Empower 3 Enterprise or Workgroup Software For Servers

EMPOWER 3 ENTERPRISE SOP: TMP Code Version Review date: Copy Page
OR WORKGROUP SOFTWARE FOR IT/O/027 IT/V/INS/001 No.: 01 3/2024 No.: 1/52

SERVERS
EMPOWER 3 ENTERPRISE OR WORKGROUP SOFTWARE FOR SERVERS
1. Validation Report Introduction

1.1. Objective
The Purpose of this document is to check/perform the Computer System validation of the
EMPOWER 3 ENTERPRISE OR WORKGROUP SOFTWARE FOR SERVERS
complete any validation Requirements according to the Equipment Management System
Validation Procedure.
The supplier made the validation documents prospectively. But these revalidation activities will
be retrospectively.
1.2. Scope
The documents fulfill the validation requirements for the EMPOWER 3 ENTERPRISE OR
WORKGROUP SOFTWARE FOR SERVERS
1.3. Assumptions and Limitations

The technical qualification tests which have been done by the supplier will not be repeated, but
the security and validation maintenance activities should be repeated or re-challenged.
1.4. Authority
This document has been produced by the computer system validation team which include {Q.A.
QC and I.T} representatives.
1.5. Approvals
Sector Representative Name Position Sign/Date
Tamer Awad IT Software Quality Senior
Ahmed Alsayed IT Manager
I.T. Mohamed AbdElrahman CIO Pharco Corporation
Ahmed Mokhtar IT Lead
Ahmed El saharty Q.A Lead
Q.A.
Mohamed Eltoukhy Q.A Manager
Q.C. Hazem Ahmed Madian Senior Analyst
1.6. How to use this document?

This document is divided into multiple parts each part represents validation step so each part has
to be completed and approved separately according to the validation step requirements.
1.6.1 System Overview
1.6.2 System Requirement Specification: for the Analytical Equipment and Production
Control Systems computer system requirements is related to the hardware capabilities so
these requirements have been covered by the supplier but the security requirements must be
found here.
1.6.3 Function Specifications: for the Analytical Equipment and Production Control Systems
computer system functions is related to the hardware capabilities so these functions have
been covered by the supplier but the security, Access control and audit trail functions must
be specified.
SOP: TMP Code Version Review date: Copy Page
HPLC 1200-I USING EMPOWER 3 IT/O/02 IT/VINS/001 No.: 01 3/2024 No.: 2/52
ENTERPRISE 7
1.6.4 Supplier Assessment:

Assess the supplier and product from internet feedback and previous experience with the
supplier for GAMP3 Software category since supplier audit is not required for this type of
software system.
1.6.5 Risk Assessment:
The Risk Assessment for the system requirements have to be done specially for the security,
access control and audit trail so if any of them is required or not.
1.6.6 Traceability matrix:
List the tests required controlling the system risks.
1.6.7 Operation Qualification:
Challenge the required tests with test data (SAT) System Acceptance Test for the technical
tests if it done by the supplier it will not repeated.
1.6.8 Performance Qualifications:
Another challenge for the system using actual data (UAT) User Acceptance Test for the
technical tests if it done by the supplier it will not be repeated.
1.6.9 Maintaining the validation Status:
Check the requirements to keep the system valid like {Backup, User Procedure, Training,
and Change Management. Etc.}.
1.6.10 Final Validation Report:
This paper summarizes all the validation requirements status so approving this document
guarantee that the computer system validation has been done all the system validation steps.
Done By Position/Title Signature Date

Hazem Ahmed Madian Senior Analyst
Checked By Position/Title Signature Date
ENTERPRISE 7
1.7. Introduction to the objective System
Department QC
Section Central Lab
Facility General & Penciling
System Identification HPLC EMPOWER 3 ENTERPRISE SYSTEM
Equipment Name HPLC 1200-I
Equipment Used For Liquid Chromatography Chemical Analysis
Tamer Awad
Validation Team representatives Ahmed Alsayed
(the validation team names where Mohamed AbdElrahman
the device or system is located) Ahmed El saharty
Ahmed Mokhtar
System Description in Brief control the HPLC instrument
Validation Start Date 03/2021
Validation End Date 03/2021
ENTERPRISE 7
2. System Overview
Machine/Device (Hardware Specification)

