MILESTONE

H E L P I N G
C H E M I S T S

Milestone Validation Package

Service Manual
MA212
Milestone S.r.l. MA212-002 – Milestone Validation Packages guidelines

Summary
1. Introduction to Milestone Validation Packages .................................................................................... 2
2. IQ-OQ protocols ............................................................................................................................... 4
2.1. Introduction ............................................................................................................................. 4
2.2. IQ-OQ package ........................................................................................................................ 4
2.3. IQ-OQ requirements ................................................................................................................. 5
2.3.1. Site requirements .............................................................................................................. 5
2.3.2. Personnel requirements ..................................................................................................... 5
2.3.3. Tools and measurement instruments .................................................................................. 5
2.4. Clarifications about modules...................................................................................................... 6
2.4.1. Module: Pre-Requisites for IOQ .......................................................................................... 6
2.4.2. Module: Customer SOP’s Verification module ...................................................................... 6
2.4.3. Module: Major System Component Verification.................................................................... 6
2.4.6. Module: Rotors verification ................................................................................................ 8
2.4.7. Module: Microwave Radiation Leakage Verification .............................................................. 8
2.4.8. Module: Heating and digestion tests verification .................................................................. 9
2.4.9. Module: Operation and Maintenance training .................................................................... 10
2.4.10. Module: Audit Trail Verification ........................................................................................ 10
2.4.11. Module: Historical Data Verification .................................................................................. 11
2.4.12. Module A: Deviation report .............................................................................................. 11
2.4.13. Module B: Personnel involved in qualification activities ...................................................... 12
2.4.14. Module C: List of instruments used to perform the tests .................................................... 12
2.4.15. Attachments ................................................................................................................... 12
2.5. Proposal of IQ-OQ schedule .................................................................................................... 13
3. PQ guidelines ................................................................................................................................. 13
4. RQ guidelines ................................................................................................................................. 14
5. URS and DQ ................................................................................................................................... 14
6. Practical tips for compiling protocols ................................................................................................ 14
7. FAQ ............................................................................................................................................... 16
8. GLOSSARY ..................................................................................................................................... 16

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Milestone S.r.l. MA212-002 – Milestone Validation Packages guidelines

1. Introduction to Milestone Validation Packages

The Milestone Validation Packages include several protocols in order to fulfill regulatory requirements, such
as the Good Manufacturing Practice (GMP) guidelines that, along with our superior support and expertise,
will be by your side throughout the whole process. Our experts will support you with the right configuration,
with a dedicated procedure for your samples, with a demonstration of the system’s capabilities and with a
complete validation package that includes: DQ (Design Qualification), IQ (Installation Qualification), OQ
(Operational Qualification), PQ (Performance Qualification) and RQ (Re-Qualification). All the tests carried
out by our service engineers are guaranteed by certified test equipment, providing high accuracy and
meeting all the regulatory requirements.

This is achieved though the following products:

Part Number
Description
Ethos Up UltraWAVE
Milestone Validation Package
MVP001E MVP001UW
(IQ, OQ, PQ guidelines, 21CFRpart11 compliance)
Milestone Requalification Package (RQ) MVP002E MVP002UW
Milestone Design Qualification Package (DQ) MVP003E MVP003UW

For your further reference, on the following table you can find the typical timeline sequence of qualification
steps:

Before Purchase Before Use After Use

Technical
Technical
Documental Functional Validation Maintenance
specification
Validation

URS DQ IQ OQ PQ RQ

Intent of the following document is to offer basic guidelines which, together with a specific training provided
by Milestone organization, allow to successfully and efficiently propose and perform our qualification
products to customers.

• These Milestone Qualifications guidelines shall not be considered as part of the qualification documents.
• These guidelines are based and refer to revision 2 of IQ-OQ protocol.
• The mentioned qualification protocols should be applied to Milestone microwave systems equipped with
T660/1660 terminal and easyCONTROL software revision 02-D-SP2 or following.

