Healthcare Chemicals Limited.

STANDARD OPERATING PROCEDURE API Industrial Park, BSCIC,

Gazaria, Munshiganj, Bangladesh
Department: Qualification & Validation Page 1 of 11
SOP No.: SOP NAME: COMPUTERIZED SYSTEM Effective Date:
GEQ&V- VALIDATION (CSV)
003.00 Review Date:

Function Name Designation Sign Date

Prepared By
Qualification &
S. M. Abu Baser Rocky Sr. Executive, Q&V
Validation
Reviewed By
Qualification &
Md. Shanawas Rashid In-Charge, Q&V
Validation

Quality Control Mohammad Rasel Mia Asst. Manager, QC

Deputy Manager,
Production Md. Saidur Rahman
Pellet Production
Deputy Manager,
Engineering Md. Hasibur Rahman
Engineering
Deputy Manager,
Engineering S. M. Sajjad Hossain
Engineering
Approved By
Quality Chowdhury Maroof Assistant Manager,
Assurance Ahmed Quality Assurance

Authorized By
Technical GM, Technical
Md. Barkat Ali
Operations Operations

Distribution List: 1. Quality Assurance

2. Quality Control
3. Engineering
4. Research & Development
5. Production
6. Warehouse
7. Qualification & Validation
8. Microbiology
9. Training
1.0 PURPOSE

Head of QA/Designee (Sign/Date) :

FORM No.: FGEQA/001.00 Ref. SOP.: GEQA-001

 Healthcare Chemicals Limited.
STANDARD OPERATING PROCEDURE API Industrial Park, BSCIC,
Gazaria, Munshiganj, Bangladesh
Department: Qualification & Validation Page 2 of 11
SOP No.: SOP NAME: COMPUTERIZED SYSTEM Effective Date:
GEQ&V- VALIDATION (CSV)
003.00 Review Date:

The purpose of this procedure is to carry out Computerized System Validation (CSV)
activities. It defines the procedure and the essential requirements to maintain Computerized
System Validation.

2.0 SCOPE
The scope of this procedure applies to validation activities regarding at GxP critical
Computerized System (mentioned below) at
 PLC based Automated Equipment
 SCADA based Automated Equipment
 Laboratory based Equipment / System
of Healthcare Chemicals Limited, API Industrial Park, BSCIC, Gazaria, Munshiganj,
Bangladesh. Computerized Systems that are not critical to product quality (though important for
the efficient and economic operation of the facility) will not be covered under this scope.

3.0 DEFINITION & ABBREVIATION

3.1 Abbreviation:
SOP: Standard Operating Procedure
CSV: Computerized System Validation
URS: User Requirement Specification
FRS: Functional Requirement Specification
FS: Functional Specification
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification
DQ: Design Qualification
FRA: Functional Risk Assessment
VMP: Validation Master Plan
IT: Information Technology
DS: Design Specification

Head of QA/Designee (Sign/Date) :

FORM No.: FGEQA/001.00 Ref. SOP.: GEQA-001

 Healthcare Chemicals Limited.
STANDARD OPERATING PROCEDURE API Industrial Park, BSCIC,
Gazaria, Munshiganj, Bangladesh
Department: Qualification & Validation Page 3 of 11
SOP No.: SOP NAME: COMPUTERIZED SYSTEM Effective Date:
GEQ&V- VALIDATION (CSV)
003.00 Review Date:

3.2 Definition:
URS (User Requirement Specification):
An URS is an approved statement that outlines the basic requirements for any system and
therefore URS contains a set of criteria or conditions that have to be met. The URS will be a
point of reference throughout the validation life cycle.
Design Qualification (DQ):
Documented verification that the proposed design of the facilities, equipment or systems is
documented as being suitable for the intended purpose.
Installation Qualification (IQ):
IQ is defined as "Establishing confidence that process equipment and ancillary systems are
capable of consistently operating within established limits and tolerances". It should ensure that
the equipment and ancillary systems are installed in accordance with approved design,
specifications and regulatory requirements.
Operational Qualification (OQ):
The documented verification that the facilities, systems and equipment, as installed or modified,
perform as intended throughout the anticipated operating ranges.
Performance Qualification (PQ):
The documented verification that the facilities, systems and equipment, as connected together,
can perform effectively and be replicated, based on the approved process method and product
specification.
Validation:
An action proving, in accordance with the principles of Good Manufacturing Practice, that any
procedure, process, equipment, material, activity or system actually leads to the expected
results. A documented program that provides a high degree of assurance that a specific process,
method or system will consistently produce a result meeting.
DS (Design Specification):
The document includes design details of the system. This documents links installation
qualification. DS is normally written by the Vendor and shall be reviewed and approved by
user.