Machine Name HPLC 1200- I
Country of Origin U.S.A
Vendor Elmehy
Model 1200
Serial No. DE64260194
Device Type (GxP /non- GxP) GxP
Hardware IQ Exist Exist
Hardware OQ Exist Exist
Hardware PQ Exist Exist
Computer/PLC Configuration
Model/Brand hp
Processor Type Intel Core I5
Ram 16G
Hard Disk Size 1 TB
Screen Size 19
Printer Model hp
Operating system Win 10
Machine/Computer Interface (Check the Correct Type)

Ethernet Connector Ethernet Connector
ENTERPRISE 7
Analytical Equipment System Description

Name (Description) EMPOWER 3
Country of Origin USA
Supplier Waters
Vendor ELMEHY
Model EMPOWER 3
Issue Date 12/2020
GxP / Non-GxP GXP
IQ Status Exist
Equipment Control (Y/N)
(The operator can control the
Y
equipment through this
application)
Key objectives and benefits of the system

Ser. Objective Description
1 Control chromatograph systems ( HPLC – UPLC- GC ) with data integrity
2 Derivative Measurements
ENTERPRISE 7
3. User Requirement Specification

List the user requirement from the system in the following table, Include the following main
requirement in all systems
User Requirement List
ID Function / Process Requirement Process Details Output document Responsible
1 System Security Each user must have unique user name Check the O.Q. tests System
and password Administrator
2 Access Control Each user must have a specified Check the O.Q. tests System
responsibilities Administrator
3 Audit Trail The system is simple and no data history Check the O.Q. tests System
in the device, so the user cannot change Administrator
or delete the old data and the printed
report approved by two independent
persons so no need for audit trail .
4 Auto-logoff The system has to logoff after a specified Auto-logoff System
Idle time challenge Administrator
URS Prepared By URS Reviewed URS Approved By Q.A. Lead

By
Hazem Ahmed Madian Senior Analyst Mohamed AbdElrahman Ahmed El saharty

ENTERPRISE 7
4. Access Control Levels

EMPOWER 3 ENTERPRISE User Program each user can have the required privileges
according to his authorization like {Analyst, Supervisor, Lab_ manager, Administrator}
Security Level Exist/ Not Exist
Analyst Exist / Custom
Supervisor Exist / Custom
Lab_ manager Exist / Custom
Administrator Exist / All options
4.1 Attached documents:
The user access control levels description from the EMPOWER 3 ENTERPRISE
4.1.1 Analyst rights (Attached – 1)
4.1.2 Supervisor rights (Attached – 2)
4.1.3 Lab_ manager rights (Attached – 3)
4.1.4 Administrator rights (Attached – 4)
ENTERPRISE 7
5. System Function Specification
FS. Ref. URS Reference Process Description Functionality Comment

1 1 System Security User Setup Utility for _____
EMPOWER 3 ENTERPRISE
1 2 Access Control User Setup Utility for _____
EMPOWER 3 ENTERPRISE
2 3 Audit Trail System Administration _____
3 4 Auto-logoff System Administrator _____

ENTERPRISE 7
6. Supplier Assessment
Decisions to purchase software, hardware and related services from external suppliers should only
be taken when there is confidence that these will be fit for purpose.
Refereeing to {Computer System validation} and supplier assessment.
The following decision tree should be followed to decide whether or not to audit the supplier.
Where the selected supplier is not audited, this decision should be formally documented and
justified in accordance with this decision tree.
Since this validation report concern to Category 3 System so on-site audit is not required. But
The supplier must fulfill the following requirements.
Supplier Assessment Point Result

Supplier reputation(Good/Bad) Good
Product Reputation(Good/Bad) Good
Previous feedback about the supplier(Good/Bad) Good
Previous feedback about the product (Good/Bad) Good
Design Specification Documentations Exist (Y/N) Yes
Installation Qualification Exist (Y/N) Yes
Operation Qualification Exist (Y/N) Yes
Performance Qualification Exist (Done by supplier) (Y/N) Yes
User Manual Exist (Y/N) Yes
Training Materials Exist (Y/N) Yes
Supplier Assessment Result

