Validation Plan OF Rapid Mixer Granulator

VALIDATION PLAN
M/s. Abbott Healthcare Private Limited, Baddi

Equipment Name: Rapid Mixer Granulator
Document No.: ICS-2102-310-V-02-VP-R0 Equipment ID: TRMG-10
VALIDATION PLAN
OF
RAPID MIXER GRANULATOR
Equipment Name Rapid Mixer Granulator
Equipment ID: TRMG-10

Manufacture Name Glatt®
Location Granulation - 1
Supersedes No.: 00
Effective Date:
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VALIDATION PLAN

TABLE OF CONTENTS
1. Preparation and Approvals................................................................................................................3
2. Revision History..................................................................................................................................4
3. Introduction.........................................................................................................................................5
4. Objective..............................................................................................................................................5
5. Scope.....................................................................................................................................................5
6. System Details......................................................................................................................................6
6.1 System Description..............................................................................................................................6
7. Role and Responsibility......................................................................................................................7
8. References............................................................................................................................................8
9. Documentation Procedure..................................................................................................................9
10. Qualification Completion and Approval...........................................................................................9
11. Documentation Management.............................................................................................................9
12. Validation Approach...........................................................................................................................9
13. Life Cycle Model...............................................................................................................................11
14. Categorization of the Control System.............................................................................................12
15. Validation Deliverables.....................................................................................................................12
16. System Maintenance / Operation and Support Phase...................................................................16
17. Revalidation.......................................................................................................................................19
18. Retirement Phase..............................................................................................................................19
19. Abbreviation......................................................................................................................................20
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VALIDATION PLAN

1. Preparation and Approvals

The signature listed below indicates the preparation and approval of this Document. Approval is joint
responsibility of listed functional areas.
M/S. Instrumentation and control solutions.
Prepared By Name Designation Signature Date
Engineering
Services
Validation
Department
Reviewed By Name Designation Signature Date
User
Department
Engineering
Department
IT Department
Quality
assurance
Department
Approved By Name Designation Signature Date
Quality
Assurance
Department
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VALIDATION PLAN

2. Revision History
Version / Revision
Date Revised Reason for Revision
Number
00 NA Initial Qualification.
Page 4 of 22
VALIDATION PLAN

3. Introduction
M/s. Abbott Healthcare Private Limited is a quality conscious company, engaged in manufacturing of
various pharmaceutical products. M/s. Abbott Healthcare Private Limited follows current Good
Manufacturing Practices and is desirous of implementing international quality norms for validating
their PLC and SCADA based system Rapid Mixer Granulator (TRMG-10).
4. Objective
The objective of validation plan is to provide an organizational approach towards the validation
activities for the PLC and SCADA based system Rapid Mixer Granulator (TRMG-10). This document
will define the requirement and standards that must be followed for all the validation activities as apply
to the PLC and SCADA based system Rapid Mixer Granulator (TRMG-10).
Purpose of this Validation Plan is:
 To define the methodology for validation for the SCADA system activities.
 To identify the roles and responsibilities of persons involved in validation activities.
 To describe brief descriptions of the validation strategies.
 To ensure that SCADA System is fit for intended use and compliant with applicable regulations.
 To outline protocols and test procedures and to define reporting requirements to document the
validation exercise.
5. Scope
This document is applicable to PLC and SCADA based system Rapid Mixer Granulator (TRMG-10)
installed at M/s. Abbott Healthcare Private Limited. This document shall define the test procedures,
documentation, references and acceptance criteria in accordance with the guidelines laid down by the
manufacturer of the system.
6. REASON FOR QUALIFICATION
Please click the appropriate option:
New Installation [√]
Existing Installation [X]
Revalidation [X]
Location change [X]
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VALIDATION PLAN