Head of QA/Designee (Sign/Date) :

FORM No.: FGEQA/001.00 Ref. SOP.: GEQA-001

 Healthcare Chemicals Limited.
STANDARD OPERATING PROCEDURE API Industrial Park, BSCIC,
Gazaria, Munshiganj, Bangladesh
Department: Qualification & Validation Page 4 of 11
SOP No.: SOP NAME: COMPUTERIZED SYSTEM Effective Date:
GEQ&V- VALIDATION (CSV)
003.00 Review Date:

Revalidation/Requalification:
Revalidation means documentation and execution of the complete set of validation activities
and deliverables that were initially performed.
Template:
A format to be used in the preparation of documents for general activities such as equipment
qualification, process validation etc. Templates contain outlines of the minimum requirements
that should be included in a protocol.
Validation Protocol:
A written plan stating how validation will be conducted and defining acceptance criteria. For
example, the protocol for a manufacturing process identifying processing equipment, critical
process parameters/operating ranges, product characteristics, sampling, test data to be collected,
the number of validation runs and acceptable test results.
Periodic Review:
Periodic reviews are performed to ensure that the Computerized system remains within both
company and regulatory compliance, and is fit for its intended use. The review evaluates the
compliance status of the entire system and plans any required corrective action activities.
Configuration Document (CD):
The Configuration Document (CD) should contain the technical documentation of the additional
(to the standard) configuration which is needed to meet the requirements of an implemented
company.
Revalidation:
Revalidation means documentation and execution of the complete set of validation activities
and deliverables that were initially performed.

4.0 RESPONSIBILITY
Activities Person / Department
Protocol & Report preparation Qualification & Validation
Review of the Protocol & Report Engineering, Qualification & Validation, IT
Approval of Protocol & Report Quality Assurance

Head of QA/Designee (Sign/Date) :

FORM No.: FGEQA/001.00 Ref. SOP.: GEQA-001

 Healthcare Chemicals Limited.
STANDARD OPERATING PROCEDURE API Industrial Park, BSCIC,
Gazaria, Munshiganj, Bangladesh
Department: Qualification & Validation Page 5 of 11
SOP No.: SOP NAME: COMPUTERIZED SYSTEM Effective Date:
GEQ&V- VALIDATION (CSV)
003.00 Review Date:

Member of Validation Team (Engineering,

Testing and Data processing Qualification & Validation, IT and Quality
Assurance)
Authorization of Protocol & Report Technical Operations

5.0 ACCOUNTABILITY
Head of QA / Q&V / User Department

6.0 PRECAUTION
6.1 Only trained personnel are allowed to carry out the Computerized System Validation.
6.2 To keep computerized system validated throughout the lifecycle of that computerized
system.

7.0 PROCEDURE
7.1 Concept Phase:
7.1.1 Perform GxP Assessment for the Computerized system considering GxP Impact
Assessment Categorization of System Software and Hardware, Electronic Records and
Electronic Signature (ERES) Assessment.
7.1.2 Categorize the System Software and Hardware (as per Appendix-I) to establish the
validation approach with deliverables.
7.2 Project Phase
7.2.1 Determine the range of activities to validate a Computerized system by GAMP 5
software and hardware categorization, GxP impact, applicable electronic records and
electronic signatures requirements, and its risk-based lifecycle approach.
7.2.2 Perform the supplier assessment (where required) based on risk assessment through one
of the following:
a) Basic checklist
b) A postal questionnaire
c) An onsite audit

Head of QA/Designee (Sign/Date) :

FORM No.: FGEQA/001.00 Ref. SOP.: GEQA-001

 Healthcare Chemicals Limited.
STANDARD OPERATING PROCEDURE API Industrial Park, BSCIC,
Gazaria, Munshiganj, Bangladesh
Department: Qualification & Validation Page 6 of 11
SOP No.: SOP NAME: COMPUTERIZED SYSTEM Effective Date:
GEQ&V- VALIDATION (CSV)
003.00 Review Date:

7.2.3 Perform risk assessment (may be at different stage of Validation process) by

multidisciplinary team
7.2.4 Prepare an inventory list of Computerized systems including new Computerized system
for CSV for existing Computerized system.
7.2.5 Prepare VMP for Computerized system. Separate VMP can be prepared if necessary.
VMP should include the following (Not Limited):
a) Purpose
b) Scope
c) Responsibilities
d) References
e) Project System Overview / Background and System Description
f) Validation Approach
g) SOP
h) Training
i) Report of Discrepancy
j) Change Control Procedure
k) Deliverables
l) Acceptance Criteria
m) Operational Phase
n) Retirement Phase
o) Abbreviation
p) Attachment
7.2.6 The Validation Approach will be as per following validation Variables (Not Limited):
a) GxP Assessment
b) GAP Analysis
c) Validation Plan (VP)
d) System Requirement Specification (SRS)
e) Functional Design Specification (FDS)
f) Functional Risk Assessment (FRA)