Approved
Supplier Approved (Y/N)
Y
ENTERPRISE 7
7. Risk Assessment
7.1 High level System Risk Assessment
The following validation determination from points assess the system criticality if any point answer is yes then
the system has to be validated the number of Yes’s represent the system criticality.
Validation Determination Form
System Category 3
Does the application or system directly control record for use, or monitor product quality? Y
Does the application or system directly control, record for use, or monitor laboratory testing or clinical data? Y
Does the application or system affect regulatory submission/registration? N
Does the application or system perform calculations/algorithms that will support a regulatory N
submission/registration?
Is the application or system an integral part of the equipment, instrumentation, or identification methods used Y
in testing, release, and/or distribution of the product/samples?
Does the application or system define materials (i.e., raw materials, packaging components, formulations, etc.) N
to be used?
Can the application or system be used for product/samples recall, reconciliation, stock tracing, product history,
or product-related customer complaints?
N
Will data from the application or system be used to support Quality Control or product release? Y
Does the application or system deal with coding of materials, formulated products, or package components N
(i.e., labels or label identification)?
Does the application or system handle data that could affect product quality, strength, efficacy, identity, status, Y
or location?
Does the application or system employ any electronic signature capabilities or provide the sole record of the N
signature on a document subject to review by a regulatory agency?
Is the application or system used to automate a manual Quality Control check of data subject to review by a Y
regulatory agency?
Does the application or system create, update, or store data prior to transferring to an existing validated N
system?
Is the application or system the official archive or record of any regulated activity and thus subject to Y
regulatory audit?
Validation (Y/N) Y
Required
Acknowledgmen The Computer System have to be validated { the supplier make prospective
t of validation Validation }
requirements
Name/Title Signature Date
Prepared By Tamer Awad / IT Software Quality Senior
Ahmed Alsayed / IT Manager
Ahmed El saharty / Q.A Lead
Ahmed Mokhtar / IT Lead
Hazem Ahmed Madian / Senior Analyst
Eng. Mohamed Abd Elrahman / CIO Pharco Corporation
Approved By
Dr. Mohamed Eltoukhy / QA Manager
7.2 System Function Risk Assessment
Assess the user requirement and system functions using Failure Modes and Effects Analysis (FMEA) form, the risk assessment will start
with the main system requirements {System Security, System Access Control, and Audit Trail} if they are required in URS.
Refer to {Risk Assessment SOP} on how to determine the risk (severity, Occurrence, and detectability) figures.
Failure Modes and Effects Analysis (FMEA)

Main Validation Requirements (System Administration Requirements)
Risk Assessment Risk Control
Effect Action By
(Risk) DET
RA Ref. Function FS Ref. URS Ref. GxP SEV Cause of failure OCC Control RPN Action (responsibility)
Failure Mode
/Business
Authorized users
Define a user on the Unauthorized user can System has no System
1 1 1 Gxp 10 1 only can access 1 10 Challenge sytem security
system access the system data security issue Administrator
the system
Disable a user
User can access the Can’t Disable login for some
Challenge diabling user System
2 Enable/Disable user 1 1 system when required Gxp 10 user for a period 5 time without 8 400
from the system Administrator
to be hold of time changing any of
his responsibilities
User has rights
on all User Rights SOP
User can access a Exclude some
Enable/Disable user responsibility
unauthorized function Functions from System
4 access to function or 1 1 Gxp 10 functions where 8 8 640 Challenge excluding
in an authorized responsibility per Administrator
role it needs to deny some functions from
responsibility user
access of some responsibility per user
functions
User need to Train the Users to
The user can change User Can’t Change his User can change System
4 1 1 Gxp 10 change his own 10 1 100 change his own
his own password own password his own password Administrator
password password
System
Reset User Password Test Administrator
User Forget his User Forget his Administrator can System
5 by the system 1 Gxp 10 7 10 700 capability to reset user
1 password password reset any user Administrator
Administrator password
password
Main Validation Requirement (System Administration Requirements)
Risk Assessment Risk Control

