USDM

 

USDM laboratory consulting professionals are experts in Computer Systems Validation (CSV). Our goal is to simplify, unify and optimize the Computer Systems Validation paradigm to achieve cost-effective, yet compliant Computer Systems Validation packages for our customers.

We achieve this through:

• Experience – decades of computer systems installation and computer systems validation projects.
• Risk-based approach to computer systems validation – a tried and tested method where the focus of the CSV is on critical functions and modules that impact compliance data.  All other functions that indirectly affect compliance data are minimally tested.  This is documented in a detailed Risk Assessment.
• Validation Accelerator Packs (VAPs) for most standard lab systems.  These VAPs are a complete set of content-rich validation document templates for the system based on common, core requirements for life science companies.

• Infrastructure
• A variety of functional areas / practices
• Simple to complex computer systems
• Different GAMP 5 categories of computer systems validation:
  • Category 1: Infrastructure Software
  • Category 3: Nonconfigured products
  • Category 4: Configured products
  • Category 5: Custom applications

Furthermore, we have set up validation / compliance procedures and programs for numerous clients.

Some of the typical documentation deliverables provided as part of a Computer Systems Validation project are:

• Computer System Validation Plan
• Risk Assessment
• User Requirements Specification
• System Requirements Specification (Functional Requirements Specification)
• Design Documentation
• Test Protocols such as:
  • UAT
  • IQ, OQ, PQ
  • FAT, SAT
  • Data Migration Protocols
• Traceability Matrix
• Standard Operating Procedures
• Validation Summary Report