ASO)
compulsory; .pdf, .jpg, .txt. .spc are optional).
6.6.6 * Users must not be allowed to change report User access privilege level cannot modify report
templates. templates.
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System and computer security

(Requirements marked with * are GMP requirements)

6.7 User properties and access

ID Requirement description Implementation in TruScan
6.7.1 * 3 user access levels exist:
Administrator
Tiered User access with password must ensure
Developer
that only duly authorized user can have access
User
to the device. The different access levels must
All authorized users must be allocated to one of
insure that method development/modification
these levels. Administrator has access to all the
and device settings are restricted to select
functionalities of TruScan, Developer has access to
groups.
method development functionalities and user has
access to run functionalities.
6.7.2 * The administrator can view and print a summary of
Optional. It should be possible to show
unit users and their access levels from the Web
access levels and their configurations (what
Administration (WebAdmin) interface. Access
permissions are connected to each access
levels and their configurations are detailed in the
level) in the system and on a printout.
User Manual, section 4 Menus.
6.7.3 * User authorization must be checked both User name and password checks control direct
when logging directly in the instrument and access to the instrument and access via the
when using the web interface. WebAdmin interface.
6.7.4 * Standard setting for computer shall fulfill the
Screen saver on computer must be password
requirement. Computer setting should be set up by
protected.
IT personnel of the purchasing organization
6.7.5 * Standard setting for computer shall fulfill the
Computer screen saver must be activated after
requirement. Computer setting should be set up by
10 minutes of user inactivity.
IT personnel of the purchasing organization
6.7.6 * An Administrator can configure the unit to require a
The instrument must have a configurable
new login after a settable inactivity time of 5 to 30
inactivation setting.
minutes.
6.7.7 * Standard setting for computer shall fulfill the
The computer screen saver must have a
requirement. Computer setting should be set up by
function for manual activation.
IT personnel of the purchasing organization
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6.8 User account and password management

ID Requirement description Implementation in TruScan
6.8.1 * Users must be configured in the application Identical names cannot be simultaneously active on
with unique names. the instrument.
6.8.2 * An Administrator can Inactivate or Delete a user
It must not be possible to delete users, only to
from the system (an action which is audited in the
inactivate them.
system logs).
6.8.3 * TruScan does not impose a limitation on user
password validity time. The establishment of and
The system security function should give adherence to such controls should be assured by
possibility to configure security principles for external measures.
users. TruScan does not impose a minimum password
The following settings should be configurable: length. The establishment of and adherence to such
• Password validity time (recommended is controls should be assured by external measures.
3 months). TruScan does not record previously used
• Minimum password length passwords. The establishment of and adherence to
(recommended is 6 characters). such controls should be assured by external
• Number of passwords remembered in measures.
password history per user (recommended is Administrator can set the number of failed
5). password attempts permitted before locking access
• Number of failed password entries until to the instrument. Administrator can specify that,
locking (recommended is 3). once locked, unlocking is by manual action of the
administrator, or by automatic release of lock after a
period of time configured by an Administrator.
6.8.4 * Users must be permitted to change their own Users can change their own passwords on the
passwords. instrument without Administrator intervention.
6.8.5 * It must be possible to print a list of current Administrator can print a User Summary report
users. from the WebAdmin interface.
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6.9 Data integrity / audit trail

ID Requirement description Implementation in TruScan
6.9.1 * Data cannot be overwritten. If data storage capacity
The system must secure that data cannot be
is full, instrument will refuse to make further
overwritten.
measurements.
6.9.2 * TruScan automatically generates audit trails.
Electronic records cannot be changed once created.

