GxP Cloud – Operating and Maintaining

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GxP Cloud – Operating and Maintaining

The IT Infrastructure may change frequently.   The IT Infrastructure should be maintained in a documented state of control.  The following are the recommended procedures and policies to accom0lish this objective.

Infrastructure Qualification Key Procedures



Change Control and Configuration Management

Change Control and Configuration Management go hand-in-hand.  Both should be considered when reviewing a proposed change.

Since change is much more fluid in the Cloud environment, make sure you clearly define your scope.   

Security Management

Security Management should include the policies, procedures, requirements, training, and audit programs., Lack of security may compromise availability of applications and services, record integrityand confidentiality, reputatiowith stakeholders, and may lead to unauthorized use of systems that would ultimately impact product quality.

Backup and Restore

This should describe the procedures for backing up your environment.  Also should describe your testing procedures for restoring the environment.

Disaster Recovery

Describes the procedure if you lose a server, data center, etc.  This procedure, like your Backup and Recovery Procedure, should be tested.

Performance Monitoring

Describes the process and tools for monitoring your network and infrastructure.  Should also describe any standards and tools.

Problem and Incident Reporting

Describes the process for reporting and tracking problems and incidents.  Should include  any references t tools utilized.  

Records Retention and Archival

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Periodic Review

Defines the methodology and scope for performing periodic reviews.  Should identify the validated state of the environment as well as any remediation actions.

Supplier Management

Describes the procedure and policies for managing vendors including adding new vendors to the approved list.

Our SOP Fast-Track includes ALL of these SOPs and more!

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