7. System Details
7.1 System Description
For Rapid Mixer Granulator
A Rapid mixer granulator plays vital role to mix the ingredients and make granules before
compression. For wet granulation, choppers and impellers are mainly responsible in rapid granulator.
This RMG machine is also known in Industries with various key terms as High shear granulation
machine, Dry Powder granulator, Wet Granulator, Pharma Saizoner, High shear mixer granulator,
high-shear granulator, High Shear Mixer Granulators, Granulator, Wet Mixing, Rapid Mixer
Granulator Machine, Granulation Machine, and Rapid Mixer Granulator. Our skilled professionals
have designed the impeller in such a way that full length blades push the material and half-length blade
lift the material. This impeller helps you to break the wet mass into small pieces and granules. Chopper
has very sharp small blades which are specially designed to cut the wet lumps of material into very
small parts which are then mixed by impellers. Discharge port is used to unload the container filled
with granules. It is located at the bottom of the dome. A hard M.S. channel has been used to keep the
drive assembly at the bottom. Stainless steel staircase and railings are provided for the platform with a
bowl mounted on the top. Half of the platform has been covered by S.S. and dimpled Plates.
Programmable Logic Controller (PLC)

PLCs are used to control a process ranging small number of input/outputs to several thousand I/O. In
the latter case, a number of PLCs are usually linked in a SCADA.
The instruments are connected to the system equipment and piping. The collected data is utilized by the
PLC for equipment control.
The user interface shall be provided in the form of SCADA. User can perform various start/stop
operations and monitor the machine status from SCADA.
PLC System consists of a process or unit, an input/output (I/O) system, a memory unit, a programming
language and a power supply. The processor consists of one or more standard or custom
microprocessor and other integrated circuits that perform the computing and control functions of
controlled system.
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VALIDATION PLAN

Supervisory Control and Data Acquisition (SCADA)

The SCADA system can be added to a single PLC or a number of PLCs enable the presentation of the
system information in a more usable format. SCADA manufactures have developed a number of
drivers to enable communication with PLCs.
7.2 System Architecture
Field Instruments
Sensors, Transmitters
etc.
ABBOTT SERVER
PLC
Siemens
(Simatic S7-1500, CPU
1515 -2PN)
SCADA
Siemens
(6AV6 646-1BA18-
0AA0)
PRINTER
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VALIDATION PLAN

8. Role and Responsibility

The validation team comprising of representative from each of the following departments should be
responsible for overall compliance with this document.
Department Responsibilities
 To prepare and submit Validation Plan document for review and
Validation Agency (ICS)
approval.
User Department (M/s.  To review Validation Plan document.

AHPL.)
Engineering (M/s. AHPL)  To review Validation Plan document.
IT (M/s. AHPL)  To review Validation Plan document.
QA (M/s. AHPL)  To review and approve Validation Plan document.
Page 8 of 22
VALIDATION PLAN

9. References
The publication listed below form part of this reference documents. Each publication shall have latest
revision in effect on the date of this document is approved for execution.
Documents/Guidelines Description
Good Automated Manufacturing Practices, Version 5, Guideline
GAMP 5 Document for Automated Systems from International Society of
Pharmaceutical Engineering
21 Code of Federal Current Good Manufacturing Practice in Manufacturing, Processing,
Regulations (CFR), Part 210 Packing, or Holding off Drugs; General
21 Code of Federal
Current Good Manufacturing Practice for finished Pharmaceuticals
Regulations (CFR), Part 211
21 Code of Federal Regulations (CFR), Part 11
21 Code of Federal
Electronic Records, Electronic Signatures, Final Rule Electronic
Regulations (CFR), Part 11
Submissions; Establishment of Public Docket, Notice
International Council of Harmonization (ICH) quality risk
ICH Q9
assessment Q9
FS Glatt 18789_ FS_HSG, Version: 1.00
Operational Qualification
18789_OQ_HSG,Version 1.00
Protocol (Glatt)
Computer system validation
BDI-QA-GN-043 Version No.- 7.0
SOP
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VALIDATION PLAN

