USDM

Qualification of infrastructure is a critical part of meeting rigid Part 11 requirements for the Pharmaceutical, Medical Device and Biotechnical industries.

USDM’s Infrastructure systems implementation and qualification practice focuses on rapid deployment, improved quality and reduced / risk-based qualifications for all of our engagements. We achieve this through:

• Experience – more than a decade of infrastructure qualification projects.
• Risk-based approach to qualification – a tried and tested method where the focus of the qualification is on business critical functions that impact regulated systems data.  All other functions that indirectly affect compliance data are minimally tested.  This is documented in a detailed Risk Assessment.
• Qualification Accelerator Packs (VAPs) for most standard infrastructure platforms.  These VAPs are a complete set of content-rich qualification document templates for the system based on common, core requirements for life science companies.

 
The VAP difference:

Each VAP lists requirements and tests for core system functionality and can be leveraged to build the qualification documentation suite.  The USDM VAPs can decrease both qualification time and qualification costs by 50%, as well as provide for faster implementation time and better system performance.

Among the common functionality (modules) covered in our infrastructure VAPs are:

• Verification that manufacturer’s minimum requirements for hardware are met and documented.
• Verification that manufacturer’s minimum requirements for platform software (operating systems, monitoring systems, automated backup systems, virtual systems, etc.) are met and documented.
• Verification that systems are properly installed and configured.
• Documentation of current configuration, software versions and service packs
• Verification that current system design documentation exists
• Verification that  procedures are in place to ensure control (and assistance with creating or revising procedures that are lacking) including:

                 * System Administration (including roles and responsibilities.

                 * Backup and Restore

                 * Disaster Recovery and Business Continuity

                 * Change Control

                 * System Maintenance

                 * Network management

                 * Service Delivery and Help Desk procedures

                 * System Inventory

                 * System Auditing