Areas of Practice
Validation
Validation Quality Policy
User Requirement Specification (URS)
Functional Specifications (FS)
Validation Master Plan (VMP)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Test Method Validation (TMV) Computer Software Validation (CSV)
Non-Conformance Reports
Identification
Initiation
Investigation
Disposition
Closures
Addendum
Audits
Consent Decree
Good Manufacturing Practices
FDA Audit / Remediation
Quality Management System
Corrective Action & Preventive Action
Define
Measure
Analyze
Implement
Control
Facility Qualifications
Facility Project Relocation
Expansion
Facility (new/existing)
Commissioning
Project Management
Initiation
Planning
Execution
Control
Closure