Computer System Validation

Basic Concepts of Computer System Validation in
Pharmaceutical Industry

What is Computer System?
Computerized systems are the system which used extensively to capture, analyze, store data, report information and to control equipment and processes in life sciences industry.


Software Validation
Provision of objective evidence that software specifications conform to user needs and intended uses and that the particular requirements implemented through software can be consistently fulfilled

Computer System Validation Cycle
1.     Validation Plan
2.     User Requirements Specifications
3.     Functional Specifications
4.     Design Specifications
5.     System Developments
6.     Installation Qualification (IQ)
7.     Operational Qualification (OQ)
8.     Performance Qualification (PQ)


1. Validation Plan
The plan typically describes work to be done, resources required, methods to be used, configuration management and quality assurance procedures to be followed thought activity.

1.     Scope
2.     Approach
3.     Roles & Responsibilities
4.     Acceptance Criteria



2. User Requirement Specifications
The User Requirements Specification describes the business needs for what users require from the system. URS are written by the system owner and end-users, with input received from Quality Assurance.

1.     Business &User Needs from the system.
2.     Intended Use of the system
3.     Critical Constraints

    3.    Functional Specification
Functional specification that specifies the functions that a system or software must perform which predefined in URS.

1.     Verifies specified function
2.     What data the software should capture
3.      Logic, calculations which used in application.

    4.    Design Specification
Design Specifications describe how a system performs the requirements outlined in the Functional Requirements & User Requirement Specification.

1.     Front End Design
2.     Process design
3.     Database design
4.     Security design
5.     Interface design
6.     Network requirements

    5.    System development
Systems development is the process of defining, designing, testing, and implementing a new software application or program.



    6.    Installation Qualification
The Installation Qualification Protocol verifies the proper installation and configuration of a System. This can include ensuring that necessary application files have been loaded, equipment has been installed, the necessary procedures have been approved, or the appropriate personnel have been trained. 


    7.    Operational Qualification
The Operational Qualification Protocol is a collection of test cases used to verify the proper functioning of a system. The operational qualification test requirements are defined in the Functional Requirements specification. Operational Qualification is usually performed before the system is released for use.
Ø Confirmation that all functionality is present
Ø Confirmation that all feature are working as specified

    8.    Performance Qualification
Performance Qualifications are a collection of test cases used to verify that a system performs as expected under simulated real-world conditions. The performance qualification tests requirements defined in the User Requirements Specification (or possibly the Functional Requirements Specification). 

  



Terminology

            I.                  VALIDATION
Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.

            II.               VERIFICATION
Software verification looks for consistency, completeness, and correctness of the software and its supporting documentation, as it is being developed, and provides support for a subsequent conclusion that software is validated.

            III.           QUALIFICATION
Formal testing to demonstrate that the software meets its specified requirements.




General Concepts

I.                  Validation scope can be limited to the features that will be used by the regulated company.
Explanation
A device manufacturer who chooses not to use all the vendor supplied capabilities of the software only needs to validate those functions that will be used and for which the device manufacturer is dependent upon the software results as part of production or the quality system

II.               Validation must be specific to the regulated company’s planned and documented use of the application
Explanation
The acceptance of vendor supplied validation data in isolation of system configuration and intended use is not acceptable. In isolation from the intended process or end user IT infrastructure, vendor testing is likely to be limited to functional verification only, and may not fulfill the requirements for performance qualification.


III.           Vendor documentation can be used as the starting point for validation
Explanation
If the vendor can provide information about their system requirements, software requirements, validation process, and the results of their validation, the medical device manufacturer can use that information as a beginning point for their required validation documentation. FDA, General Principles

IV.           The regulated company needs to audit the vendors of critical applications and services – depending on risk
Explanation
The audit should demonstrate that the vendor’s procedures for and results of the verification and validation activities performed for the OTS software are appropriate and sufficient for the safety and effectiveness requirements …

V.              Service Level Agreement (SLA) Formal agreements are required to document responsibilities
Explanation
When third parties (e.g.suppliers, service providers) are used e.g. to provide, install,  configure, integrate, validate, maintain (e.g. via remote access), modify or retain a computerised system or related service or for data processing, formal agreements must exist between the manufacturer and any third parties, and these agreements should include clear statements of the responsibilities of the third party.












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