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The Orange Report

20 Mar 2020 : The OR now has over 300 life science suppliers included.

Life Science Company Launches New Quality Supplier Website

(Cedar Park, Texas) June 18, 2019 – FDA Quality and Regulatory Consultants and its sister company, Solar Compliance have announced a unique tool to help in the due diligence and qualification of outsourced partners, The Orange Report. Subscribers to The Orange Report can search for pharmaceutical, biotech and medical device Suppliers across clinical, pre-clinical and manufacturing services. Read More >>

Our customers can search for pharmaceutical, biotech and medical device suppliers across pre-clinical, clinical and manufacturing services.





The Orange Report Offers a Unique Community Experience

By leveraging our licensed audit results, Subscribers receive:

  • Audit report

  • Audit findings response

  • Audit closure letter

Industry-leading experience in GxP Auditing

We have contractual relationships with hundreds of global suppliers. These relationships, developed throughout the last 10 years, provide both audit scheduling efficiencies and a high level of confidence.

On-site audit method includes:

  • Use of comprehensive agenda to evaluate regulatory compliance to GxP requirements
  • Interviews with staff and review of quality management system documentation, such as SOPs, policies and quality plans
  • Evaluation of multiple e-systems and functional areas

Audit report with findings

  • Provides summary of audit method, documents reviewed, executed/in progress changes and future planned changes, and listing of audit findings
  • Rates audit findings as minor, major or critical
  • Includes recommendations for improvement
Audit closure
  • Audit responses and timelines
  • Send closure letter

Download Supplier Analysis Reports

All your Due Diligence data to make a DECISION

Includes Supplier information regarding Culture, Regulatory Experience and Quality Indicators

Includes Supplier information within Basic
Quality Management System and Personnel and Training

BONUS: Capabilities and Qualification Questionnaire

Includes Supplier information within Enhanced
BONUS: Audit Report, Responses and Certificate


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