10. Documentation Procedure

 Documentation Qualification activities will be performed as defined in the approved document.
 All documentation will be completed during the execution of the qualification.
 Recording of information will be made in permanent blue ink.
 Fill out complete information in the verification table provided.
 Do not keep any space blank. Mark blank space with a single line throughout the appropriate
space with mentioning NA (Not Applicable) and put initial and date.
 Correct the mistakes by drawing a single line through the incorrect data, recording the correct
information and then put initials and date.
 Rectification form/discrepancy is applicable to rectify the error.
 Prior to start of qualification activity, availability of reference document, required information,
access to the subjected system and data of relative system shall be verified.
11. Qualification Completion and Approval
 Verify that all tests required by qualification are completed and attached.
 Verify that all amendments and discrepancies are documented, approved and attached.
 Verify that all annexures and supporting documents are documented, approved and attached
 If all items in the qualification for the SCADA systems have been reviewed and found to be
acceptable, sign the corresponding block in the qualification completion and approval form.
12. Documentation Management
All quality and project relevant documents delivered by ICS are handled through ICS’s document
management system. Each document has a unique No. and its version. The identification number of a
document has the following structure:
<ICS>-<Project No.>-<Document Name>-Version or
<ICS>-<Project No.>-<Equipment ID>-<Document Name>-Version
For Example: - ICS-2102-010-V-01-IQ-R0
Where
ICS- short form of Instrumentation and Control Solutions
Project No. - 2102-010-V
01-is a first document no. of system in the Project.
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VALIDATION PLAN

Document Name: IQ, abbreviation for Installation Qualification, which is one of the project relevant
document. Document name can be varied according to the deliverables.
Version- R0 is version number, if a particular document is repeated due to any reason for same PO, the
version number shall be changed in sequence R1, R2, R3…..and so on.
Equipment ID- it is the ID of system/equipment/Instrument which will be going for the validation.
Note: if any documents revised due to any reason, previous project code shall be applicable.
13. Validation Approach
Validation shall be used as a tool for providing a high degree of assurance that a specific process
control system consistently produces a product meeting its pre-determined specification and quality
attributes.
For the validation, GAMP 5 guidelines have been considered. As per GAMP Software Life Cycle
approach and V-Model considered for all automated control systems. The following table depicts
categorization of various software systems as per GAMP 5.
The system categorization is intended to evaluate and determine appropriate validation activities and
deliverables. Once a system is evaluated as a whole, the functionality of individual components can be
assessed for potential risk to data integrity and tested accordingly. In determining the system
categorization, functionality and intended use of the system are to be considered
Category Software Type Validation Approach

 Record version number
1 Infrastructure Software  verify correct installation by following approved
installation procedures
 Abbreviated Lifecycle approach
 Risk based approach to supplier assessment
Non-configured Software  Record version (and configuration of
e.g. Firmware based application environment) and verify correct installation.
3
COTS software  Risk based tests against requirements (calibrations
Instruments for instruments)
 Procedures in place for maintaining compliance
and fitness for intended use.
4 Configurable Software Packages  Life Cycle approach
e.g.  Risk based approach to supplier assessment.
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VALIDATION PLAN

Category Software Type Validation Approach

 Record version number, verify correct installation
SCADA
 Risk based testing to demonstrate applicable
ERP
works as designed in a test environment and
DCS
within the business process.
BMS
 Procedure in place for maintaining compliance
LIMS
and fitness for intended use.
 Procedures in place for managing data.
Custom Software e.g. internally Same as configurable, plus:
or externally developed IT  More rigorous supplier assessment.
5 applications.  Possession of full life cycle documentation
Custom ladder logic  Design and source code review
Spreadsheets (macro)
13.1 Life Cycle Model

Validation shall be used as a tool for providing a high degree of assurance that a specific process
control system consistently produces a product meeting its pre-determined specification and quality
attributes.
The validation documentation shall cover life cycle management approach for all process control
systems.
The validation exercise will follow the typical ‘V’ diagram approach as advocated by GAMP5. The
diagram is shown below as reference:
The model suggests that after completion of first validation exercise, Computerized System shall be
governed by formal change control process during operation phase. All changes shall follow the ‘V’
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VALIDATION PLAN

model depending upon the impact assessment. After completion of use of the system, the same will be
retired following a defined retirement plan.
14. Categorization of the Control System
14.1 Hardware Category

 Hardware Category 1 - Standard hardware component
14.2 System Categorization

 The system software fall under category 4 as per GAMP-5.
GxP Regulated System Yes (√) No (-)