The device must ensure that data is securely TruScan also maintains a system configuration
stored to prevent any tempering deleting or audit trail that documents changes made to the
overwriting attempt. Every change to methods system configuration by developers and
should be managed through version handling administrators.
or an audit trail.
Audit trails are delivered to a secure location
(identified by the system administrator in the device
configuration) for permanent storage.
6.9.3 * System administrator cannot change raw data or
The system administrator must not be able to
reports on the system.
change or delete electronic records (raw data,
All changes to configuration (users, methods,
reports etc) without this being automatically
settings, etc) are recorded in audit log with user,
traced to the individual.
date-time details.
6.9.4 * The system clock function of the instrument
that registers time in event logs (for example
Administrator can change system clock function.
access log, audit trail) must not be changeable
by any user.
6.9.5 The unit uses the following date format:
The system clock function must use Windows mm/dd/yyyy hh:mm pm or dd-mmm-yyyy hh:mm
standard format for date and time.
 SOP ID:
Design Qualification of TruScan Raman
Handheld Spectrophotometer Revision:
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6.9.6 * The unit records in an audit log that the following

events occurred, when they occurred (date and time)
and who initiated the event:

USER EVENTS:
User lock-out
Successful unit login
Failed unit login
Unit logoff
successful web login
failed web login
web log off
user password change
user modified (any modification)
user added
user delete

SIGNATURE EVENTS
The system must automatically register/log
active signatures import
events in an audit trail, when the user creates,
active signatures export
changes or deletes Electronic Records (raw
active signature add
data, reports etc).
active signature rename
active signature delete
active signature rename

METHOD EVENTS
method added
method modified (any modification)
method run
method delete

OTHER:
configuration import
configuration modified
note list modified
self-test run

It is not possible to delete raw data, reports, or audit

logs on the system.
6.9.7 * Not applicable. Raw data, reports and audit logs
cannot be changed or deleted by users on the
The system should make possible for the user
system. They can be transferred to a location
to enter a reason for change/delete of ER.
specified by the administrator during the
synchronization process.
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6.9.8 * Audit trail should have at least the following Audit trail includes:
contents: Identity of user who performed activity to create,
change, or delete information.
• Identity of user who performed activity to
Date and time of creation, change or deletion of
create, change or delete information.
information.
• Date and time when this happened.
The category of the information created, changed or
• The event that created changed or deleted
deleted (e.g., Method, User, Configuration setting).
the information.
It is not currently possible to record a reason for the
• The reason for the change. change.
6.9.9 * Between Syncs, new events are appended at the end
of the audit log file, and do not overwrite previously
registered events.
New events must not overwrite previously During Sync, after confirmation of successful
registered events in the audit trail. transfer of the existing audit log file to the secure
archive, the existing Sync file is erased and a new
audit log file is created which will be used until the
next Sync.
6.9.10 * No shutoff of audit trail function must be
Audit trail function cannot be switched off.
possible when the system in use.
6.9.11 * It must not be possible for a user to change or The audit log file cannot be amended or deleted in
delete audit trail or parts thereof. the system.
6.9.12 The audit log file is not accessible to users on the
Audit trail should be searchable for records, system. Once transferred to the secure archive, the
users, date, time and for type of event. audit log file is a text file that can be searched using
a text editor.
6.9.13 * Audit trail must be retrievable in electronic The audit log file is an electronic file that can be
form as well as in paper printout. printed once accessed from the secure archive.
 SOP ID:
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Handheld Spectrophotometer Revision:
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6.10 Data backup and restore

ID Requirement description Implementation in TruScan
6.10.1 * Electronic data and reports must be copied to User’s organization must have plan for backing up
another physical storage unit with “X” data and this plan must be followed the drives and
equaling number of days interval. servers containing the data related to TruScan.
6.10.2 * Electronic data and reports must be User’s organization must restore data to network
restorable with full integrity from another drives when necessary using the backup plan in
physical storage unit. place.

6.11 Data transfer (export/import)

ID Requirement description Implementation in TruScan
6.11.1 The system must be able to create and store Electronic data and reports can be stored in Ahura
electronic data and reports in the following proprietary binary format (.ASO), and in JPEG,
formats: JPEG, PDF, TXT and SPC. PDF, TXT, and SPC formats.
6.11.2 PDF files should be readable with Adobe PDF files are readable with Adobe Acrobat Reader
Acrobat Reader version 7.01. version 7.01
6.11.3 The TruScan creates electronic records in TXT and
The system should allow further integration
PDF formats. These formats can be exploited by a
of the data file into a LIMS system
LIMS system.

