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Norton Audits Completes 5 Year Sepsis Study Auditing Contract
09.10.2017
18 Audits Conducted from 2011 through 2017
(More)
Norton Audits Completes Investigator Systems Consulting
05.22.2017
Focus in Quality and Marketing Leads to New Business Model
(More)

Independent GCP Auditing:

Proactive Risk and Compliance Audits of Your Protocols, Procedures and Activities


Similar to our clients, our Auditing Goal is to Protect Human Subjects while achieving Clinical Trial Product Safety and Efficacy Objectives. We accomplish this through Quality Systems-Based Audits (not just simple checklists) that focus on proactively identifying the risks and non-compliance that compromise patient safety and product efficacy. Whether auditing against your Protocols or Standard Operating Procedures, Industry Standards or Regulatory Laws, NAI independently assesses your compliance level while also providing valuable recommendations for improvement.

Our Auditing Experience represents the three primary sides of Compliance:
  • The US Food and Drug Administration – Consumer Safety Officers
  • Major US Pharmaceutical Manufacturer – Senior Clinical Research Associates
  • Independent Auditors – Having completed 100s of Sponsor, CRO, IRB and Investigator GCP Audits

Our Auditing Techniques and Scope Include:

  • Data Trending
  • Anchoring
  • Informed Consent   
  • Training Records
  • Regulatory Documents
  • Case Report Forms
  • Facility Inspection
  • Record Storage
  • OSHA Requirements
  • Mock FDA Audits
  • Assessing Monitoring Effectiveness
  • Source Documentation
  • Adverse Event Reporting
  • Drug or Device Accountability
  • Protocol Violations and Waivers
  • Clinical Investigator Oversight
  • IRB, Sponsor and CRO Communication
  • Laboratory Data Collection Process
  • Financial Disclosure Requirements
  • Regulations and Standards Including


Our Auditing Deliverables Include:
  • Audit Plan            
  • Audit Certificate   
  • Close-Out Discussion

 

  • Color-Coded and Graded Compliance Findings Report
  • Recommendations for Improvement and Achieving Compliance
  • Overall Assessment Consistent with the FDA Definitions of No Action Indicated (NAI), Voluntary Action Indicated (VAI) and Official Action Indicated (OAI)

Our Auditor Proficiencies include;

  • Legal Expertise
  • Organizational Skills
  • Writing Skills
  • Interviewing Skills
  • Observation Skills
  • Communication Skills
  • Data Techniques


Our Auditing Metrics for 2012 - 2014 are as follows;

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For more information or to request an Audit, please contact us.


 
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