Compliance Assessments,
CAREERS |
Our Compliance Group was founded to provide regulatory and technical expertise to support US and European Regulatory Areas. With our extensive experience, our teams can support all your compliance initiatives and requirements. The following includes our approach and types of Audits and Assessments Performed.
1. Types of Assessments/ Audits
Mock Pre-Approval Inspection
- by Ex- FDA Investigators & Industry Experts External Supplier Audits (World Wide)
Quality Assurance Programs
- Review of Change Control / Configuration Management Programs - Document Control Systems - Batch Record Review Compliance Assessments may include:
- Evaluation of Quality Systems, Corporate Policies, SOPs - cGXP Compliance Evaluation - Review of Validation Studies, and Documentation - Resolution of Compliance and Quality Problems - Compliance Review of Facilities and Equipment - Computer Systems Validation vs. US and European Requirements - Analytical Laboratories Audit 2. Consent Decree / Warning Letters / 483 Remediation Activities
Our teams can support all your needs related to responding to Warning Letters, 483s, and
Implementation of Corrective Action Programs, and other Remediation
3. Assessment Approach
Our assessments and audits follow a defined path:
a. A regulatory reference list defining the agencies and applicable laws, regulations, and
industry practices from the latest publications your system or area will be assessed against. b. Through a detailed review of your systems and documentation, our reviewers assess
the quality of your operation. c. The assessment will define the gaps or non-compliance issues and rate the finding
against a point numbering system. Audits & Remediation
Services
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