Effect Action By
(Risk) DET
RA Ref. Function FS Ref. URS Ref. GxP SEV Cause of failure OCC Control RPN Action (responsibility)
Failure Mode
/Business
Challenge the acess
User can access data User access
Make roles for levels, apply system System
6 Access Control 1 2 which is not allowed to Gxp 10 unauthorized 7 5 350
each access level Security SOP for adding Administrator
him information
any user/function
If User can
Operator can change The system change Gxp Data
Gxp Data Challenge xistence of System
7 1 3 GxP data without Gxp 10 have no audit 8 Activate the audit 8 640
Traceability audit trail functionality Administrator
traceability trail cabablity trail function for
these data
User leave his
User leave his disk for disk for a period
Session logout after System has to
a period of time, and of time, and Check System Auto I.T System
8 specified idle time 1 4 xp 10 10 auto logout after 10 1000
another on can access another on can logout Administrator
period idle time
authorized data access
authorized data
Ahmed Mokhtar IT Lead
8. Traceability Matrix
System Administration Traceability Matrix

URS ID FS ID RA ID Test ID Test Description Test Case ID Test Case Name Status Date/Sign
1 1 1 TS.01 Test User Login/Logout (User Security) TS.01.01 Login with Random user name/password
TS.01.02 Define New User with specified responsibilities
TS.01.03 Login using the defined user name with wrong
password
TS.01.04 Login using the defined user name with Right
password
1 1 2 TS.02 Enable/Disable user TS.02.01 Login with Existing User Name and password
TS.02.02 Disable The User Login and Save the data
TS.02.03 Login with the Disabled User name/password
TS.02.04 Enable that user again
TS.02.05 Login with the same User name/password
1 1 3 TS.03 Enable/Disable user access to function or role TS.03.01 Login with Existing User Name and password
T.03.02 Disable responsibility for a User Login and Save
the data
TS.03.03 Login with the User name/password and check
the disabled responsibility
TS.03.04 Enable responsibility for a User Login and Save
the data
TS.03.05 Login with the same User name/password and
check the user responsibilities
1 1 4 TS.04 The user can change his own password TS.04.01 Login with user name/password
TS.04.02 Change the user password

TS.04.03 Login with the new password
1 1 5 TS.05 Reset User Password by the system Administrator TS.05.01 System Administrator Reset user password
TS.05.02 The user login with the assigned password
System Administration Traceability Matrix

URS ID FS ID RA ID Test ID Test Description Test Case ID Test Case Name Status Date/Sign
2 1 6 TS.06 Check Access control levels TS.06.01 Enter to the system as system administrator
TS.06.02 Check system Access levels
TS.06.03 Add new user
TS.06.04 Assign the user to analyst level
TS.06.05 Check the user rights
TS.06.06 Add new user

TS.06.07 Assign the user to Supervisor level
TS.06.08 Check the user rights

3 1 7 TS.07 Gxp Traceability TS.07.01 System Administrator Activate Audit Trail for
Gxp Data
TS.07.02 Change in data
TS.07.03 Check the Audit trail report
4 1 8 TS.08 Session logout after specified idle time period TS.08.01 Login with System Administrator and adjust auto-
logoff period
TS.08.02 Login with a user name and password and let the
system for 10 minutes as idle time
TS.08.03 Try to Access system form

9. Testing and Qualifications
9.1. Installation Qualification
Refer to Installation Qualification Document from the supplier if exist else fill the following table.
Software Specifications
Required Installed
Application name EMPOWER 3 ENTERPRISE Installed
OR WORKGROUP SOFTWARE
FOR SERVERS
Version EMPOWER 3 ENTERPRISE Installed
Supplier Elmehy ok
Done By Supplier Computerize Reviewed By IT Division Approved By IT , QC& QA
9.2. Operation Qualification

IT with the departmental operator/Supplier Perform the Operation Qualification for all
the tests in the test plan according to the traceability matrix, using extreme test data.
Print the Test Evidence (Header) / Form Snapshot / Approval Form
Attachment TEST Description URS FS RA REFERENCE Test Case
REFERENC REFERENC REFERENC
E E E
1 TS.01 Test User 1 1 1 TS.01.01
Login/Logout
(User Security)
TEST Expected Result Actual Result Status

Login with Random user User will not login User doesn’t login PASS
name/password FAIL
E E E
Test User
1 TS.01 Login/Logout 1 1 1 TS.01.02
(User Security)
1- We have to add the user first to AD server.
2- Importing the user from the AD server to the Empower server software.
3- The user will login to the computer(client) ,then to the empower system with the same
(user name and password)

