Inspection Readiness for Computerised System

Pharmaceutical, Medical Device and Process Industries are Survive the Regularity Audits, They always have audits / inspections to ensure regulatory and quality compliance. 

Regulatory inspection are unpredictable for these above mentioned industries because this could affect the authorization to produce any new / existing drug to supply in the new/existing market. Use this checklist and ensure the availability of current documents.

Inspection Readiness check list.

ü  Change Control Initiation and approval status.

ü  URS Initiation and approval status.

ü   Project Plan (schedule)

ü  GxP Assessment & System Categorization

ü  System Level Risk Assessment

ü  Vendor Survey

ü  Vendor Onsite Audit

ü  Vendor OFF site Audit

ü  Vendor Audit Report

ü  Project Validation Plan

ü  Training Records

ü  Functional Specification

ü  Software and Hardware Design Specification

ü  Functional Risk Assesment

ü  Configuration Specification

ü   Software Code Review

ü  Test Plan

ü  Hardware Qualification

ü  Infrastructure Qualification

ü  Installation Qualification

ü  Operational Qualification

ü  Performance Qualification

ü  Test Report

ü  Requirement Traceability Matrix

ü  Discrepancy Form & Its Logs

ü  Data Migration Plan

ü  Signature Identification Log

ü   System Specific Business & Technical SOPs

ü   Validation Summary Report

ü  System Release Certificate

ü  Change Control Closure

ü  System Retirement & Decommissioning

Inspection Readiness of IT Compliance

ü  IT Infrastructure Site Master Plan.

ü   IT Business Continuity Plan .

ü  Disaster Recovery Plan

ü  System Data Back and Restoration Plan

ü  System Data Back and Restoration Procedure

ü  SOP

ü  Roles and Responsibility

ü  Quality Management Procedure and Policy

ü  Change Control Management

ü  CAPA

ü  Deviation Planned and Unplanned

ü  Application System Management

ü  Infrastructure System Management

ü  Server Qualification

ü  Gxp Classification

ü  Risk Assessment

ü  Policy and Procedure

ü  Personal Record

ü  Identified GAP

ü  Action Plan

ü  System Inventory List

ü  User Management

ü  System Configuration Management

ü  Change Management

ü  Release Management

ü  Patch Management

ü  Information Security Policy

ü  Release & Deploy

ü  Evidence of implementation (records)

ü  Cyber security – Addressing Malicious Threats to the Life Science Industry

ü  Develop an IT Infrastructure and Network Qualification Roadmap

ü  IT Facility Management

ü  Critical protocol deviations

ü  Audit (Vendor and Assessment)

ü  An internal audit and review your Quality Management System.

ü  Policies

ü  Qualification

ü   Computer System Validation

ü  Way of Working

ü  Application

ü  Internal and External Audit Preparation

ü  Role and Responsibility

ü  User Management

       Computerized System Prospective System (New System)

    ü  User Management

ü  Gxp Assessment

ü  Risk Assessment

ü   Data Back up and Restoration Procedure

ü  Business Continuity Plan

ü  Validation Approach

ü  Change Control

ü  Dual effort between IT and Business System Owners

ü  Vendor Assessment (Purchase)

ü  Periodic Review and Validation

ü  Retirement Plan

Computerised System Legacy System (Old System) 

 ü  Gxp Assessment

ü  Risk Assessment

ü   Data Back up and Restoration Procedure

ü  Business Continuity Plan

ü  Validation Approach

ü  Change Control

ü  Dual effort between IT and Business System Owners

ü  Vendor Assessment (Purchase)(Logic Change and  Up gradation)

ü  Establish an Inventory List of all current systems

ü  System documentation like Validation Plan, Requirements Specification, 

Test documentation, Validation Report, Operating Manual..)

ü  Supporting processes IT QMS and System Owner (SOP’s to operate and support validated state)

  Mock Inspection

 ü  Training and Personal Record

ü  RH and Temperature Maintain log and System area

ü  Identifying GAP and Risk

ü  Periodic Review