Touchstone Technologies Inc

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Regulatory Compliance Consulting and Training
FOR WHEN QUALITY JUST CAN'T WAIT

Consulting Products and Services

21 CFR 11 / CSV & IT

21 CFR 11 & Computerized System Validation (CSV)
CSV Master Plan/Process development

  • Project Management, deliverables development, and execution support
  • CSV documentation audits
  • Software Vendor audits
  • CRO/CMO CSV audits
  • CSV and 21 CFR Part 11 training

IT

  • Lifecycle Development for custom software Project Management
  • IT Project support

Other Compliance Services

Compliance/Quality Assurance

  • GLP/GCP/GMP/QSR compliance program development
  • GLP/GCP/GMP/QSR process and documentation audits (internal and contract organizations)
  • SOP development
  • Training
  • QA Assistance

Regulatory

  • 483 assessment, response, and remediation support
  • Warning Letter assessment, response, and remediation support
  • Submission development and reviews

LAB

  • Process Review GLP, CLA
  • Compliance for Licensing (state of NY, RI, FL, etc.) 
Compliance for Licensing with CAP

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