07/20/2012

Cambridge Biomedical to offer Quality Assurance Services

Cambridge Biomedical, a world-class diagnostic laboratory and specialized Contract Research Organization (CRO), has launched a new arm to its business to provide Quality Assurance support services to the pharmaceutical, biopharmaceutical, biotechnology, CRO, and medical device industries. Cambridge Biomedical takes great pride in their cutting edge scientific knowledge, diligent work ethic, flexible support provision, and excellence in operational support and is proud to offer Quality Assurance Auditing, Quality System Development, and Computer System Validation services. These services entail the following:

Quality Assurance Audits

  • GLP, GCP, GMP Vendor Qualification
  • GCP Clinical Site Audits
  • Due Diligence Audits
  • IN process/ critical phase audits
  • GLP, GCP, & NON-GLP Data & ReporT Audits
  • Inspection support
  • Quality System GAP Assessments
  • Mock REGULATORY INSPECTIONS

 QUALITY SYSTEM Development

  • Quality System Design/ documentation
  • SOPs
  • Forms
  • Templates
  • Vendor Questionnaires
  • Conversion from Paper system to electronic System

 Computer System Validation

  • Selection, validation, implementation
  • Software vendor Qualification
  • Business/ System Analysis
  • Document Development
  • Test Script Development/ Execution
  • Review/ Audit validation documentation
  • 21 CFR part 11 gap assessment

To inquire about any of these services please contact:

Manish Ranjitkar, Director of Quality Assurance Phone: 1-617-456-0744

Email: mranjitkar@cambridgebiomedical.com

Or send a general inquiry to the following email: QAinfo@cambridgebiomedical.com

  
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Providence RI 17-20th September

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Cambridge, MA 29 September

For existing clients & test results please contact 
Customer Service:617.456.0800
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