Define New User with PASS
User will be defined Successfully defined new user FAIL
specified responsibilities

REFERENCE REFERENCE REFERENCE
Test User
Login/Logout
1 TS.01 1 1 1 TS.01.03
(User
Security)

Login using the defined user User will not login Invalid user or password PASS
name with wrong password FAIL


E E E
Test User
1 TS.01 Login/Logout 1 1 1 TS.01.04
(User Security)
- The user will login to the computer(client) ,then to the empower system with the same
user name and password)
-

Login using the defined User will login Successfully login PASS
user name with Right FAIL
password


REFERENC REFERENCE REFERENC
E E
Enable/Disable
1 TS.02 1 1 1 TS.02.01
user
Login with Existing User User will login Successfully login PASS
Name and password FAIL


E E
Enable/Disable
1 TS.02 1 1 1 TS.02.02
user
Disable The User Login User will be disabled Successfully disabled PASS
FAIL

Attachment TEST Description URS FS RA Test Case
REFERENCE REFERENCE REFERENCE REFERENCE
1 TS.02 Enable/Disable 1 1 1 TS.02.03
user
Login with the Disabled User will be disabled User disabled PASS
User name/password FAIL


E E E
1 TS.02 Enable/Disable 1 1 1 TS.02. 04
user
Enable that user again User will be enabled User enabled PASS
FAIL

Attachment TEST Description URS FS RA Test Case
REFERENCE REFERENCE REFERENCE REFERENCE
1 TS.02 Enable/Disable 1 1 1 TS.02. 05
user
Login with the same User will login Successfully login PASS
User name/password FAIL


user access to
function or role
Login with Existing User User will login Successfully login PASS
Name and password FAIL


E E
user access to
function or
role
Disable responsibility for a Responsibility will be Responsibility Disabled PASS
User Login ,by custom his Disabled FAIL
level


E E
user access to
function or
role

Login with the User Responsibility will be Responsibility is found Disabled PASS
name/password and check find Disabled FAIL
the disabled responsibility

E E
user access to
function or
role

Enable responsibility for a Responsibility will be Successfully enabled PASS
User Login and Save the data enabled FAIL


E E
user access to
function or
role

Login with the same User User responsibilities will User responsibilities existed PASS
name/password and check be existed FAIL
the user responsibilities


E E E
1 TS.04 The user can 1 1 1 TS.04.01
change his
own password

Login with user User will login Successfully login PASS
name/password FAIL


E E E
The user can
1 TS.04 change his 1 1 1 TS.04.02
own password
- The user can change his password through logging to the computer (client) , then the
password will be automatically changed in the empower system .

Change the user Password will be PASS
Password successfully changed
password changed FAIL


E E E
The user can
1 TS.04 change his 1 1 1 TS.04.03
own password

Login with the new User will login Successfully login PASS
password FAIL


E E E
1 TS.05 Reset User 1 1 1 TS.05.01
Password by
the system
Administrator
- The administrator can change the user password through the AD server, then the
password will be automatically changed in the empower system.

System Administrator Password will be Password successfully changed PASS
Reset user password changed FAIL


E E E
Reset User
Password by
1 TS.05 1 1 1 TS.05.02
the system
Administrator

The user login with the PASS
User will login Successfully login
assigned password FAIL


E E E
Check Access
1 TS.06 1 1 1 TS.06.01
control levels
- The system administrator is the same administrator for the (AD & Empower) servers
Enter to the system as User will login Successfully login PASS
system administrator FAIL


E E E
1 TS.06 Check Access 1 1 1 TS.06.02
control levels
Check system Access Access levels will be Access levels Are Checked PASS
levels Checked FAIL

REFERENCE REFERENCE REFERENC
E
Check Access
1 TS.06 1 1 1 TS.06.03
control levels
PASS
Add new user User will be added Successfully adding new user
FAIL


E E E
Check Access
1 TS.06 1 1 1 TS.06.04
control levels
Assign the user to the PASS
User will be assigned Successfully assigned
analyst level FAIL


E E E
1 TS.06 Check Access 1 1 1 TS.06.05
control levels
Check the user rights User rights Checked User rights Checked PASS
FAIL

