Validation Services

An intrinsic challenge and essential requirement to regulated environments is having a software validation process that ensures both data quality and integrity and also establishes compliance. Genedata has unique expertise in supporting the life science industry in the implementation and validation of IT solutions in GxP environments.

Our validation services include:

  • Validation plan and protocol development
  • Installation Qualification (IQ) and Operational Qualification (OQ) documentation
  • System traceability matrix plan
  • System requirement planning
  • Risk analysis assessment
  • Audit trails supporting full traceability of data and results
  • Method management enabling the implementation of Standard Operating Procedures (SOP) to ensure reproducibility and quality of data handling
  • Workflow and report approval via electronic signatures (FDA 21 CFR Part 11)
  • Implementation support, testing support, personalized training, and consulting services

Genedata follows best practice approaches in software development. Accurate documentation, extensive testing, systematic update handling, and internal quality control ensures that our products are stable and well defined. Genedata uses this same discipline to develop validation strategies as required by FDA guidelines, making our products well suited for use in complex environments such as GxP.

Drawing from an unrivaled combination of experience and knowledge of the life science industry, our validation experts have a deep understanding of the science behind our customers’ workflows. We provide solutions that integrate complex technologies, multiple instrumentation equipment, internal and external software, and business processes.

Our validation services substantially reduce the risks inherent in the transfer of projects from discovery into regulated environments. This expertise also helps customers to reduce both the time and the cost associated with validation processes.