SHE
(Requirements marked with * are GMP requirements)

6.12 Safety
ID Requirement description Implementation in TruScan
6.12.1 The TruScan instrument, mains power and battery
charging transformers, and the battery charging
holder are all CE marked. The instrument is also
All instrument components must be CE
UL913 certified.
marked and UL certified
It is also UL61010-1 and CSA C22.2 No. 61020-2,
EN 616010-1:03/93 +A2:07/95, FDA CDRH
1040.1 certified.
6.12.2 The instrument has a warning label stating that it is
The instrument must have a suitable warning
a CLASS 3B LASER PRODUCT. It also has
label for laser radiation.
generic laser warning labels near the aperture.
 SOP ID:
Design Qualification of TruScan Raman
Handheld Spectrophotometer Revision:
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Requirements for supplier and delivery

(Requirements marked with * are GMP requirements)

6.13 Supplier’s quality system

ID Requirement description Implementation in TruScan
6.13.1 * Certification and documents describing the quality
system used for development of the system are
available for inspection at the Wilmington,
The supplier must upon request be able to show Massachusetts, USA headquarters of Ahura
certification and/or documents to describe which Scientific. Completion of appropriate
quality system that is used for development of the confidentiality and non-disclosure agreements may
system (instrument, hardware and software). be necessary for access to these documents. Ahura
Scientific is also ISO certified. Registrar for the ISO
certification is NSAI. ISO certificate has a date of
June 17 2009.
6.13.2 * Ahura Scientific has a version control system in
The supplier must have a system for version
place for control of documents supporting the
handling of documents supporting the system.
system.
6.13.3 * Ahura Scientific can supply statements that the
software source code is available for review by the
The supplier must have documented statements
purchasing organization or inspecting authorities
that the application software source code is
(for example FDA, MPA) at the Wilmington,
available for review by the purchasing
Massachusetts, USA headquarters of Ahura
organization or by Purchasing organization’s
Scientific. Completion of appropriate
inspecting authority (for example FDA, MPA).
confidentiality and non-disclosure agreements may
be necessary for access to these documents.
6.13.4 * Training for all personnel is documented in training
The supplier should have documented records of
records. Education and experience are documented
training and experience for its software
in resumes (CV) for all employees, including
developers.
software developers.
6.13.5 * The supplier should have documented records (for
All training records for Ahura Scientific personnel
example copy of certificate) of training and
are on file in the human resources department of
experience for any service personnel performing
Ahura Scientific.
work at Purchasing Organization.
 SOP ID:
Design Qualification of TruScan Raman
Handheld Spectrophotometer Revision:
Issue date:
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6.14 Documentation requirements

ID Requirement description Implementation in TruScan
6.14.1 * A User Manual is supplied with the system which
describes how to carry out:
Technical documentation must be delivered with Instrument tests
the system. It should give foundation for Maintenance
procedures regarding: System configuration and administration.
• Calibration/instrument tests and maintenance
• System configuration and administration. A one–time calibration is carried out at the factory.
No further calibration of the device is needed during
its useful life.
6.14.2 * The supplier must have a description of electronic The User Manual describes the run reports and
records (ER) that the system creates, handles and other records that TruScan creates, handles and
stores. stores.
6.14.3 * Manuals for the use and maintenance of the
A User Manual is supplied with the system which
instrument must be a part of the delivery. One
describes the use and maintenance of the system.
manual per instrument.
6.14.4 Documentation must be delivered in both paper
The User Manual is delivered in electronic format
and electronic format. One set of documents in
and paper format.
paper format per instrument.
6.14.5 Documents in electronic format must be delivered Documents in electronic format are delivered as
as PDF files alternatively in Word (DOC) format. PDF files.

