How to Properly Decommission a cGMP System in Compliance with FDA

Decommissioning equipment in a cGMP facility is no small task—it requires careful planning, regulatory compliance, and the right expertise to ensure everything is done safely and by the book. Whether you're shutting down a single production line or an entire facility, partnering with a firm that understands the complexities of cGMP standards, documentation requirements, and proper equipment handling is essential. In this post, we’ll explore what to look for in a decommissioning partner, key steps in the process, and how to ensure a smooth transition that meets both operational and regulatory needs.

Some may assume that system decommissioning is as simple as shutting down and removing a system from service, but it requires a structured approach in regulated environments. Proper decommissioning safeguards critical records, maintains adherence to regulatory requirements, and ensures future accessibility of archived data. This process includes planning, risk assessment, data migration, system verification, and controlled system shutdown.

A well-defined system lifecycle includes:

·         Operation & Maintenance – Ensuring continued compliance, performance, and data integrity.

·         Change Management – Managing updates, patches, and modifications.

·         Decommissioning – Executing a structured process for regulatory compliance, data retention, and secure system shutdown.

For regulated industries, ensuring the accuracy, accessibility, and audit readiness of historical production, holding, and transportation data—as required by 21 CFR Parts 210 and 211—remains a priority even after a system is retired. Without a well-defined decommissioning strategy, organizations risk compliance issues, data loss, and challenges in retrieving records in a human-readable format during audits.

This document explores the decommissioning phase of the cGMP system lifecycle, addressing key challenges such as:

·         Data retention requirements

·         System configuration documentation

·         Audit trails

·         Legacy software accessibility

·         Data integrity risks (ALCOA+)

By proactively planning for system decommissioning, organizations can mitigate risks and ensure seamless regulatory compliance long after a system is retired.

cGMP System Lifecycle: Where Does Decommissioning Fit?

The cGMP system lifecycle follows a structured approach:

1. Concept & Planning – Defining system needs and user requirements.
2. Design & Development – Engineering the system with compliance in mind.
3. Testing & Qualification (IQ, OQ, PQ) – Validating that the system meets intended requirements.
4. Operation & Maintenance – Ongoing use, monitoring, and periodic review.
5. Retirement (Decommissioning & Data Archival) – Ensuring that historical data remains accessible, secure, and compliant.

While most of the industry’s focus is on implementation and validation, decommissioning requires equal planning. Poorly executed system retirements can lead to data loss, compliance gaps, and an inability to retrieve records during audits.

Regulatory Considerations for System Retirement

How Long Should Data Be Retained?

• 21 CFR 211.180 states that CGMP data related to production must be retained for at least one year past the product’s expiration date.
• For OTC products without expiration dates, retention is at least three years after the last distribution.
• However, organizations must assess whether these rules apply to all system data or only production-related records.

Documenting System Configuration at Retirement

Before decommissioning a system, it is essential to capture system configuration settings at the time of shutdown. This ensures that archived data remains accessible and regulatory inquiries can be answered efficiently.

• What should be documented?
• System version & patch level
• User access roles & permissions
• Database structures & storage settings
• Audit trail configurations
• Encryption and security settings
• Retention policies & backup procedures

Without this information, retrieving archived data years later could become impossible, creating compliance risks.

Handling Proprietary Data and Legacy System Accessibility

Legacy systems often store data in proprietary formats, making long-term accessibility a challenge. To address this:

• Convert proprietary data formats into open, standardized formats (e.g., XML, CSV, PDF/A).
• Validate that a virtual machine (VM) running the legacy system can access historical data.
• Implement middleware solutions for data migration if conversion is not feasible.

Hypothetical Example: Retiring an Environmental Monitoring System (EMS)

The Situation

A pharmaceutical company is replacing its Environmental Monitoring System (EMS) used for temperature, humidity, and particle count tracking in an aseptic processing area.

• The current EMS runs on Windows 7, which is no longer supported.
• The new EMS is cloud-based, offering enhanced security and automation.
• The old system must be decommissioned, but historical data (7+ years) must remain accessible.

Key Challenges & Solutions

• Data Retention & Compliance: Retain environmental monitoring data for at least the stability data retention period.
• Ensuring Long-Term Data Accessibility:
• Validate that a virtual machine running Windows 7 can open archived EMS data.
• Perform a test retrieval scenario to confirm that data remains human-readable.
• Audit Trail & Post-Retirement Access:
• Use a validated document management system (DMS) to track and log any post-retirement access to archived data.

Validating Archived Data Before System Shutdown

To prevent compliance risks, organizations should validate that archived data is:

1. Accessible – Perform a Data Retrieval Validation Test using sample records from different time periods.
2. Human-Readable – Convert proprietary file formats into open standards.
3. Secure & Auditable – Ensure post-retirement access is logged with timestamps and user tracking.

Maintaining a Retirement Validation Report

A comprehensive decommissioning report should include:

• System settings at shutdown
• Test results demonstrating archived data can be retrieved unaltered
• Audit trail logs of any post-decommissioning access

Final Thoughts: Future-Proofing System Retirements

cGMP system decommissioning is a critical yet often overlooked part of validation and compliance. Failure to plan properly can lead to:

• Non-compliance with regulatory retention requirements.
• Loss of critical data due to outdated or unreadable formats.
• Challenges during audits if historical records are inaccessible.

By implementing robust validation strategies, organizations can ensure decommissioned systems remain compliant, accessible, and audit-ready for years to come.

About the Author

Jon Edgar is the Commissioning and Qualification Team Lead for the Apex, NC office. He provides qualification and compliance consulting services to the Life Science Industry. Jon currently guides customers through the process of qualifying facilities and equipment used in pharmaceutical manufacturing.

Read  My Hallam Story  

About Hallam-ICS

Hallam-ICS is an engineering and automation company that designs MEP systems for facilities and plants, engineers control and automation solutions, and ensures safety and regulatory compliance through arc flash studies, commissioning, and validation. Our offices are located in Massachusetts, Connecticut, New York, Vermont and North Carolina  Texas, Florida and our projects take us world-wide.