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• The compliance to the 21 CFR part 11 regulation requirements is explicated and certified through the
related declaration attached to the Ethos Up and UltraWAVE user manuals.
In order to fully comply to those requirements, each system subject to this qualification package, in
addition to the normal setup, requires the following software settings:
Login mode: CFR password

Configuration of trail: Standard + Application

Additional files (saving formats in addition to .dpr): Bitmaps, PDFs, Samples (Excel), Run (Excel)

Save files automatically: activated and set on A:/USB stick

Add a new Users account with Manager rights

• With the exclusion of particular and limited cases below reported, no one of the original software
settings have to be modified during qualification and installation processes without preventive
authorization from Milestone.
This exclusion concerns: the local Language, the Time and Date settings, the Login mode and Users
accounts, the LAN network setup, the files saving formats and modes, the Balance setup.
The eventual modification of those settings may be also related to specific requirements and policies
from the customer. For example, because the use of USB memory sticks in the laboratory is not allowed.
• The qualification protocols shall be performed keeping the easyCONTROL set at the English language
factory setting. Eventual change of software language can be done once the qualification has been
accomplished.
• The reports of test or digestion runs performed during the following qualification activities have to be
saved on the USB memory stick or on the defined network folder, under all the file formats available and
in particular as .pdf and .xls (or .csv). Thus, when necessary the generated reports have to be printed
also on paper copy.
• To comply the 21 CFR part 11 requirements, the activation of the CFR
signature + password login mode is not required. However, if this
additional feature is requested by the customer, be sure to create and
keep always available a USB stick signed as Service login account.

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2. IQ-OQ protocols
2.1. Introduction
Before starting the qualification process, be sure that for all the time there will always be at least one person
from customer organization attending and participating in the operations. Those personnel should have the
responsibility of signing the protocols whenever required (i.e. “Reviewed by…”)

Once the qualification process is complete, please send back to Milestone a filled copy of the signed Final
approval page.

2.2. IQ-OQ package

The Milestone IQ-OQ package includes:

a dedicated folder with Milestone logo containing a paper copy of the latest IQ-OQ protocol
reporting the serial number of the involved UltraWAVE or Ethos unit
eventual attachment documents such as copies of manuals and certificates. See also related notes
on below Attachments section
a set of 10 vials prefilled with ~0.1 g of Avicel® cellulose powder with related data sheet

a “Milestone Validation Package passed" adhesive sticker:

a set including a multicolor pen and highlighter markers. Generally, for qualification purpose the
meaning of the highlighter colors:
- green or yellow = in compliance
- orange or pink = not in compliance
- blue = optional or not applicable elements

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2.3. IQ-OQ requirements

2.3.1. Site requirements
• For the accomplishment of IQOQ protocols and complete unit installation within the scheduled timing,
before to start with the sequence, it is fundamental that each requirement reported on the
Preinstallation notes has been fully fulfilled.
• The laboratory has to be equipped with all necessary Personal Protective Equipment, basic instruments
and chemicals. More in details:
labcoats, protective glasses, gloves
generic labware equipment such as beakers, acid dosing devices
deionized water, HNO3 65-67% (minimum 500ml), H2O2 30% (minimum 100ml)
an adequate quantity of transparent 50ml graduated flasks (i.e. “falcon” type flask) according to
the number of positions tested during the Heating and Digestion test
a photocopying machine
• In addition to the preinstallation requirements, if the use of the USB memory sticks is not allowed in the
laboratory, the system has to be properly and successfully connected to a LAN network before to start
with the below qualification protocol. See related instructions on User Manual.

2.3.2. Personnel requirements

2.3.2.1. Milestone representative
• The personnel in charge for the execution of one of the Milestone Validation Packages has to be
adequately trained. The customer may require to provide copy of the training qualification certificate
released by Milestone.
• We strongly recommend the personnel who will perform the qualification to deeply and carefully review
in advance this guide as well as a draft copy of the protocols.
• Some of the tests require the execution of laboratory activities. These should be performed by
customer’s personnel with laboratory operation skills but if for whatever reason this is not possible, also
those activities should be performed by the Milestone representative.

2.3.2.2. Customer
• Personnel from customer organization who attend and participate to the qualification protocols, should
report as defined in the Quality Assurance system although he may not necessarily have a Quality
Assurance function. However, the oversight from the Quality Assurance over the whole process is highly
recommended.
• Considering that some of the training requirements are discussed during the execution of other Modules
of the protocol, each qualifying User has to actively attend the whole qualification process and not to the
Operation and maintenance training Module only.

