Validation

SITE ACCEPTANCE TESTING

& SYSTEM VALIDATION

An Overview
 Validation - What is it?
 Test your system, using a defined test method
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 Requires a Test Plan at the beginning

 Generate all Test Results for each feature
 Followed by Test Report at the end
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 Who does the testing?

- Your vendor or local users (Prod’n & QA)
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 How long does it take to validate?

- Test plan, test results creation, test report
 WHAT DO YOU VALIDATE?
 Hardware PC, balances, printers, barcode scanners, tablet-PC
Included in Installation Qualification (IQ) stage
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 Software Standard COTS packages, in house programs
Included in Operational Qualification (OQ) stage
 Interfaces (ie: between ERP/PLC and 3WS)
Included in Operational Qualification (OQ) stage
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 Other Issues (Network, backup, security)
Included in Installation Qualification (IQ) stage

Your site will repeat some, but not all, test results generation at
the Performance Qualification (PQ) stage, before you GO-LIVE
QA Approves the Validation Master Plan
 QA are the group who ‘approve’ the VMP.
They will want to see plans before testing
begins, followed by detailed test
documentation, which clearly explain how
the testing should proceed.
 After testing, the ‘approvers’ must be able
to make a judgement, that the actual
results are correct and reflect the intent of
the testing.
 3WS – an example of a computer system –
is driven by many parameters, which must be established before validation starts
So how do you separate each
component of a Validation project?
 Software testing
 Hardware installation
 Hardware testing
 Standard Operating Procedures (SOP)
 Network setup
 Interfaces (Software or Hardware?)
 Audit trail of changes to data
 Tracking changes to systems (version mgt)
 System Upgrades – how to validate
 Validation Planning. Identify which parts of the system
are Hardware, Software or other aspects, such as SOP etc
File Server setup during
SW / OQ ERP System installation of the system
HW/ IQ
Work Stations setup during
SW / OQ 3WS Dispensing
installation of the system HW/ IQ
SW / OQ PLC System PLC Installation during
installation of the new system HW / IQ
SW / OQ Audit Trail / Logging
PLC Configuration SOP
SW / OQ Software Configuration Setup hardware - balances,
printers, scanners, tablets, etc SOP
SW / OQ Write Test Scripts
System Backup, Restore,
Security, New User, New PC SOP
SOP Write SOPs on setup

VALIDATION status in relation to the VMP

Multi System Diagram
EXISTING SYSTEMS

NEW SYSTEM

Multi System Diagram – introducing ONE new system

 INSTALL HARDWARE
AND CREATE SOPs

Multi System Diagram – hardware installation

 OLD SYSTEM HAS NOT CHANGED VALIDATE NEW SYSTEM

Multi System Diagram – software validation

SOFTWARE

VALIDATION
Each Test Script has a structured format, detailing the Test No,
Description, Method to be used and Expected Results.
The bottom of the test script should be hand-written after the
test is complete: Actual Result, Tested By, Reviewed By,
numbered References and finally, a Pass or Fail status.
One DOC for each Test Result
Example Test for LOT NO
Chapter 13 Test 190 (C13T190.doc)
This test adds a New record and then confirms that the
Weight Received is not less than the Weight Approved.

To begin testing, the user creates a new DOC called

C13T190.DOC. This DOC is the Test Result and it has a
page heading, detailing the version of 3WS to be validated.
The DOC has standard quality features in the footer, such as
‘page x of y’, filename and path.

