Life cycle csv

1. LIFE CYCLE MANAGEMENT OF
COMPUTERIZED SYSTEM
RAKTIM DEY
DY. MANAGER-VALIDATION AND QUALIFICATION
GRANULES INDIA LIMITED

2. OVERVIEW
Life cycle management of Computerized system consists of the following major steps:
• Requirements
• Development
• Validation
• Implementation/Deployment
• Control
• Maintenance and
• Retirement

3. COMPUTERIZED SYSTEM LIFE CYCLE MANAGEMENT FLOWCHART
Change Control
Initiation
Initial Risk Assessment
System Information
Business Requirement
GXP Relevance
ER/ES Relevance
GAMP Categorization
New System or Existing
System or Laboratory
software or Production
Equipment related or Other
control system or etc.
User Requirement
Specification (URS)
• Purpose of the system
• Brief description of the system
• Design and Environment
• Regulatory requirements
• Service Requirement
• References
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4. COMPUTERIZED SYSTEM LIFE CYCLE MANAGEMENT FLOWCHART
Vendor Identification
and Assessment
Identification of Suitable vendor
Vendor assessment through audits as applicable
Finalization of the vendor
Vendor documents DS/FS/CS/operation manual Assessment
Validation Plan
Validation plan explains about how the necessary requirements will be fulfilled.
It will provide the list of life cycle documentation, role and responsibility and
define testing strategy, criteria for final acceptance, release of system and
maintenance of lifetime compliance.
Validation of computerized system shall be performed in a logical, systematic
manner and risk based approach shall be followed.
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5. COMPUTERIZED SYSTEM LIFE CYCLE MANAGEMENT FLOWCHART
System Installation
Qualification
Type of Environment – Validation Server or Production Server
System Details like Software name, Version,
Installation Checklist (Installation of Instrument/Equipment,
Installation and Configuration of Application Software
Verification of Pre-Installation Checklist (PO, Intactness of system
components, etc.)
Deviation record, if any.
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6. COMPUTERIZED SYSTEM LIFE CYCLE MANAGEMENT FLOWCHART
System Installation
Qualification
Type of Environment – Validation Server or Production Server
System Details like Software name, Version,
Installation Checklist (Installation of Instrument/Equipment,
Installation and Configuration of Application Software
Verification of Pre-Installation Checklist (PO, Intactness of system
components, etc.)
Deviation record, if any.
Summary and conclusion
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7. COMPUTERIZED SYSTEM LIFE CYCLE MANAGEMENT FLOWCHART
System Operation
Qualification
Roles of different personnel involved in the qualification of system
Reference documents to perform OQ
Test Planning [Test Items, Components and functions to be tested]
Test Strategy [Test Objective, Test Approach, Recording of results,
Acceptance criteria]
Deviation record, if any
Summary and conclusion
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8. COMPUTERIZED SYSTEM LIFE CYCLE MANAGEMENT FLOWCHART
System Performance
Qualification
Roles of different personnel involved in the qualification of system
Reference documents to perform PQ
Test Planning [Test Items, Components and functions to be tested]
Test Strategy [Test Objective, Test Approach, Recording of results,
Acceptance criteria]
Deviation record, if any
Summary and conclusion
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9. COMPUTERIZED SYSTEM LIFE CYCLE MANAGEMENT FLOWCHART
Validation
Summary Report
Objective: The objectives of this VSR are to summarize the results
of the validation effort for <Computerized system> to show that
the system is validated according to standards and applicable
regulatory requirements.
Deviations from the Validation Plan, if any
Follow up actions w.r.t the deviations
Summary and Assessment of System Life Cycle Documentation,
e.g. Name Document ID
User requirement Specification To record
Initial Risk Assessment To record
Validation Plan To record
Function Specification To record
Traceability Matrix To record
Risk Assessment (FMECA) To record
Post Implementation review, System acceptance and release
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10. COMPUTERIZED SYSTEM LIFE CYCLE MANAGEMENT FLOWCHART
Traceability
Matrix
URS ID
URS specification or
Parameter
IQ test ID OQ test ID PQ test ID
Remarks
If any
URS-01
URS-02
URS-03
URS-04
Traceability matrix outline the User Requirement and the section in which
that particular requirement is tested.
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11. COMPUTERIZED SYSTEM LIFE CYCLE MANAGEMENT FLOWCHART
Post
Implementation
Review
Validation Documents Review
Deviation/Change Record Review
Audit Trail Record Review
System Security and Access Control Review
Software and Data Backups Review
Training Record Review
SOPs Review
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12. COMPUTERIZED SYSTEM LIFE CYCLE MANAGEMENT FLOWCHART
Periodic Review
Sr.
No.
Name of Computerized
System
Version no.
/Release no.
Frequency of
Review
Date of
Validation
Last Periodic
Review done
on
Next Periodic
Review due
on
Periodic
Review
done on
Periodic
Review
Report No.
Periodic Review of system shall be conducted every year, to assess the continuity of
system operation. Any upgradation/Change in the system shall be assessed for re-
qualification
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13. COMPUTERIZED SYSTEM LIFE CYCLE MANAGEMENT FLOWCHART
Revalidation Any major Changes/ Upgradation in the system needs to be re-validated.
System
Retirement
Any system which has gone outdated /Non-Functional needs to be obsoleted through
proper documentation. A risk assessment may be performed to assess the impact on
the particular system retirement on Product/Business continuity/Output etc.
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14. THANK YOU