Helping Companies Reach Compliance Goals Since 2005

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Software Implementation & Validation

equipmentTicalion provides topnotch software implementation and validation services to companies that need to meet requirements for FDA compliance and ISO registration and specialize in biopharmaceutical, biologic and medical device product development, manufacturing, and clinical trials.We understand that validation of the end unit is insufficient without validation of the entire supporting system and the development of strong quality-focused methodologies to maintain the validated state.Clients count on our team of experts to employ risk-based assessment to develop custom Master Validation Plans and Validation Protocols and employ GAMP 5 validation methodology to validate computerized environments including web-based, SaaS and cloud platforms.From large- to small-scale projects, our validation services include:

  • Data Center Validation
  • Computerized System Validation using GAMP 5 Methodology and FDA’s General Principals of Software Validation
  • Regulated IT Infrastructure and Computerized System Quality Strategies including 21 CFR 11 compliance
  • SDLC implementation
  • Computerized Medical Device Validation
  • ITIL IT Service Delivery Methodology Implementation including implementation of ISO 27000, ISO 20000, ISO 31000 standards
  • HPLC and Laboratory Equipment Validation
  • Change Management
  • Risk Assessment

Click here to request more information or call us at (410) 245-7237.

About Ticalion Quality Management Services
Ticalion provides expert quality system deployment and remediation services to meet requirements for FDA compliance and ISO registration.