IT Infrastructure Qualification and Maintenance

GxP IT infrastructure must be documented, qualified, and maintained in a controlled state to meet regulatory expectations and industry best practices. We provide end-to-end infrastructure qualification and maintenance solutions tailored to your environment, whether on-premises, cloud-based, or hybrid.

•  Infrastructure Qualification Planning & Execution for AWS, Azure, on-premises, and hybrid environments.

• Location Risk Assessments for data centers, MDF/IDF rooms, and vendor-hosted environments.

•  IT Change Management & Periodic Review Processes to ensure infrastructure remains in a controlled state.

Our Infrastructure Compliance Library provides your organization with the tools needed to align infrastructure maintenance and qualification programs with regulatory requirements and industry best practices. This includes:

• Infrastructure Qualification Plans and Test Protocols (IQ/OQ/PQ).

• Infrastructure Management SOPs (Backup, Restore, Disaster Recovery, IT Change Management, Security, Incident Response, IT Access).

• Work Instructions for Configuration Items (Servers, Virtual Machines, Storage, Network Devices, Cabling, Power Devices).

• Risk Assessment Templates for Data Centers, Vendors, and IT Systems.

• Traceability Matrices, Configuration Specifications, and Installation Instructions.

With this comprehensive compliance solution, you can establish and maintain a structured, audit-ready IT infrastructure that meets regulatory requirements while supporting operational efficiency.