Check Access
1 TS.06 1 1 1 TS.06.06
control levels
PASS
Add new user User will be adding Successfully adding new user FAIL


E E E
Check Access
1 TS.06 1 1 1 TS.06.07
control levels
Assign the user to PASS
User will be assigned Successfully assigned
supervisor level FAIL

E E E
Check Access
1 TS.06 1 1 1 TS.06.08
control levels

PASS
Check the user rights User rights Checked User rights Checked
FAIL

E E E
1 TS.07 Gxp Traceability 1 1 1 TS.07.01

System Administrator Audit Trail will be Audit Trail Aoutomaticlly Activated PASS
Activated FAIL
Activate Audit Trail for
Gxp Data

E E E
Gxp
1 TS.07 1 1 1 TS.07.02
Traceability

PASS
Change in data Data will be changed Data will Is changed
FAIL

Position/Title Signature Date Done By Position/Title Signature Date
Gxp
1 TS.07 1 1 TS.07.03
Traceability 1

Check the Audit trail Audit trail report will be Audit trail report is checked PASS
report checked FAIL


E E E
Session logout
after specified
1 TS.08 1 1 1 TS.08.01
idle time
period

Login with System
The auto-logoff period PASS
Administrator and adjust auto-logoff period is adjusted
will be adjusted FAIL
auto-logoff period

E E
1 TS.08 Session logout 1 1 1 TS.08.02
after specified
idle time
period

Login with a user name
and password and let Password will be PASS
Password is requested
the system for requested FAIL
10minutes as idle time

E E E
Session logout
after specified
1 TS.08 1 1 1 TS.08.03
idle time
period
Try to Access system User will login Successfully login PASS
with the user FAIL

9.3 Performance Qualification
IT with the departmental operator/Supplier Perform the Operation Qualification for all
the tests in the test plan according to the traceability matrix, with real data in the real
world.
10. Maintaining the Validated Status

10.1 User Procedure
User Procedure can be done by supplier or internally in the company
If applicable attach it to the validation report
User (Procedure) Manual Exist Y
Training Record on procedure Exist Y
Checked By (IT senior ) Y
Approved By (CIO Pharco Corporation) Y
10.2 Security Management
Security Policy Challenged in the department (Y/N) Y

User Security Challenge (according to risk assessment) refer to challenge attachment Y
(Y/N)
10.3 Maintenance and Calibration and supplier services
Responsibility Department/ Contract Type (SLA) Review Period

Supplier name (Periodically/ Call)
Internal IT Team Call N/A
External Call N/A
Elmehy
10.4 Backup and Restoration
Period Backup Media Safe Place

Daily NAS Storage System
Administration
Dept.,
Backup Challenge
Done by Ahmed Mokhtar \ Signature:
Reviewed by Tamer Awad \ Signature:
Restore Challenge
Done by Ahmed Mokhtar \ Signature:
Reviewed by Tamer Awad \ Signature:
10.5 Disaster recovery and continuity plan
10.5.1 NAS Storage .
10.5.2 SLA with Supplier ( Call ).
10.6 Periodic Review

Revalidation review every 3 years and according to SOP IT/O/009
10.7 Training
Training Record for the application Exist(Y/N) Y
Training by (Supplier/Internal) Internal
10.8 Change Control

Change Control SOP Number A/O/049
Change Control SOP in Place (Y/N) Y
Change Control SOP in use (Y/N) Y
10.9 Incident Management
Incident Management SOP Number IT/O/022

Incident Management in Place (Y/N) Y
Incident Management in use (Y/N) Y
11.0 Analytical Equipment System Quality Management

Validation Final Report
Department /Sector: IT.
Section : SA.
System Description: HPLC USING EMPOWER 3 ENTERPRISE
Machine/Device Application Computer

Name HPLC I Name Empower Brand hp
Model 1200 Version 03 Processor Core I5
Supplier waters Supplier Elmehy Ram 16G
Vendor Elmehy Issue Date 2020 HD 1 TB
Mfg. Date ----- ----- ----- Monitor 19
Validation Y
Retrospective Prospective Type
System ToY Quality to Business Criticality
GAMP Category 3
11.1 Validation Activities Result
Required Activities Retrospective Validation SOP Reference Number
User Requiring Exist Y Not Exist IT/O/010
Function/Design Specification Exist Y Not Exist IT/O/009
Exist Y Not Exist

