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 >>
The Orange Report Offers a Unique Community Experience
By leveraging our licensed audit results, Subscribers receive:
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Audit report
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Audit findings response
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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 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
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Quality Management System and Personnel and Training
BONUS: Capabilities and Qualification Questionnaire
Includes Supplier information within Enhanced
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BONUS: Audit Report, Responses and Certificate
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