2.3.3. Tools and measurement instruments

regular tools kit (screwdrivers, spanners…)
a flexible meter for measuring the unit dimensions
an eventual stamp for a faster and clear marking of attached documents (see also below
Attachments section). Milestone can supply a such stamp under p/n 70439.
a digital camera or whatever device suitable to take pictures that, on request from customer,
may have to be then printed on paper on site through a color printer
a stapler for the eventual preparation of additional attached documents
an USB stick with Service level signature (in case generable on site before to start the
qualification)
only for UltraWAVE; a small magnet (for instance the magnet tool included in the WZ000123IT
tools kit)
microwave leak tester with following specifications: 2450Hz working frequency, 0.1mW/cm2
resolution, valid certificate of calibration
multimeter for control of supply line voltage

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2.4. Clarifications about modules

For an easier understanding of the activities that have to be done, we are here reporting some clarifications
about specific modules of the protocol.

2.4.1. Module: Pre-Requisites for IOQ

• Before starting the qualification process, the customer personnel must have reviewed and approved the
protocols on the initial “APPROVAL PAGE”. Thus, the customer should have received and reviewed these
documents some days in advance for reviewing.

2.4.2. Module: Customer SOP’s Verification module

• The preparation and release of SOP’s (Standard Operating Procedure) are in charge to customer and if
they are not ready or anyhow available at the time of qualification, the qualification/commissioning is
completed but a Deviation procedure will be issued for the related module. In that case the follow up
and managing of that deviation is fully in charge and under the responsibility of customer personnel
(QA, LM).
• The “location” field of the SOP’s verification section refers to the physical place (room, office…) where
these procedure are retained by the customer organization.
• Useful information for the preparation of SOP are available on the specific section of the Milestone User
Manuals

2.4.3. Module: Major System Component Verification

• The “D: document verification” choices can be applied when the feature which has to be proved is not
directly or indirectly demonstrable or accessible on field activities. In those cases, copy of relevant
documents like User Manual should be attached to the protocol.
As “I: visual inspection” verification mode is intended the visual confirmation of the specified feature but
also the control of the effect of the same. For instance, the installation of the sensors can also be

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confirmed through the actual signals displayed on the “Service/MWB-650/Analog” panel of the
easyCONTROL software.
• For UltraWAVE only: the serial numbers of filter, non-return valve (check valve) and optional compressor
and gas loading module, can be taken directly from the items. See reference marks on below pictures:

• For UltraWAVE only: some of the chiller specifications (e.g. cooling power) can be verified through
related user manual. Thus, a copy of the same should be attached to the protocol.

2.4.4. Module: Software Version Verification

• Detailed information about the software revision installed on the unit can be collected from the initial
login panel:

• A backup copy of the installed software is also available on the USB stick included within the Welcome
kit of the unit:

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2.4.5. Module: Critical Instruments Calibration

• According to the number of reference temperature sensors installed on the instrument, it is necessary to
attach one or more reports in order to prove the calibration of the same
• The Calibration expire date of the critical instruments used during qualification may not result from the
related calibration certification. Typically, the expiration is 12 months from the last calibration, but
according to the Quality Assurance procedures and policy this period may be different.

2.4.6. Module: Rotors verification

• The control of the eventual torque wrench is done through visual inspection and to the “click” sound at
the end of vessels closure. A copy of the torque wrench manufacturer certification can be anyhow
attached to the protocol.

2.4.7. Module: Microwave Radiation Leakage Verification

• The microwave leak test has to be performed loading 275ml ±10ml of water in a suitable beaker and
running the program from the Power test panel on the Settings section. For this purpose, the only
relevant parameter is the “Test energy” which has to be set at the maximum power range of the tested
unit:

Other parameters do not need to be considered.

• For the Calibration expiration date, see same remarks as for Module Critical Instruments Calibration.
The information about the used leakage meter and whatever other measurement instruments have to be
reported also in the List of instruments at Module C.

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2.4.8. Module: Heating and digestion tests verification

• Before starting this test, be sure that all the necessary material is available. See also the notes included
into the Site requirements section.
• In order to be considered exhaustive for its purpose, the test has to be performed on four vessels/vials
placed in opposite positions.
The exceeding Avicel® cellulose powder samples included in the validation package can be used if for a
whatever reason, the test has to be repeated.
• The rotor/rack shall be only loaded with vessels/vials filled with the digestion solution. Empty vessel/vial
positions do not have to be loaded.
• Only for UltraWAVE: if for the same rack, the system packing includes vials made by different materials
(e.g. glass and PTFE), the test can be performed indifferently using different types at the same time or
only one.
• In case the system packing includes different rotor/rack assemblies, the test can be performed
indifferently on one of them only.
• The final digestion verification for each vessel/vial shall be done together with customer personnel also
for witnessing purpose.
• Before to start the heating run, be sure that the test will be then automatically saved under all the
available Additional files formats. See the Files parameters on Settings section of the software.

