---
title: "How to Keep Computerized Systems in the Operational Phase"
description: "Validation doesn’t stop when a computerized system goes live. Discover the key practices for keeping your systems validated, reliable and secure throughout the operational phase. Learn how to maintain compliance, data integrity and operational efficiency in a GxP-regulated environment."
url: https://qbdgroup.com/en/whitepapers/how-to-keep-computerized-systems-in-the-operational-phase
type: "White paper"
language: en
published: 2025-03-03
category: "Software Services & Solutions"
publisher: "QbD Group"
citation: "QbD Group, \"How to Keep Computerized Systems in the Operational Phase\", https://qbdgroup.com/en/whitepapers/how-to-keep-computerized-systems-in-the-operational-phase"
---
# How to Keep Computerized Systems in the Operational Phase
> Validation doesn’t stop when a computerized system goes live. Discover the key practices for keeping your systems validated, reliable and secure throughout the operational phase. Learn how to maintain compliance, data integrity and operational efficiency in a GxP-regulated environment.

Discover the key practices for keeping your systems validated, reliable and secure throughout the operational phase.

Learn how to maintain compliance, data integrity and operational efficiency in a GxP-regulated environment.

## About This White Paper

Computerized systems play a critical role in life sciences, supporting everything from data management and record-keeping to essential business and GxP processes. While validation during the project phase establishes a system’s validated state, maintaining that state throughout operational use requires continuous attention.

This white paper explores the key practices for keeping computerized systems under control throughout the operational phase, from a structured handover and effective support services to monitoring, incident management, CAPA and change management.

It also covers periodic reviews, backup and recovery, business continuity and security management, helping you maintain reliable, secure and compliant systems throughout their operational lifecycle.

## Key Takeaways

✓ **Manage the Transition From Project to Operations.** Learn how a structured handover can help safeguard the validated state through documented release, completed data migration, updated configuration items, knowledge transfer and an appropriate hypercare period.

✓ **Establish Effective Support Services.** Understand how formal service agreements and clearly defined responsibilities help manage internal and external support, including software updates, infrastructure services, IT security, maintenance, backup and recovery.

✓ **Monitor System Performance and Risks.** Discover how system monitoring can identify failures, availability issues, performance problems and security threats early, with monitoring activities based on business risks, patient safety, product quality and data integrity.

✓ **Handle Incidents and Problems Systematically.** Learn the difference between incident and problem management, and how established procedures can support timely resolution while identifying and addressing root causes.

✓ **Use CAPA to Correct and Prevent Issues.** Explore how Corrective and Preventive Actions can address immediate problems, investigate root causes and reduce the likelihood of recurrence while considering patient safety, product quality and data integrity.

✓ **Control Operational and Configuration Changes.** Understand why effective change and configuration management are essential for maintaining computerized systems and minimizing the risk of disruption when applications, infrastructure, data or business processes change.

✓ **Perform Periodic Reviews.** Learn how periodic reviews help determine whether your system remains in a validated state and whether changes affecting data integrity, regulatory requirements or intended use require revalidation.

✓ **Prepare for Backup, Recovery and Business Continuity.** Discover why documented and tested backup and restoration procedures, Business Continuity Plans and Disaster Recovery Plans are essential for maintaining operations and recovering from system failures, data corruption, cyberattacks and other disruptions.

✓ **Keep Security Under Control.** Explore practical measures such as regularly reviewing policies, performing backups, conducting security audits and preparing for cyber threats to keep computerized systems secure throughout operational use.
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Source: https://qbdgroup.com/en/whitepapers/how-to-keep-computerized-systems-in-the-operational-phase — © QbD Group. Quote freely with attribution and a link back.