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Standard Operating Procedure

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6 views

Standard Operating Procedure

Uploaded by

dipanray1997
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Standard Operating Procedure

Title: Computer System Validation (CSV) for System Implementation and Maintenance

SOP Number: CSV-001


Effective Date: [Insert Date]
Version: 1.0
Approval By: [Insert Name/Title]

1. Purpose The purpose of this SOP is to define the process for validating computer systems
to ensure they meet their intended use and comply with applicable regulatory requirements
(e.g., FDA 21 CFR Part 11, EU Annex 11).

2. Scope This SOP applies to all computer systems used for GxP-related activities, including
but not limited to systems used for manufacturing, laboratory operations, and quality
management.

3. Responsibilities

 System Owner: Ensures the system meets business and compliance requirements.
 Validation Team: Conducts validation activities and documents results.
 IT Department: Provides technical support and implements system configurations.
 Quality Assurance (QA): Reviews and approves all validation documentation.

4. Definitions

 Validation: Documented evidence that a system performs its intended functions


consistently and reliably.
 User Requirements Specification (URS): A document that defines the functional
requirements of the system.
 IQ (Installation Qualification): Verification that the system is installed as per
specifications.
 OQ (Operational Qualification): Verification that the system operates as intended
under specified conditions.
 PQ (Performance Qualification): Verification that the system performs effectively
and reproducibly in a real-world environment.

5. Procedure

5.1 Planning Phase


1. Identify the system and its intended use.
2. Assign a validation team.
3. Develop a Validation Master Plan (VMP), outlining:
o Validation scope
o Roles and responsibilities
o Validation deliverables
o Risk assessment methodology

5.2 Requirements Phase

1. Draft a User Requirements Specification (URS).


2. Conduct a risk assessment to identify potential system risks.
3. Develop a Functional Specification (FS) and a Design Specification (DS).

5.3 Validation Phase

5.3.1 Installation Qualification (IQ)

1. Verify the installation of hardware and software components.


2. Document hardware/software configurations.
3. Ensure appropriate access controls are in place.

5.3.2 Operational Qualification (OQ)

1. Develop OQ test scripts based on the Functional Specification.


2. Execute OQ test scripts and document results.
3. Address any deviations or issues.

5.3.3 Performance Qualification (PQ)

1. Develop PQ test scripts simulating real-world scenarios.


2. Execute PQ test scripts and document results.
3. Obtain end-user acceptance.

5.4 Reporting Phase

1. Compile a Validation Summary Report (VSR) that includes:


o Overview of validation activities
o Summary of test results
o Deviations and corrective actions
o Final approval

5.5 Maintenance Phase

1. Perform periodic reviews to ensure continued compliance.


2. Document changes to the system using a Change Control process.
3. Revalidate the system when significant changes occur.
6. Documentation The following documents must be generated and maintained:

 Validation Master Plan (VMP)


 User Requirements Specification (URS)
 Functional Specification (FS)
 Design Specification (DS)
 IQ/OQ/PQ Protocols and Reports
 Validation Summary Report (VSR)
 Change Control Records
 Periodic Review Records

7. References

 FDA 21 CFR Part 11


 EU GMP Annex 11
 GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems

8. Revision History

Version Date Description Approved By


1.0 [Insert Date] Initial Release [Insert Name/Title]

9. Appendix

 Appendix A: Example Test Script Template


 Appendix B: Risk Assessment Template

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