quote

CG surprised us with better than expected improvements. These guys are experts and they’re great to work with.

Head of IT, Medical Device Manufacturer

compliance-services

40%

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Overall Efficiency
Increase

45%

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Reduction in Val/Test Planning Time

40%

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Reduction on Val Execution Time

60%

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Reduction on Summary Reporting Time


CG SOLUTION PORTFOLIO FOR ACTIVATING FRICTIONLESS QUALITY

“CG’s experts remediated 60+ systems in less than a year and streamlined our procedures to align with the latest and ever-changing regulations” - Head of IT Quality

EXPERTISE

  CSA/CSV
  Commissioning, Qualification, Validation
  QA, MFG Automation Validation
  QMS Admin Support
  Audit (Supplier/Internal)
  Clinical Process & Solutions
  IT Support

PROCESS

  Data Integrity
  SaMD
  Process Validation
  Inspection Readiness
  Quality Management System
   Organizational Change Management
  Problem Solving Leadership Development

TECHNOLOGY

  Digital CSA/CSV
  Design Control and Risk Management
  Equipment Qualification
  Process Validation / pFMEA
  Extended Low-Code Apps
  Siemens Polarion
  Mendix

LEADING THE WAY IN QUALITY BEST PRACTICES AND DRIVING REGULATORY CHANGE

CG helps life sciences companies make quality frictionless, while reimagining regulatory compliance. As industry thought leaders, we deliver the exact expertise, process and technology required for our customers to achieve sustained quality excellence across the value chain. Our customers are able to deliver higher quality products to market faster and at lower cost, improving patient health and meeting regulatory requirements as a natural outcome.

early-adoption

CG’s membership in the FDA Case for Quality CSV Team enabled trust and allowed for early adoption of new guidance.”

Kurt Weber, Director of IT, Vericel

fda-csa-logo

FDA –Industry CSA “FICSA” Team Founding Member

mdic

Medical Device Innovation Consortium
Contributor to FDA Case for Quality and the Advanced Manufacturing Clearing House (AMCH)

ispe-gamp

ISPE GAMP Americas Steering Committee
CG is the Co-Author of ISPE GPG

  • Data Integrity by Design -2020
  • Enabling Innovation – 2021
  • GAMP 5 - 2nd EDITION July 2022