Electronic Record Relevance Yes (√) No (-)
Electronic Signature relevance Yes (√) No (-)
Comments (if any):NA
15. Validation Deliverables
Following activities will be undertaken during the validation project.
15.1 Initial Risk Assessment
The IRA defines the Risk Assessment for GxP Assessment and software and hardware
Definition Categorization to identify and document that PLC and SCADA based system of Rapid
Mixer Granulator (TRMG-10) is determinate the GxP criteria. Categorization as per
Phase IRA.
Planning
Control M/s. Abbott Healthcare Private Limited, will maintain and control this document.
Reviewer Engineering, Information Technology and QA Department
Approver QA Department
15.2 Validation Plan
Definition This document serves as the Validation Plan to detail activities to be undertaken, and
to define criteria under which the system may be approved for use. Preparation of the
Validation Plan to define the strategy of validation, V-model to be used for the
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VALIDATION PLAN

validation approach is adapted from GAMP-5.
Phase Planning
15.3 System Requirement Specification
The SRS defines the ‘intended use’ of a system from a system requirement
perspective. It is expected this document should contain following items:
Definition
 System Overview
 Brief System Requirements
Phase Specification
15.4 Functional Risk Assessment

This document is to provide the functions of the system against the system
Requirements will be assessed for its level or Risk and documented in Functional
Risk Assessment. The areas that are covered in the Functional Risk Assessment are
Definition
patient safety, product quality, data integrity, system security, regulatory compliance
and intended usage. The criteria that are used as basis for risk assessment are GxP
criticality, severity, probability and detectability.
Phase Specification
Control M/s. Abbott Healthcare Private Limited will maintain and control this document.
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VALIDATION PLAN


15.5 Installation Qualification
The objective of the installation qualification test is to verify the function of PLC and
SCADA based system Rapid Mixer Granulator (TRMG-10).
This includes the following tests but not limited to:
 Verification of Equipment’s Details

 Verification of Master Documents
Definition  Verification of Hardware Components and PC Details
 Verification of Software Components
 Verification of Physical and Logical Security Control
 Verification of Power Utility
 Verification of Environment Condition
 Verification of Security challenges
 Verification of Standard Operating Procedure.
Phase Verification
Executor Instrumentation And Control Solutions Validation Team
Approver QA
15.6 Operational and Performance Qualification
Definition The objective of the operational qualification test is to verify the function of PLC and
SCADA based system Rapid Mixer Granulator (TRMG-10).
This includes the following tests but not limited to:
 Verification of instrument calibration details.
 Verification of PLC Operation.
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VALIDATION PLAN

 Verification of Start-Up and Shutdown procedure of SCADA system.

 Verification of PLC Input/output.
 Verification of User Access Rights.
 Verification of Password policy and Security.
 Verification of Set Parameter Boundary Condition.
 Verification of Power Failure Condition.
 Verification of Communication Failure Condition.
 Verification of Alarms and Interlocks.
 Verification of Data Backup and Restoration.
 Verification of Audit Trail.
 Verification of Control Loop Test.
Phase Verification
Executor Instrumentation and Control Solutions Validation Team
Approver QA
15.7 Requirement Traceability Matrix

The Requirement traceability matrix is to provide the assurance that mapped between
Definition SRS and IQ or OQ. The traceability matrix contains all the traceability mentioned in
system requirement specifications.
Phase Reporting
Approver QA
Acceptance M/s. Abbott Healthcare Private Limited will maintain and control this document.
15.8 Validation Summary Report

This validation summary report is to summarize the sufficient data and the
Definition
qualification executed pertaining to the Validation of PLC and SCADA based system
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VALIDATION PLAN

Rapid Mixer Granulator (TRMG-10). This report describes the successful validation
qualification for the system.
Phase Reporting
Approver QA
Acceptance M/s. Abbott Healthcare Private Limited will maintain and control this document.
16. System Maintenance / Operation and Support Phase

Once the system has been validated and released for use in operation, appropriate operational
processes, procedures and plans shall be implemented during operational phase to maintain compliance
and fitness for intended use throughout its life. This will be achieved by the use of up to date
documented procedures and training that cover use, maintenance and management.
The System Maintenance phase shall embody all maintenance and support activities necessary to
ensure that the validated status of the system shall be maintained throughout its operational life and this
shall be the responsibility of the M/s. Abbott Healthcare Private Limited site operating/ maintenance
personnel.
16.1 Standard Operating Procedures

During the operation phase various types of Standard Operating Procedures shall be created to maintain
and support the Production systems to remain in validated state. Each SOP is summarized briefly
below:
Sr.
SOP Name Description
No.
CAPA is a process for investigating, understanding, and correcting
Corrective and
1. discrepancies while attempting to prevent their recurrence and for
Preventive Action
recognizing potential discrepancies to prevent their occurrence.
Describes the procedure of backup of records, data and software to