Head of QA/Designee (Sign/Date) :

FORM No.: FGEQA/001.00 Ref. SOP.: GEQA-001

 Healthcare Chemicals Limited.
STANDARD OPERATING PROCEDURE API Industrial Park, BSCIC,
Gazaria, Munshiganj, Bangladesh
Department: Qualification & Validation Page 7 of 11
SOP No.: SOP NAME: COMPUTERIZED SYSTEM Effective Date:
GEQ&V- VALIDATION (CSV)
003.00 Review Date:

g) Installation Qualification (IQ)

h) Operational Qualification (OQ)
i) Performance Qualification (PQ)
j) Validation Summary Report (VSR)

7.2.7 Prepare URS (if not available or sufficient data enough for CSV) which may include
Input/output Alarms/Interlocks / Messages, security & access control, access/privilege
level, data storage/ data archive/Data backup, HMI Parameters/Screens,
power/communication failure, operating environment Hardware configuration, Audit
Trail, Data security (no access to database directly for any operation)
7.2.8 Provide (by supplier) the following documents for complex Computerized systems:
a) FS / FRS
b) DS/ DQ
7.2.9 Prepare CD (Configuration document) for configured software where necessary
7.2.10 Perform code review after custom software where necessary
7.2.11 Create & Perform data migration plan where data has to migrate from legacy system to
new system
7.2.12 Prepare IQ protocol & Report for that Computerized system which will include
verification of the following (Not Limited):
a) Verification of System Identification
b) Verification of System Documentation
c) Verification of System Network Configuration / Hardware Components
d) Verification of System Software Configuration
e) Verification of Software backup certification / letter
f) Verification of Power Utility
g) Verification of Environmental Conditions
7.2.13 Prepare OQ protocol & Report for that Computerized system which will include
verification of the following (Not Limited):
a) Verification of System Start-up and Shutdown

Head of QA/Designee (Sign/Date) :

FORM No.: FGEQA/001.00 Ref. SOP.: GEQA-001

 Healthcare Chemicals Limited.
STANDARD OPERATING PROCEDURE API Industrial Park, BSCIC,
Gazaria, Munshiganj, Bangladesh
Department: Qualification & Validation Page 8 of 11
SOP No.: SOP NAME: COMPUTERIZED SYSTEM Effective Date:
GEQ&V- VALIDATION (CSV)
003.00 Review Date:

b) Verification of Graphic Pages / Process Graphics

c) Verification of Control System Input/ Output
d) Verification of Access Control / User Access (Access Privileges) and Security
Policy
e) Verification of Audit Trail
f) Verification of User Profile
g) Verification of Password Challenge Test
h) Verification of User Management and Password Policies Challenge Test
i) Verification of Operational Sequences
j) Verification of Critical Parameters
k) Verification of Date/ Time Change Challenge Test
l) Verification of Data Backup and Restoration
m) Verification of Control System Power Failure Condition
n) Verification of Control System Communication Failure Condition
o) Verification of Set Parameter Range
p) Verification of Alarms/ Interlocks
q) Verification of System Generated Report / Printing & Reporting
r) Verification of ERES/ 21 CFR Part 11
7.2 14 Prepare PQ / Periodic Review / Re-validation protocol & Report for that Computerized
system which will include verification of the following (Not Limited):
a) Verification of System Start-up and Shutdown
b) Verification of Graphic Pages / Process Graphics
c) Verification of Control System Input/ Output
d) Verification of Access Control / User Access (Access Privileges) and Security
Policy
e) Verification of Audit Trail
f) Verification of User Profile
g) Verification of Password Challenge Test
h) Verification of User Management and Password Policies Challenge Test

Head of QA/Designee (Sign/Date) :

FORM No.: FGEQA/001.00 Ref. SOP.: GEQA-001

 Healthcare Chemicals Limited.
STANDARD OPERATING PROCEDURE API Industrial Park, BSCIC,
Gazaria, Munshiganj, Bangladesh
Department: Qualification & Validation Page 9 of 11
SOP No.: SOP NAME: COMPUTERIZED SYSTEM Effective Date:
GEQ&V- VALIDATION (CSV)
003.00 Review Date:

i) Verification of Operational Sequences

j) Verification of Critical Parameters
k) Verification of Date/ Time Change Challenge Test
l) Verification of Data Backup and Restoration
m) Verification of Control System Power Failure Condition
n) Verification of Control System Communication Failure Condition
o) Verification of Set Parameter Range
p) Verification of Alarms/ Interlocks
q) Verification of System Generated Report / Printing & Reporting
r) Verification of ERES/ 21 CFR Part 11
7.2.15 Perform validation through V-Model for Computerized System Validation (CSV) (as
per appendix-II).
7.2.16 Execute IQ, OQ or PQ / Periodic Review / Re-validation as per concerned protocol.
7.2.17 Write down any discrepancies or variations observed during the execution of the
qualification and deviation is handled as per SOP: GEQA-009.
7.2.18 Prepare Requirement Traceability Matrix (RTM) where necessary.
7.2.19 Prepare summary report as per validation summary report template of CSV.
7.2.20. Train up end user with the help of training manual.
7.2.21 Service Level Agreement (SLA) should be in place where necessary SLA documents
a
mutual formal agreement for the service provided between all parties
7.3 Operation Phase:
7.3.1 Raise formal change control (as per SOP: GEQA-010) for any change to
Computerized
systems
7.3.2 Evaluate change control through risk assessment for the extent of revalidation for that
Computerized system
7.3.3 Evaluate all Computerized systems annually as per Appendix I or II.

Head of QA/Designee (Sign/Date) :

FORM No.: FGEQA/001.00 Ref. SOP.: GEQA-001

 Healthcare Chemicals Limited.
STANDARD OPERATING PROCEDURE API Industrial Park, BSCIC,
Gazaria, Munshiganj, Bangladesh
Department: Qualification & Validation Page 10 of 11
SOP No.: SOP NAME: COMPUTERIZED SYSTEM Effective Date:
GEQ&V- VALIDATION (CSV)
003.00 Review Date:

7.3.4 Take decision for revalidation requirement and the extent of revalidation for
Computerized system based on evaluation (annual evaluation or change control
evaluation).
7.3.5 Prepare and execute simple verification protocol (proving that the software is configured
as before change) if same version of software is reinstalled.
7.3.6 Determine the competency and reliability of external validation agency.
7.3.7 Ensure vendor qualification where external validation agency is involved for CSV.
7.3.8 Ensure formal agreement between company and external validation agency that includes
clear statements of responsibilities.
7.3.9 Ensure backup and restoration of electronic data.
7.3.10 Ensure Disaster Management and recovery of Computerized system.
7.3.11 Data should be archived as required.
7.3.12 Periodic Review / Re-validation:
Computerized systems should be periodically reviewed to determine whether the system
remains in a validated state or whether there is a need for revalidation. Evaluate
Computerized system annually for Laboratory based Equipment / System (as per
Appendix-III) and PLC / SCADA based Equipment / System (Appendix-IV) for review /
Revalidation purpose. The frequency of review (Periodic Review) / revalidation depends
on system criticality, risk business impact and complexity.
Revalidation will be performed when significant changes are made. However final
decision should be based on risk assessment:
a) Major changes which also impact the structure
b) Major system faults
c) New hardware and/or software added to existing system
d) New functionality added to the existing Computerized system application
7.3.13 Raise Change Control (as per SOP: GEQA-010) for any changes/modifications to be
implemented in Computerized system.
7.4 Retirement Phase:

Head of QA/Designee (Sign/Date) :

FORM No.: FGEQA/001.00 Ref. SOP.: GEQA-001

 Healthcare Chemicals Limited.
STANDARD OPERATING PROCEDURE API Industrial Park, BSCIC,
Gazaria, Munshiganj, Bangladesh
Department: Qualification & Validation Page 11 of 11
SOP No.: SOP NAME: COMPUTERIZED SYSTEM Effective Date:
GEQ&V- VALIDATION (CSV)
003.00 Review Date:

Generate a retirement protocol, in case of a validated Computerized system is to be

retired.
Take at least the following considerations into account:
a) Archiving of data and records retention requirements
b) Hardware disposal
8.0 REFERENCES
8.1 GAMP-5: A Risk-Based approach to Compliant GxP Computerized Systems
8.2 EU GMP Annex 11: Computerized System
8.3 US FDA 21 CFR Part11 Electronic Records and Electronic Signatures

9.0 REVISION HISTORY:

Reason for revision of SOP shall be given as indicated below.
Sl. No. Revision Effective Date Details of Revision Remarks
Status

01 00 New First Issue

10.0 LIST OF APPENDICES

Appendix-I: Categorization of Software & Hardware System
Appendix-II: V-Model for Computerized System Validation (CSV)
Appendix-III: Template of Evaluation Sheet for Laboratory based Equipment / System
Appendix-IV: Template of Evaluation Sheet for PLC / SCADA based Equipment / System

Head of QA/Designee (Sign/Date) :

FORM No.: FGEQA/001.00 Ref. SOP.: GEQA-001