cGxP

Consulting

 

HomeAbout UsExpertiseServicesNewsGuidancesLinksPresentationsTrainingSearchContact UsEmploymentContents

 
 
Laboratory
 
cGxP specializes in Analytical Method Validation and in providing cost-effective DQ, IQ, OQ and PQ services for new and existing laboratory equipment. We have the knowledge and experience to validate your methods, specifications, and total computerized laboratory system; hardware, software and instruments.  Our validation team will evaluate your new (proposed vendors) or existing instrument or system and create all documentation required to meet and maintain cGMP compliance.  

medical devise

medical devise

medical devise

laboratory

healthcare

  • Analytical Laboratory Methods (Test Method Validation) from Pre-Clinical, Clinical, Chemistry, Biology, Microbiology, Stability, Physiology, Software V&V, Packaging & Labeling, Engineering, Field Trials
  • Test Method: Characterization, Validation, Equivalency, Transfer, Suitability for Use, Methods In Support of Manufacturing Cleaning or General Study. (Protocols and Reports)
  • Lab Instrument and Equipment (DQ, IQ, OQ, PQ) 
  • Analytical Instrumentation
  • Chromatography Data Systems
  • LIMS
  • Environmental/Stability Chambers
  • Custom Interfaces
  • cGMP Compliant Documentation
  • SOPs
  • Calibration
  • Preventive Maintenance
  • Training Materials
  • Lifecycle Approach
  • Audits and Compliance Assessments
  • Validation Master Plan
  • Validation Manual Development
  • Technical Writing
  • Operator and System Certification
  • Documentation Control
  • Validation Assessment
  • In vitro Diagnostics process and test method validation

 

 

 

 

 

HomeAbout UsExpertiseServicesNewsGuidancesLinksPresentationsTrainingSearchContact UsEmploymentContents

 
 
Hit Counter