2. Data Backup, Restore
protect against loss of integrity or availability of the original, describes
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VALIDATION PLAN

Sr.
SOP Name Description
No.
how system generated data can be restored from the backup and archive
media.
Changes to the system in operational phase shall be handled through
Change Control standard change control procedure. The scope of the validation effort
3.
Procedure will be assessed depending upon the nature of change in validated
system and its associated risk /impact.
Archiving and Describes how system generated records and data are taken off-line by
4.
retrieval moving them to a different location or system
16.2 Periodic review

In order to maintain the validation and GxP status of instrument software, all validated systems shall be
reviewed in requirement basis, in order to evaluate the trends in performance or changes in the
operating environment in which software operates.
Periodic review shall be performed/ conducted throughout the operational life of SLC as per defined
procedure.
During the validation review, documents and change control history shall be reviewed. The results of
the review shall be documented, which will conclude either that the validation status is upheld or that
revalidation is required.
During periodic review following are verified but not limited to this only
 Status of validation documentation and updates

 Status of IT SOPs and updates
 Status of Qualifications
 Status of Authorizations
 Status of affected Operational SOPs for the changes.
 Training Records (As per the Training SOP)
 Change Controls
 Problem (Production Incident) Logs review
 Review of updates in regulations/ guidelines
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VALIDATION PLAN

16.3 Patch Management

Appropriate management of patches & updates is important for every computer system to maintain its
fitness and compliance for intended use. Any patch or update can be applied to computer systems after
analyzing the risks that may be present to the current working of the system. Appropriate change
controls procedures must be followed for patch and update management. All configuration and other
applicable validation documents will have to be updated after the application of patches & updates.
16.4 Change Control

Change control is a critical activity that is fundamental to maintaining the complaint status of systems
and processes. All changes that are proposed for a Production Systems, whether related to software,
hardware or use of the system, should be subject to a formal change control process. This process
should ensure that proposed changes are appropriately reviewed to assess impact and risk of
implementing the change. The process should ensure that changes are suitably evaluated, authorized,
documented, tested and approved before implementation and subsequently closed. Changes that can
impact product quality may require full or partial revalidation of the Production System. The process
should allow the rigor of the approach, including the extent of documentation and verification, to be
scale based on the nature, risk and complexity of the change. Some activities such as replacements and
routine tasks should be covered by appropriate maintenance.
16.5 Training
The Project Team Members, users, and Support Personnel responsible for the validation, use,
administration, and/or maintenance of the system will be required to have the appropriate qualifications
and/or receive adequate training prior to performing their roles and responsibilities for the project.
All personnel who will participate in the validation, use, administration, and maintenance of the system
will be trained (or have been previously trained) with particular focus on their roles and responsibilities
during Validation and business activities.
The following types of training will be provided during the project:
 Manual & Training (including SOPs and other types of procedures)

 IT System User Training (including System Training)
 System Administration/Maintenance Training (including System Training)
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VALIDATION PLAN

The qualification and training records for all personnel who will participate in the validation, use,
administration, and maintenance of the system will be maintained as defined in the Training procedure.
17. Revalidation
Revalidation of the Systems will be carried out as per Computer system Validation Master Plan or as
and when required. Recommended Criteria for Revalidation are given below. However final decision
should be based on risk assessment of change.
 Every 5 years ± 6 months (As per CSVMP Planner)
 Major changes, which also impact the structure
 Major system faults
 New hardware and/or software added to existing system.
 New functionality added to the existing system.
A detailed list of various scenarios which required full validation /partial/ No validation will be
prepared at the end of the project for future reference of revalidation Activity.
18. Retirement Phase

At the end when a validated Computerized System is retired, a Retirement Protocol shall be generated.
The retirement process will also be applicable for any software and hardware upgrade and previous
version will be made obsolete of following process of retirement.
During system retirement the following steps should be taken.
 A change control should be initiated for the system according to the latest change control
procedure.
 The Retirement Protocol shall be generated and it shall give a general description of the system, its
history and why it is being taken out of use.
 Collecting and reviewing all system documentation that may be necessary to demonstrate
compliance of the system.
 Create a documented evidence of actions taken during decommissioning and retirement of system.
These documents should be retained.
 GxP records are to be maintained with their required retention periods and list out the records
which are destroyed.
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VALIDATION PLAN