• After entering the parameters reported on the method, we recommend to save the method with a new
name directly linked to the protocol. For example, “Heating and Digestion Test Module xx…”.
• Once the heating run has been executed, open the generated .pdf and .xls (or .csv) files on a PC, print
them on paper and create a new attachment to the module.
Please note that opening the .xls (or .csv) file on PC, in order to properly visualize them it could be
necessary to modify the actual Data separator settings on the PC program. Moreover, considering that
easyCONTROL software records information every two seconds of the run, be aware that the printing of
this file may require the print of some tens of pages.

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• The filling of the verification section of the module can easier be done using the data reported on the
.xls (or .csv) file as follows:

Print out of the .xls run file: IQ-OQ protocol:

* As an alternative the starting time can be collected from

…
the .pdf report generated at the end of the run

2.4.9. Module: Operation and Maintenance training

• Most of the Users training activities reported on this module can be performed while executing the other
modules. For that reason, it is important that each Users under training actively participate to those
parts of the qualification.
• The training can also be achieved through the use of documents or supports such as the User Manual
• In order to evaluate the correct understanding of the most relevant topics, the instructor shall frequently
interact with each User attending the qualification.

2.4.10. Module: Audit Trail Verification

• This and the following Modules are placed at the end of the qualification sequence so that the checks
can be done also on all the already executed activities
• The integrity of the original audit trail file is guaranteed by the impossibility to modify the same from the
easyCONTROL software and to upload back to the terminal the exported .csv copy of the same.
However customer organization should take all the precautions to protect the copied .csv file in manner
to avoid access to the same from unauthorized people. A higher level of protection can be achieved also
through the immediate printing on paper of the exported .csv trail file.

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• The verification of the “Alarms” events recorded on Trail can be done checking the presence of already
existing and recorded errors or reproducing the following anomalies:
on Ethos:
remove the PP stopper on the right side of the unit,
while running a whatever mw program, insert a pen into the hole on the cover and
slightly push on the door locking mechanism in manner to deactivate it,
check that the M111 “The door lock mechanism doesn’t work correctly…” error message
is displayed on software and then recorded under the Errors section of the trail

on UltraWAVE:
while the left side clamp is fully opened, position a small magnet near to the front
Clamps Closed position sensor
check that the A46 “Sensor error S4 and S5…” message is displayed on software and
then recorded under the Errors section of the trail:

2.4.11. Module: Historical Data Verification

The control of the automatic saving at the end of a cycle can be done also on the test run already executed
at module Heating and digestion tests verification.

2.4.12. Module A: Deviation report

When the actual results of a test step in a test protocol do not match the expected results, this is called a
Deviation.
Purpose of this module is to help the correct management of eventual deviations arisen during the
qualifications process.
Here some recommendations about Deviations are reported:
• Prepare a separate Deviation module for each deviation and attach the completed forms to the related
section

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• According to the cause of the deviation, the follow up of the same may remain in charge to the qualifier
personnel or to the customer.
• In case the deviation is originated by whatever cause directly related to the supplied unit and
accessories, please contact Milestone for the necessary support.
For other causes, for example the missing of customer’s SOP, the follow up and managing will be in
charge at who has the responsibility of the same. In that case only the “Deviation description” section of
the deviation report has to be filled and signed during qualification process.
• All deviations have to be reported on the Final qualification report.
• The original Deviation report included in the protocol does not have to be filled and it has to be
considered as ”Copy 1 of…”. Once the qualification protocol is completed according to the quantity of
eventual deviations the number of produced copies hat to be entered in the original but also on the
generated deviation reports. Only at that time it is possible to ban the original empty copy of the
deviation report module. See also related notes on following Practical tips for compiling protocols
chapter

2.4.13. Module B: Personnel involved in qualification activities

Each person who is actively participating to the qualification activities has to be listed and has to sign this
module:

2.4.14. Module C: List of instruments used to perform the tests

On this section all the measurement instruments used during the qualification are listed.

