Services: Offerings: Regulatory Assessment and Validation


Regulatory Assessment and Validation

Tribiosys provides technology-based services pertaining to international regulatory compliance (e-submissions, Computer System Validation, 21CFR Part 11/ HIPAA, ICH guidelines, Common Technical Text Box:  Document). Services include validation and 21 CFR Part 11 gap analysis, mitigation/redeployment/remediation, master and system-specific planning, training and SOP development, and archival, storage and retrieval solutions for current and legacy software environments. The Tribiosys 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, Tribiosys has experience planning and managing validation projects including:

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

Tribiosys also has the expertise to design systems that incorporate cGLP, cGMP and cGCP requirements, as well as systems that support compliance to these quality-related regulations.


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