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TAG has the resources and experience to assist your organization to remediate its quality and compliance gaps so that you can achieve your quality goals more quickly and efficiently.

Often an unplanned part of achieving compliance goals, mitigating or eliminating audit and assessment findings can take time and resources beyond what was originally intended. Our proven ability to design and implement scalable, cost-conscious and creative solutions uniquely qualify us to resolve audit findings quickly and efficiently.

Compliance & Implementation Assistance

TAG provides professional consulting and expert implementation assistance to help clients remediate any Title 21 CFR GMP Regulatory issues:

  Good Manufacturing Practice Process Development
  Project Management Services
  Gantt and Timeline Development
  Template Implementation
  SOP Development
  Development Part 11 Initiatives

  Quality Systems Initiatives
  Validation plan development
  Education and training
  Documentation development
  Vendor audits
  Security reviews
  SOP development
  Test plan development and execution
  Quality assurance
  Development methodology review/evaluation
  Validation 'gap' analyses
  Validation Consulting Services
  Clinical Data Management Services
  Monitoring Services
  Quality Assurance Services
  Information Technology Consulting Services
  Contract Programming and Software Development Services
  Document Management Consulting Services
  Needs Assessment Services
  Metrics and Best Practices Services
  Training and Documentation Services
  21 CFR Part 11 - Quality Systems Initiatives. Remediation & Auditing
  Computer Systems and Software Validation Auditing
  Clinical Data Management Software
  Electronic Data Capturing (EDC) Systems
  Supplier / Vendor Compliance Audits
  FDA Preparations, Resolutions and 'For Cause'.
  GVP - Good Validation Practices Training
  Equipment / Process Validation - Ethical, OTC, R&D and Manufacturing
  Validation / Verification / IQOQ Gap Analysis & Risk Assessments
  Facility & Process Start-ups, Scale-ups & Commissioning
 

Not sure if your company can pass a GMP, GLP, GCP, Quality Systems, - Part 11 & QSR Part 820 audit?
 

Get an independent assessment of your quality and regulatory readiness today!  Or call 856-596-2333


 

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