6.15 Service and support

ID Requirement description Implementation in TruScan
6.15.1 * There are no routine service or maintenance
Documentation on which parts of the instrument
requirements for the instrument. An annual system
needs service and how often must be delivered
evaluation and recertification of performance is
with the system.
available.
6.15.2 The supplier must present a service agreement
A Service Contract is available on request, at
where checkpoints and service frequency are
additional cost. Tiered level services are available.
specified.
6.15.3 Ahura Scientific provides an internet and telephone
The supplier must have a support function.
based support function.
6.15.4 Ahura Scientific provides 24 hour, 365 days per
The supplier should have telephone support during year telephone support, free for the first 12 months,
purchasing organization’s office hours. and as part of the service contract beyond 12
months.
6.15.5 Optional. The supplier should have telephone
See above.
support 24 hours a day, 7 days a week.
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6.15.6 Issues are captured, updated and resolved via a web

based issue tracking tool. Customer profiles are
maintained in a database associated with the issue
tracking tool. Customers support manager call
The supplier must have a procedure in place to
customers on ALL reported issues to determine the
address problems reported by the purchasing
level of support provided, timeliness of issue
organization.
resolution, etc…
Software Patches and upgrades will be announced
to the purchasing organization by email and/or
regular mail.
6.15.7 Ahura Scientific will guarantee that service and
The supplier should guarantee that service and
support packages purchased by the purchasing
support is available, even if the agency is
organization will remain available for the entire
transferred to another supplier, for at least 5 years
coverage duration even if the agency is transferred
from delivery.
to another supplier.
6.15.8 There will be at least one year warranty that covers
TruScan is supplied with 12 months warranty.
the function of delivered goods.
6.15.9 The TruScan will be supported for a minimum of 5
The instrument must be supported for an extended
years after the last sale. Parts will be available
period of time
during this time period.

6.16 Training
ID Requirement description Implementation in TruScan
6.16.1 * A basic training on the instrument and the Instrument training on-site is available upon
application must be a part of the delivery. purchase of the instrument.
6.16.2 * Instructions in setting up and administration of Instructions and training in setting up an
user groups for access control in the system must administering user access control is included in the
be a part of the delivery. IQOQ purchase and is performed during the visit.
6.16.3 Training must be performed at the latest one
Training will be provided within one month of
month after approved delivery or at an agreed
approved delivery date or at a mutually agreed time.
time.
6.16.4 All training must take place on-site at
Training will take place at on site.
The purchasing organization manufacturing sites.
6.16.5 * The supplier should give a certificate or equivalent A Certificate of Completed Training will be
of accomplished training to each participant. provided to each trained person.
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Handheld Spectrophotometer Revision:
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6.17 Delivery and installation

ID Requirement description Implementation in TruScan
6.17.1 The instrument will be delivered in suitable
The instrument must have suitable packaging or in
packaging to avoid damage and moisture during
other ways be protected from damage and
transport. The instrument is delivered in a “Storm”
moisture during transport.
Case.
6.17.2 The supplier is responsible for delivery of
Ahura Scientific is responsible for delivery of the
instrument and application with associated
instrument and associated software licenses.
software licenses.
6.17.3 Necessary communication cards and cables for All communication cards and cables necessary for
access and control of the instrument must be part access to and control of the instrument will be
of the delivery. supplied as part of the delivery.
6.17.4 The supplier is responsible for performing the
Ahura Scientific will perform the installation at a
installation. Installation should be performed at an
mutually agreed date and time.
agreed time and date.
6.17.5 The supplier should give time and date for the Ahura Scientific will notify the purchasing
delivery in an advance notice. Installation should organization of the date of delivery in an advance
be started at the latest 30 days after delivery or at notice. Installation will be started within 30 days of
an agreed time and date. delivery or at a mutually agreed time and date.
6.17.6 * The installation must be performed according to a The installation will be performed according to a
documented installations procedure that has been documented installation procedure that will be
approved by the purchasing organization in approved in advance by the purchasing
advance. organization.
 SOP ID:
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Handheld Spectrophotometer Revision:
Issue date:
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6.18 Qualification services

