Regulated Industry Services:

Validation Services

Allegiant provides FDA-regulated industries such as the Pharmaceutical, Biotechnology, and Medical Device, with validation services which will satisfy the stringent demands of current Good Manufacturing Practice (cGMP) Regulations and Quality Systems Regulations (QSR). We can support your efforts allowing you to complete your project on-time and on-budget, while assuring compliance with the current industry regulations and standards.

Our personnel and services can support your need to plan, prepare, document, and executein accordance with cGMP. Common services include equipment, facility, and utility systems validation:

o Compliance Assessments
o Validation Master Plan Development
o Validation Project Management
o Development of Quality System documentation (Plans, SOPs, Protocols, Schedules, Reports)
o Factory Acceptance Testing (FAT)
o Site Acceptance Testing (SAT)
o Installation Qualification (IQ)
o Operational Qualification (OQ)
o Performance Qualification (PQ)
o GAP Analysis and Remediation
o Risk Analysis
o Identify potential failure scenarios
o Estimate the likelihood of these failures
o Evaluate the severity of each potential risks
o Development of Risk Based Impact Assessment
o Validation Program Auditing and Optimization
o Policy and Procedure Development
o Validation Master Plan Preparation
o Project Management
o Protocol Preparation (IQ,OQ, PQ)
o Test Execution (IQ, OQ, PQ)
o Deviation Resolution - Corrective and Preventive Action (CAPA)

If you would like to learn more about innovative services that are helping to bring new levels of efficiency to companies just like yours around the world, please contact us