 Make sure that the new system will be able to retrieve data from the previous system and the
applications can run on the new system. If the system data is not transferred onto a new System, it
shall be backed up and retained for a longer period of time.
 A backup of the system software and a copy of system documentation shall be retained and stored
with the Retirement Protocol for a defined period of time.
 An archive report shall be generated describing the archive approach and listing documents raw
data and electronic records archived.
19. Abbreviation
ABBREVIATION FULL FORM
EU European Union
FDA Food and Drug Administration
GAMP Good Automated Manufacturing Practices
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-
PIC/S
operation Scheme
CFR Code for Federal Regulations
Good ‘x’ Practice, where ‘x’ is one of: Clinical, Distribution, Production ,
GxP
Manufacturing or Engineering.
ID Identification
IT Information Technology
IQ Installation Qualification
OPQ Operational and Performance Qualification
QA Quality Assurance
SME Subject Matter Expert
SOP Standard Operating Procedure
SRS System Requirement Specifications
FRA Functional Risk Assessment
VP Validation Plan
BMS Building Management System
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VALIDATION PLAN

ABBREVIATION FULL FORM

OS Operating System
SCADA Supervisory Control and Data Acquisition
ICS Instrumentation and control solutions.
AHPL Abbott Healthcare Private Limited
Page 22 of 22

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VALIDATION PLAN

M/s. Abbott Healthcare Private Limited, Baddi

Equipment Name Rapid Mixer Granulator

Equipment ID: TRMG-10

M/s. Abbott Healthcare Private Limited, Baddi

M/s. Abbott Healthcare Private Limited, Baddi

1. Preparation and Approvals

M/S. Instrumentation and control solutions.

Prepared By Name Designation Signature Date

Reviewed By Name Designation Signature Date

Approved By Name Designation Signature Date

M/s. Abbott Healthcare Private Limited, Baddi

M/s. Abbott Healthcare Private Limited, Baddi

M/s. Abbott Healthcare Private Limited, Baddi

Programmable Logic Controller (PLC)

M/s. Abbott Healthcare Private Limited, Baddi

Supervisory Control and Data Acquisition (SCADA)

7.2 System Architecture

M/s. Abbott Healthcare Private Limited, Baddi

8. Role and Responsibility

User Department (M/s.  To review Validation Plan document.

Engineering (M/s. AHPL)  To review Validation Plan document.

IT (M/s. AHPL)  To review Validation Plan document.

QA (M/s. AHPL)  To review and approve Validation Plan document.

M/s. Abbott Healthcare Private Limited, Baddi

M/s. Abbott Healthcare Private Limited, Baddi

10. Documentation Procedure

M/s. Abbott Healthcare Private Limited, Baddi

Category Software Type Validation Approach

M/s. Abbott Healthcare Private Limited, Baddi

Category Software Type Validation Approach

13.1 Life Cycle Model

M/s. Abbott Healthcare Private Limited, Baddi

14.1 Hardware Category

14.2 System Categorization

GxP Regulated System Yes (√) No (-)

15.1 Initial Risk Assessment

Reviewer Engineering, Information Technology and QA Department

15.2 Validation Plan

M/s. Abbott Healthcare Private Limited, Baddi

validation approach is adapted from GAMP-5.

Reviewer Engineering, Information Technology and QA Department

15.3 System Requirement Specification

 Brief System Requirements

Reviewer Engineering, Information Technology and QA Department

15.4 Functional Risk Assessment

M/s. Abbott Healthcare Private Limited, Baddi

Reviewer Engineering, Information Technology and QA Department

15.5 Installation Qualification

 Verification of Equipment’s Details

15.6 Operational and Performance Qualification

M/s. Abbott Healthcare Private Limited, Baddi

 Verification of Start-Up and Shutdown procedure of SCADA system.

15.7 Requirement Traceability Matrix

15.8 Validation Summary Report

M/s. Abbott Healthcare Private Limited, Baddi

16. System Maintenance / Operation and Support Phase

16.1 Standard Operating Procedures

Describes the procedure of backup of records, data and software to