Computer Systems Validation Services

Labnetworx provides Computer Systems Validation services for pharmaceutical, biotechnology, food, tobacco and medical device companies. We employ proven methodologies and best practices around quality and project management, with an experienced staff that has developed and refined these practices over many years via complex projects. 

We provide technology-based services pertaining to international regulatory compliance for regulatory agencies such as FDA, EMA. Services include validation and 21 CFR Part 11 gap analysis, mitigation / redeployment / remediation, master and system specific planning, training & SOP development, as well as archival, storage and retrieval solutions for current and legacy software environments.

The Labnetworx computer systems validation approach integrates industry standard software development life cycle (SDLC) and software quality assurance (SQA) methodologies with relevant validation compliance best practices. 

Specifically, Labnetworx has experience planning and managing validation projects, including:

  • Validation to GLP, GCP, GMP standards
  • Gap Analysis and Risk Assessment
  • Development of Validation Documentation Suites including Validation Master Plan, URS and FRS
  • Traceability Matrix, Policies, SOPs, Work Instructions
  • Validation Protocols & Reports (IQ,OQ, PQ)
  • Change Management and maintaining a continuous validated state
  • Rollout of validated applications to additional sites

Contact Us

For more information about our audit services, please email at info@labnetworx.com
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