ID Requirement description Implementation in TruScan
6.18.1 The supplier should offer services for installation Ahura Scientific offers services for Installation
qualification (IQ) and operational qualification Qualification and Operational Qualification
(OQ) according to documented procedures. (IQ/OQ), according to documented procedures.
6.18.2 At the purchasing organization’s request, Ahura
Scientific will supply a copy of the documented
procedures for IQ/OQ in advance. The purchasing
organization can propose changes or additions to
the procedures for consideration by Ahura Scientific
It should be possible for the purchasing
but we request that the requested changes be
organization to require changes or additions to the
submitted 5 business days prior to scheduled on-site
supplier’s qualification documents (IQ/OQ).
execution so that we have adequate time to review
the changes, file internal documentation, and plan
accordingly. Significant changes to the TruScan
IQ/OQ protocol may necessitate incremental
charges.
6.18.3 The qualification procedure (IQ/OQ) should be The IQ/OQ procedures will be appropriate for the
adapted to the system configuration. particular configuration supplied.
6.18.4 * At the purchasing organization’s request, Ahura
It must be possible for the purchasing organization
Scientific will supply a copy of the documented
to approve the Supplier’s final qualification
procedures for IQ/OQ for approval by the
documents (IQ/OQ) before qualification of the
purchasing organization’s before qualification of
system is started.
the system is started.
6.18.5 The acceptance criteria of the supplier for The system will pass Ahura Scientific’s IQ/OQ
qualification (IQ/OQ) of the system should be qualification procedure before installation will be
fulfilled before approval of the delivery. deemed to be complete.
 SOP ID:
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Handheld Spectrophotometer Revision:
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7 DEFINITIONS

User/analyst
User is a person using the system. Examples of users are analysts, service and maintenance personnel and administrators.

Audit Trail
A secure, date and time stamped record, which enables reconstruction of course of events for who has created, changed or
deleted an ER and when that has happened. When required, by GxP and/or current SOP, the reason for change should also
be clear.

Electronic Record (ER)

All combinations of text, graphics, data, sound, image or other digitally represented information that has been created
changed, managed, archived, reproduced or distributed in a computerized system.

Hotfix
Something that corrects or fixes an error or a defect in a software or hardware, for example a patch.

Instrument
TruScan.

IT Infrastructure
Hardware and software components that the application is dependent upon to function. Infrastructure includes computer
hardware, servers, network, operating system or other embedded software that the specific application uses or builds on.

Template
A file used to create reports from the measurements performed by the instrument.

Mandatory requirements
Requirements by GMP or requirements critical for operation, which directly or indirectly influence the system function or
fulfillment of regulatory requirements.

Report
Printout of an analysis can be for example:
• text,
• an image,
• a spectrum.

Record
Information created, received and managed by an organization. Records are used as evidence and information for the
organization's business and/or to fulfill legal obligations.
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Raw data/Data
All original records (or verified exact copies of these) that are the result of original observations, measurements and
activities. Data collection of spectra and calculated data and result files that are created.

Sync application
The application installed on a PC or server. The application transfers data from the instrument and places them on a
network drive.

System
The system consists of the TruScan instrument and the sync application. The PC/server is not part of the system but is used
both for installation of the sync application and for administrative tasks such as for example user access administration. The
administrative tasks are managed using a web browser.

8 MODIFICATION / CHANGE CONTROL

Any changes or modification to this document must be documented and approved. The likely impact of the change of the
status of the protocol should be evaluated, reviewed, approved and training of those responsible for its execution prior to
implementation.

9 APPROVALS

Written/Revised By: Date:

Name / Department DD-MMM-YYYY
Frederic Prulliere/Product Management
Reviewed By: Date:
Name / Department DD-MMM-YYYY

Reviewed By: Date:

Name / Department DD-MMM-YYYY

Approved By: Date:

Name / Department DD-MMM-YYYY