Validation Services

Control Associates has significant experience working with GxP and ICH guidelines. We understand the regulatory context and are driven by the desire to implement pragmatic approaches that meet compliance requirements. Our processes comply with all categories of GAMP® guidelines and are able to perform the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).  Ensuring accurate and reliable data is critical to maintaining loss/gain allowances and avoiding compliance and contractual issues, including risk-based methodologies.

• GAMP 5
• GAMP for MES
• ASTM E2500-07
• ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems and Equipment

• Budgetary Estimates
• Supplier Assessments and Audits
• Project Execution Strategic Planning
• Validation Master Plan Development
• Criticality, Data Integrity, and Risk Assessments
• Requirements Development

• Specification Development
• In-process Supplier Audits
• Code Review
• Standard Operating Procedures Development

• Commissioning, Qualification, Verification Protocol Development and Execution
• Traceability Matrices
• Project Reports