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Compliance Auditing |
| Early identification and effective resolution of the issues which are identified prior to FDA inspections can save development time and money. Polaris can perform independent audits of Sponsors, CROs, study sites, IRBs, non-clinical labs, manufacturing facilities, and data. Feedback from the audit can provide you with assurance that sites and facilities are in compliance with the regulations. |
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Polaris's auditing services include
assessments of:
- Vendor qualifications
- Investigators / Study Sites
- Sponsor/Contract Research Organizations
- Clinical Laboratories
- Institutional Review Boards
- Data integrity
- Internal consistency of reports and regulatory submissions
- Clinical Trial Materials
- Inspection readiness
- Quality Systems
- Equipment Validation (IQ/OQ/PQ)
- Cleaning Validation
- Water Systems Validation
- Process Validation
- Analytical and Microbiological Method Validation
- Computer Systems Validation
- Compliance with Part 11 regulations
- Due diligence of manufacturing operations and processing systems
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Polaris Audit Specialties:
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Polaris also works with clients to create or review non-clinical, clinical, and manufacturing, auditing plans, and can recommend revisions to those plans, if needed.
Polaris has provided GCP, GLP and CGMP services to the pharmaceutical, biotech, and nutritional industries located around the world, including: |
- Canada
- China
- Eastern Europe
- India
- Mexico
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- Russia
- South America
- Ukraine
- USA
- Western Europe
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200 Commonwealth Court, Suite 101 