Each separate Reference within the Test is identified. Most

references are screen dumps or label / report printouts.
Each reference must also have a line of text below the screen
dump, to explain the reason for the screen dump.
Test Script Detail Chapter:13 TestNo:190
LOT NO - Add a new record

Press the NEW button

 LOT NO Detail screen

The test method requires the user to enter weight data at

Received and Approved, then press the SAVE button
Press the PRINT SCREEN button, to capture
the screen dump to the Windows clipboard
Press CTRL-V or Paste, to include the
screen dump, into the Test Result DOC.
Typical Test Result, with 4 References.
Note the line of explanation, below each screen dump.
QA must approve all Test Results
 The QA group previously approved the
plans before testing began.
 The ‘approvers’ must now be able to
make a judgement, that the actual Test
Results, are correct and reflect the intent
of the operational testing.
 They can then sign the Reviewed By
section of the Test Script.
A List of all Test Scripts,
with a check-box to
indicate when a Test is
completed, may help to
manage the overall
testing project.
HARDWARE

VALIDATION
 Hardware includes thermal printers ,
barcode scanners and electronic balances
Balance testing!

This is a negative test

against a balance.
It is a NEGATIVE
test, as it checks that a
feature DOES NOT
work, as expected.
 How to test printed hard-copy labels!
Preview the DISPENSING label

Either:
Attach printed label to
the Test Result
Or

ALL weighing information can be

Copy & Paste the label
included on the Dispensing label
display from the screen
… and the label is then printed
All 3WS labels can be viewed online before printing, if necessary.
PLC Screen dump – Windows PRT-SCN was not available,
so we used a camera, from a mobile phone! Why not?
CONFIGURATION
& SOP
ABOUT HARDWARE
 Hardware Configuration SOP

During installation, Wayahead usually help the local users,

to generate an SOP for each item of hardware used onsite.

This SOP can be used in the future, if the hardware is ever

reset back to its factory defaults, after which the hardware
may need to be re-configured, to function with 3WS.
Example SOP
for a Mettler
balance
What to include in a Hardware SOP
 Location of any User/Setup Manuals
 Are PDF copies available? Where?
 Website about supplier or installer
 Address & Contacts of supplier or installer
 Wiring diagrams
 Process – flowchart diagrams
 Etc, basically any information which will be
helpful in future years if problems occur!
 The critical
hardware
configuration
procedure is
documented
EXPANDED
Other ‘hardware’ to validate includes…

 Installation of the Operating System (ie: Windows)

 Installation of the Database (ie: Oracle, MS-SQL)
 Installation of the software.

This part of the installation and setup is considered

during the Installation Qualification (IQ) stage.
Some documents with references/screen dumps will
be generated, with explanations in various
sections, to help the ‘story-line’ for QA approval.
Network considerations
 Network Operating System
 Backup procedure
 Recovery procedure
 Adding a new PC or device
 Adding a new User
 Security policy
 etc
 Validation Planning. Identify which parts of the system
are Hardware, Software or other aspects, such as SOP etc
File Server setup during
SW / OQ ERP System installation of the system
HW/ IQ
Work Stations setup during
SW / OQ 3WS Dispensing
installation of the system HW/ IQ
SW / OQ PLC System PLC Installation during
installation of the new system HW / IQ
SW / OQ Audit Trail / Logging
PLC Configuration SOP
SW / OQ Software Configuration Setup hardware - balances,
printers, scanners, tablets, etc SOP
SW / OQ Write Test Scripts
System Backup, Restore,
Security, New User, New PC SOP
SOP Write SOPs on setup

VALIDATION status in relation to the VMP

Wayahead use a
Customer Query Form
(CQF) to detail any
onsite issues.

The CQF is created by

the user.
Wayahead use a Change
Request Form (CRF) to
manage ALL program
changes to 3WS.

The CRF is created by

the Wayahead.
 Quick Review
 Hardware requires Install, Configuration, SOPs
 Software requires install, testing, formal validation
 Future updates require an upgrade plan; which is then
approved; test the update; approve test results: go-live
 Live Systems require an audit trail of data changes and
optionally log files of activities
 Live Systems also require an history of program
version changes with explanation of each change
www.wayaheadsystems.com
John.Nesbitt@wayaheadsystems.com
Office: +61 2 9251 0066
Mobile: +61 412 565 829
Thank you.