Audit Service


	GXP AUDIT SERVICE QCP GXP Auditing Services (3.70 MB) Periodic internal and external audits diminish overall risks connected with operating your company by identifying potential issues, by implementing contingency plans and by managing solutions before they become problems. Whether for Manufacturing, Laboratories, CMO’s, Inspection Readiness, or other services, we can provide audit services on a global basis. Quality Compliance Partners' auditors have the experience and qualifications to assess the tools, techniques and controls in place for GXP compliance. Specifically, our Lead Auditors and Technical Specialists have extensive experience in GMP, GCP, GLP, QSR and Part 11/Systems Audits. Part of a robust Quality System is an Audit Program. Periodic internal and external audits ensure compliance and diminish overall risks connected with operating your company and working with vendors by identifying potential issues, implementing contingency plans and managing solutions before they become problems. QCP, Inc. can: Ø Set up or enhance your Internal and/or External Auditing Program Ø Conduct Vendor/Supplier Qualification Audits Ø Conduct On-going periodic Vendor/Supplier Audits Ø Conduct Internal Audits/Assessments QCP, Inc.’s audit services include: Ø Quality System Auditing Ø Equipment and Facility Auditing Ø IT Quality System Audits Ø Software Quality Audits Ø GMP Audits Ø GCP Audits (CRO & Clinical Site Audits) Ø Laboratory System and GLP Audits Ø Contract Vendor & Supplier Audits Contract Manufacturers API/Excipient/Component Suppliers Contract Testing Laboratories Secondary Packaging Our Audit Approach ü Identify Areas and /or Systems to be audited and purpose of audit ü Determine the scope of the audit ü Request governing Standard Operating Procedures ü Identify the governing regulations / compliance standards ü Prepare and disseminate audit checklist (based on above items) ü Meet with department or function to agree on audit expectations and schedule the audit ü Perform audit of relevant activities against established procedures, and regulations, and regulatory guidelines ü Debrief the auditees on findings and recommendations ü Prepare audit report draft and circulate for review ü Meet with principals to agree on final report guidelines ü Prepare final audit report incorporating appropriate and necessary revisions ü Issue final audit report Benefits of Using QCP for Audits: v Provides an External Viewpoint, familiar with industry practices v Allows internal personnel to focus on other priorities and duties, without time out of their schedule for travel v Provides specific expertise you may not have within your internal audit team

Quality Compliance Partners, Inc.
Office: 858-605-1744
info@qualpartners.com
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