Infrastructure Qualification Procedure – Quality IT

Standard Operating Procedure (SOP) for IT Infrastructure Qualification of Computer System used in cGxP environment at the pharmaceutical company.

Computer System – IT Infrastructure Qualification

1.0   Objective

    •  This Procedure defines the procedure for qualifying and maintaining the qualified status (Qualification) of Computerized Systems (CS) Infrastructure to ensure that Computerized Systems that use that infrastructure and support cGxP processes are maintained in a Secure and Validated state throughout their lifecycle.
    • This procedure includes guidance on the following processes:
      • Specification of CS Infrastructure
      • Qualification of CS Infrastructure
      • Operation of CS Infrastructure

2.0   Scope – Qualification of CS Infrastructure

    • This Procedure applies to CS Infrastructure used by Computerized Systems that support cGxP processes. CS Infrastructure shall be categorized as Software Category 1 ‘Infrastructure’ and includes:
    • CS Infrastructure Components:

      • Physical / Virtual Servers
      • Operating Systems
      • Storage Systems
      • Network Switches, Routers Firewalls
      • Database & Middleware Software
    • CS Infrastructure Tools:

      • Infrastructure Performance Monitoring Tools
      • Anti-Malware (Anti-Virus) Systems
      • Active Directory / Identity Management Tools
      • Client Management Tool (Patch/SW Push Tools)
    • Out of scope:

    • CS Infrastructure Applications not classified as CS Infrastructure Components or Tools are not covered by this Procedure and shall be subject to Computerized Systems Validation planning, reporting, and release.
    • CS Infrastructure Applications Qualification includes, but are not limited to:
      • Ticketing Systems
      • Application-Specific Performance Monitoring Tools
      • Load and Stress Testing Tools
      • CS Asset Management tools

3.0   Responsibility :

    • CS Infrastructure Lead

    • Ensures that an inventory of Infrastructure Assets is maintained and ensures that cGxP Infrastructure Assets are Qualified and controlled. (S)he is responsible for:
      • To prepare the CS Infrastructure Specification
      • Preparation of CS Infrastructure IQ Test Plan and Report
      • Preparation of CS Infrastructure Administration Procedure
    • Technical Owner

    • A Technical Owner is appointed to lead the technical specification, design, implementation, and operation of CS Infrastructure Tools and of classes of infrastructure technology.
    • His/her responsibilities include:
      • To prepare the CS Infrastructure Specifications
      • Preparation of CS Infrastructure IQ Test Plan and Report
      • Preparation of CS Infrastructure Administration Procedure
    • Validation Lead

    • A Validation Lead is appointed for each cGxP Computerized System to lead CSV activities. (S)he is responsible for:
      • Review and approval of CS Infrastructure Specification, Test Cases and Results, and System Administration Procedure
      • Approval of CS Infrastructure IQ Test Plan and Report
    • Quality Assurance Lead

    • A Quality Assurance Lead is the Quality Assurance representative assigned to specific departments/regions/sites/systems to act as the independent QA acceptor of Computer Systems Validation deliverables. He/she reviews and approved the CS Infrastructure Administration

4.0   Procedure – IT CS Infrastructure Qualification

    • CS Infrastructure Specification

    • In the case of classes of infrastructure technology with a Technical Owner, the Technical Owner shall prepare CS Instructure Specification(s) using the template.
    • In the site-specific infrastructure, the CS Infrastructure Lead shall prepare CS Instructure Specification(s) using the template.
    • The CS Infrastructure Specification(s) shall include the following specification and design information depending on the type of infrastructure asset:
    • Physical and Virtual Servers:

      • Processor
      • Memory
      • Storage
      • Network Interface(s)
      • Operating System / Virtualization Product and Version
      • Operating System Hardening Set-up
    • Storage Systems:

      • Storage Capacity
      • Operating System / Firmware Storage
      • Storage Controller
      • Storage Area Network Switch
    • Network Switches, Routers & Firewalls:

      • Network Speed
      • Make and Model
      • LAN and WAN Topology
    • Database and Middleware Software:

      • Product and Version
    • Clients:

      • Processor
      • Memory
      • Storage
      • Network Interface(s)
      • Operating System Product and Version
      • Operating System Hardening Set-up
    • Infrastructure Tools:

      • System Software Parameterization Options
      • System Configuration (components and their versions)
    • The Validation Lead and Technical Owner shall review and approve the Infrastructure Specification(s).
    • The Infrastructure Lead shall maintain his/her Infrastructure Specification throughout the lifecycle of the infrastructure it
  • CS Infrastructure Installation Qualification

    • The CS Infrastructure Lead (or Technical Owner) shall prepare a Test Plan for Infrastructure Installation Qualification (IQ).
    • The Infrastructure IQ Test Plan shall be reviewed and approved by the Validation Lead.
    • The CS Infrastructure Lead (or Technical Owner) shall appoint Test Case Author(s) and Testers to prepare and execute Test Cases for the Installation Qualification (IQ) following
    • CS Infrastructure IQ Test Cases shall review and approved by the CS Infrastructure Lead (or Technical Owner) and Validation
    • The CS Infrastructure Lead (or Technical Owner) shall prepare a Test Report for Infrastructure Installation Qualification (IQ).
    • Validation Lead shall review and approve the Infrastructure IQ Test Report.
  • CS Infrastructure Operational and Performance Qualification

    • Operational Qualification (OQ) and Performance Qualification (PQ) of CS Infrastructure shall be achieved as part of the OQ and PQ of each of the Computerized Systems using the infrastructure.
    • No separate Infrastructure OQ or PQ shall perform.
  • CS Infrastructure Operation and Maintenance

    •  Changes to CS Infrastructure Components and CS Infrastructure Tools shall be controlled.
    • Access to CS Infrastructure Components and CS Infrastructure Tools shall be controlled.
    • The CS Infrastructure Lead (or Technical Owner) shall prepare and maintain System Administration Procedure(s) for his/her CS Infrastructure Assets.
    • The CS Infrastructure System Administration Procedure shall define the processes for operating the CS Infrastructure and maintaining its qualified
    • In the case of CS Infrastructure Tools, the administration procedure shall define the procedure for using the tool and controlling the processes it
    • QA shall review and approve the CS Infrastructure System Administration Procedure.

6.0   Preservation of Records

  • Retain the following records as part of the validation documentation set of the reviewed system, according to the retention requirements.
    • CS Infrastructure Specification
    • CS Infrastructure Installation Qualification Test Plan and Report
    • Infrastructure Installation Qualification Test Case and Results
    • CS Infrastructure Administration Procedure

 

 

 

pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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