2.4.15. Attachments
• Whatever attached document (paper manuals, certificates, printed pictures…) must be clearly identified
reporting the following information:
identification number
references to the section, module or anyhow part of the protocol to which the attachment refers to
number of pages (sheets) of the attachment
initials of the person who is performing the qualification
date of qualification
• This kind of identification activities can be simplified by the use of a stamp (p/n 70439) like

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• The relevant sections or sentences of attached documents have to be highlighted with green or yellow
color marker.
• To further support the qualification performer, Milestone already includes some ready to use
attachments to the modules. Those attachments are already pre-marked with identification information
but needs to be confirmed with actual date and with the initials of the performer.

2.5. Proposal of IQ-OQ schedule

On the following table we are reporting a tentative schedule of the qualification activities so that they can be
executed in the most efficient way from a single trained person. .

• This scheduled is based on a full working day following the usual installation activities. However,
considering the customer and representative organizations, some activities such as the Users training
can be anticipated to the day before.
• To optimize the time, the recommended sequence of operations does not strictly follow the 1 to 18
sequence of modules. For instance, during the waiting time while executing the Heating and Digestion
test it is possible to complete those modules that do not require the access to the software

When What Notes

Including identification of the goods reported on

Unpacking and plugging of packing list / delivery note and of the IQ-OQ
09:00
delivered system package. If required, connection to the LAN
network through support of local IT specialist.

Brief presentation to the

The IQ-OQ protocol must be revised and
09.45 customer of qualification and
approved in advance by customer
installation schedule

10:00 Module 1 Pre-requisites for IQ-OQ

Once verified the major system operations, the

microwave sealing, it is possible to run the
equipment and execute the Heating and
10:10 Module 10 to 12
Day 1 digestion test. At that time, it is possible to
anticipate the execution of Modules 2 to 9.

12:00 Lunch break -

13:00 Module 2 to 9 Documents and major components verification

15:30 Final Training and software verifications

Modules 13 to 18

Once all protocols have been executed and

Modules A to C
Modules filled out, the final qualification section
Final Qualification Report
17:00 has to be compiled and signed by the customer.
End of the IQOQ qualification
At that point the MVP sticker can be compiled as
activities
well and then applied on the unit.

3. PQ guidelines
The Milestone PQ package includes:
a dedicated folder with Milestone logo containing a paper copy of the latest PQ protocol reporting
the serial number of the involved unit
eventual attachment documents such as manuals and certificates.
a “MVP passed" sticker

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• Since PQ have to be performed on customer’s application, Milestone provides a protocol without

specifying samples and methods. All these details have to be collected and evaluated upon discussion
with the customer.
• In any case, the selected digestion method has to be set according to Milestone user manuals and
application notes. In case of doubt please contact Milestone Application specialists in advance.

4. RQ guidelines
The Milestone RQ package includes:
a dedicated folder with Milestone logo containing a paper copy of the latest IQ-OQ protocol
reporting the serial number of the involved UltraWAVE or Ethos unit
a set of 10 vials prefilled with ~0.1 g of Avicel® cellulose powder with related data sheet:
a “MVP passed" sticker

• The Re-Qualification protocol shall be applied when one or more of the following conditions is valid:
o At the end of the scheduled periodic maintenance according to the Milestone’s preventive maintenance
prescriptions
o In case of main service activities requiring the replacement of one or more between the reference
temperature sensor component, the control terminal, the main interface board, one of the HV
components
o In case of software upgrade
• In order to prove that the maintenance or service activities have been successfully completed, before to
start performing the RQ, copy of a Service Report or Protocol shall be compiled and attached to the RQ
Pre-Requisites module.
• In case of software upgrade, the compatibility of the same with the current revision of User Manual
available at the customer site has to be verified according to the latest Milestone reference table. If a
new manual is required, then a paper or electronic copy of that revision has to be provided to the users.
• It is not necessary to execute the RQ modules (# 8 to 12) that refers to the software, in case this has
not been updated. Thus, those unused Modules can be simply banned and signed as “N.A.”
• Since the RQ protocol also includes the control of the reference temperature sensor calibration, during
the maintenance or qualifying activities a reference calibrating device has to be available on site along
with related certificates.
The control of the sensor calibration can be performed and then reported on the Calibration Control
Report form provided by Milestone.
• This RQ can be applied also on old units manufactured and already on the field before the release of this
protocol but only after verifying the requisites like the minimum software version

5. URS and DQ
As for definitions, User Requirements Specifications and Design Qualifications have to be prepared in the
preliminary steps of the supply of a new device. Milestone can support the customer by providing a general
URS form.

