Retiring GxP Systems Without a Compliance Nightmare
Retiring or decommissioning a system in a regulated industry isn’t as easy as flipping off a switch. Data integrity and GxP compliance are just as important now as they were throughout the system’s life, and the risk of penalties for non-compliance are just as high. That’s why companies must ensure they follow the right steps when decommissioning a system.
Ensure that you know and follow all of your company’s decommissioning policies.
File a formal change control request to initiate the process and ensure that the System Owner, IT, Quality Assurance, and compliance and security teams are aware and involved in the process from the beginning.
Identify all the GxP data stored in the system and determine data retention requirements for each type of data based on regulatory guidelines. Use this information to develop a migration/archive strategy that ensures compliance.
Perform an assessment of the impact the decommissioning will have on ongoing operations, audits, and any system interfaces or dependencies.
Ensure the most critical data is backed up and archived following the proper archival procedure. Additionally, you should retain all supporting documents that are related to the system (URS, deviation logs, validation records, etc.)
If the data is to be migrated, make sure to follow a validated process that does the job completely and accurately.
Properly dispose of all IT equipment to prevent data breaches: revoke user access, lock system functions, and shut down servers. Continue to follow cybersecurity risk management strategies because threats can remain even if the system is retired.
Be aware that audit access may be required years after the system is retired. That means you must maintain data integrity, availability, and traceability for years to come to avoid any penalties.
When the time comes to decommission your GxP-compliant system, it’s important to take steps to protect the data integrity and security of the out-going system. Having a thoughtfully developed strategy and following the above guidelines will protect you from the nightmare penalties of falling out of compliance.