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Auditing and Validation Services for FDA Regulated Industry

FDA - WHO - EMeA - DEA - GMP - GLP - GCP - Part 11 - Validation - GXP Training - Remediation

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Validation Audits - Training - Development

Good Validation Practice Auditing Services

Our experienced auditors perform all types of Process, Equipment, Facility, Software, hardware and systems validation audits, including departmental audits, vendor audits and other project-related audits pertaining to electronic systems. Audits assess compliance with SOPs and Good Clinical Practice, appropriate government regulations/guidelines and ICH standards.

Audit, Develop, Execute, Coordinate & Direct:

  • Validation Master Plans
  • Project Plans - Detailed plans
  • User Requirements
  • Functional Requirements (with appropriate matrices to test cases)
  • cGMP, GLP, ISO or ICH Summary Statements
  • Design Qualification Protocol Development
  • Design Qualification Component Check Lists & Acceptance Criteria
  • Installation Qualification Protocol Development
  • Engineering Review, Qualification or Verification - Drawings / Schematics / Flow Diagrams
  • Documentation Review - SOPs / Validation Protocols / Technical Manuals / Process Standards
  • Auditing - GMP, GLP, GCP, ICH and ISO Standards Qualification / Verification
  • Installation Qualification Component Inventories
  • Installation Qualification Test Criteria & Summary Reports
  • Operational Qualification Protocol Development
  • Risk Assessments & Analysis - 21 CFR Part 11 Assessments
  • Test Case Authoring & Review
  • Vendor Audit Summaries
  • Execution of Test Cases
  • Functional/User Requirements
  • Operation Qualification Anomaly Analysis & Summary Reports
  • Installation Qualifications Protocols
  • Performance Qualification Protocols
  • Performance Qualification Test Cases & Acceptance Criteria
  • Validation Summary Report
  • Validation Life Cycle Summary Report
  • Validation Acceptance - Equipment / Process / Computer Systems / Application Commissioning

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GMP, GCP, GLP, QS and Part 11 / Systems Audit

21 CFR Part(s) 11, 210/211, 820, ICH Q7

Food and Supplement GMP Audits

Mock FDA - EMEA Audits

Pre-Site Inspections - 'For-Cause'

Quality Assurance Audits

Quality System Audits - Part 820

SOPs, Quality Assurance and Standards Audits

GMP - Good Manufacturing Practice Audit

GCP - Clinical Audits - Regulatory Audits

Equipment Validation Documentation Audit

Software / Systems Validation Audits

Part 11 / Annex 11 Compliance

Vendor & Supplier Audits -

CMOs, Laboratories, API Manufacturers

CROs, Investigators, Monitors, and Study Sites

Database Audits, SAS, CMMS, eDC, eCFR, Safety

Project Management Services
Gantt and Timeline Development
Template Implementation
SOP Development
Development Part 11 Initiatives


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