System Security IT/O/026
Challenged: Yes Y No
Exist Y Not Exist
Access Control IT/O/027
Challenged: Yes Y No
Supplier Assessment Exist Y Not Exist IT/O/027
Risk assessment Exist Y Not Exist IT/O/031
Traceability Matrix Exist Y Not Exist IT/O/027
IQ. Exist Y Not Exist

IT/O/009,
OQ. Exist Y Not Exist The Machine Manual
P.Q Exist Y Not Exist
User procedures (S.O.P) Exist Y Not Exist C/INP/O/085
Maintenance and calibration

plan
Exist Y Not Exist IT/O/009
System Backup and Restore

S.O.P
Disaster Recovery and
continuity plan
Audit Trail Exist Y Not Exist IT/O/009

Not Needed
y
Periodic Review Period Daily Backup IT/O/022
Supplier Service Exist Y Not Exist P/OP/007
Change Control Exist Y Not Exist IT/O/022 & A/O/049
Incident Management Exist Y Not Exist IT/O/022
Training Records Exist Y Not Exist T/O/011
12.0 Conclusion:
The System is successfully validated and released to use/Continue Use “starting from 03/2021”.
Validation Report Approval
Central lab Lead CIO Pharco Corporation QA Manager

Eng. Amr Salah Eng.Mohamed Abd Elrahman Dr. Mohamed Eltoukhy

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EMPOWER 3 ENTERPRISE SOP: TMP Code Version Review date: Copy Page

OR WORKGROUP SOFTWARE FOR IT/O/027 IT/V/INS/001 No.: 01 3/2024 No.: 1/52

EMPOWER 3 ENTERPRISE OR WORKGROUP SOFTWARE FOR SERVERS

1. Validation Report Introduction

1.3. Assumptions and Limitations

1.6. How to use this document?

1.6.4 Supplier Assessment:

Done By Position/Title Signature Date

1.7. Introduction to the objective System

Machine/Device (Hardware Specification)

Machine/Computer Interface (Check the Correct Type)

Analytical Equipment System Description

Key objectives and benefits of the system

3. User Requirement Specification

URS Prepared By URS Reviewed URS Approved By Q.A. Lead

Hazem Ahmed Madian Senior Analyst Mohamed AbdElrahman Ahmed El saharty

4. Access Control Levels

4.1 Attached documents:

5. System Function Specification

FS. Ref. URS Reference Process Description Functionality Comment

3 4 Auto-logoff System Administrator _____

Supplier Assessment Point Result

Supplier Assessment Result

Failure Modes and Effects Analysis (FMEA)

Main Validation Requirement (System Administration Requirements)

Risk Assessment Risk Control

System Administration Traceability Matrix

TS.04.02 Change the user password

System Administration Traceability Matrix

TS.06.06 Add new user

TS.06.08 Check the user rights

TS.07.02 Change in data

TS.07.03 Check the Audit trail report

TS.08.03 Try to Access system form

9.2. Operation Qualification

TEST Expected Result Actual Result Status

TEST Expected Result Actual Result Status

Attachment TEST Description URS FS RA REFERENCE Test Case

TEST Expected Result Actual Result Status

Done By Position/Title Signature Date

Attachment TEST Description URS FS RA REFERENCE Test Case

TEST Expected Result Actual Result Status

Done By Position/Title Signature Date

Attachment TEST Description URS FS RA REFERENCE Test Case

Done By Position/Title Signature Date

Attachment TEST Description URS FS RA REFERENCE Test Case

Done By Position/Title Signature Date

Done By Position/Title Signature Date

Attachment TEST Description URS FS RA REFERENCE Test Case

Done By Position/Title Signature Date

Done By Position/Title Signature Date

Attachment TEST Description URS FS RA REFERENCE Test Case

Done By Position/Title Signature Date

Attachment TEST Description URS FS RA REFERENCE Test Case

Done By Position/Title Signature Date

Attachment TEST Description URS FS RA REFERENCE Test Case

TEST Expected Result Actual Result Status