Starting from the URS reviewed and approved by the customer, Milestone can then supply a complete DQ
Package.

6. Practical tips for compiling protocols

• All the hand writing has to be done with indelible ink pen. Do not use pencil or ink that can be erased.
The color of the ink is not a GxP requirement but it may be a site requirement. Thus, before to start
on filling protocols it is recommended to check this and similar specifics with customer
personnel at first. Normally both blue or black color ink can be accepted.
• The hand writing shall be as much as possible clear, readable from everybody and avoiding any unclear
character or words that may cause misunderstanding or confusion.

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• The best care should be applied to avoid whatever kind of writing mistake while filling reports and
documents. Nevertheless, in case of data entry transcription errors, wrong sentences or words, they
have to be handled as follow:
o put a straight line through the incorrect entry so that it can still be readable for future reviews
(e.g. Wrong data)
o sign and date the incorrect entry
o enter the correct value
o enter a short comment about the error into the Notes or Comment section of the same page or
module. It is not required to generate a Deviation report in case of transcription error.
Errors on writing dates should be avoided at all.
Never use white ink or correction fluid to correct the entry in the records
• Data entry should be done contemporaneously with the activity. However, in exceptional cases, data can
be entered later upon clean indication of the dates and times when the activity was performed and when
is recorded. Document the explanation to substantiate the entry and the reason for the delay in
recording.
• Never use scratch papers, loose papers or “post it” to record the data.
• Time should be entered in 24:00 hour cycle. Record the time in HH:MM format. For example, 10:02 AM
should be written as 10:02 while 10:02 PM as 22:02.
• Entering information in tables, always fill a row only after all fields in the previous row have been
completed.
• Not applicable section or filling spaces such as exceeding rows on tables, lists and notes that remains
empty, once the protocol is accomplished have to be banned and marked as “N.A.” with initials and date
like on following example:

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• Whenever a qualification protocol requires the use of multiple copies of the same page and therefore
when the “Copy ____ of ____” field is available on the page, the duplicates have to be prepared before
to proceed filling. The original copy should be kept blank and then banned once the protocol is
accomplished.
• Unsigned documents or records are incomplete and should not be used to perform any task or
considered as evidence of a completed task
• Any participant to the validation process should not permit to sign by another member of staff unless
delegated. Signatures must never be forged.

7. FAQ
1. Q: Can these protocols be required and applied also on other fields different than
pharmaceutical?
A: Yes, whenever the device has to be validated and therefore whenever it is used in a GLP process
2. Q: What happen if a Deviation note is issued?
A: according to the subject and cause of the deviation, the follow up shall be done by the customer or
through the support from Milestone. See above point 2.4.12
3. Q: What happen if customer would like to apply different or additional tests to those
already reported on these protocols?
A: The performing of not required tests shall not interfere with the execution sequence of the protocols
included in the Milestone Validation Packages. The obtained test results have to be recorded on separate
reports and forms.
4. Q: Why are there so many documents?
A: Proper documentation is required to demonstrate that the system was tested, including validation
planning, protocol execution, and quality review. From a regulatory auditor’s point of view, if you do not
document what you did, you did not do it
5. Q: Am I allowed to change a validated system or protocols?
A: Changing validated systems requires Change Control to ensure that there are no unexpected or
unrecorded changes to the system.
6. Q: What is an audit trail?
A: An audit trail is an internal log in a program that records all changes to system data. This is tested by
demonstrating that all changes made to data are recorded to the audit trail.

8. GLOSSARY
DQ: Design Qualification
FAT: Factory Acceptance Testing
GCP: Good Clinical Practice, a collection of quality guidelines for clinical operations
GDP: (or GDocP) Good Documentation Practice
GLP: Good Laboratory Practice, a collection of quality guidelines for laboratory operations
GMP: Good Manufacturing Practice, a collection of quality guidelines for manufacturing operations
GxP: An abbreviation combining GCP, GLP and GMP
IQ: Installation Qualification
LM: Laboratory Manager
MVP: Milestone Validation Package
OQ: Operational Qualification
PQ: Performance Qualification
QA: Quality Assurance (customer personnel)
RQ: Re-Qualification
SAT: Site Acceptance Testing
SOP: Standard Operating Procedure
URS: User Request Specifications
VMP: Validation Master Plan
VP: Validation Plan
21CFR-part11: Title 21 Code of Federal Regulations part11

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