>> VALIDATION SOLUTIONS

At the heart of our services is our thorough understanding of compliance.   At Compliance Associates, we have an in-depth understanding of international regulations and assist our clients in staying up to date and responding to the latest developments in regulatory compliance.  

We attribute our success to our ability to provide innovative, quality and cost-effective compliance solutions.  We are recognized within the life science community for streamlining the validation process by designing a variety of tools, techniques and methods to efficiently achieve the desired outcome.  Our well-defined structured methodology and approach follows best industry practices and complies with all international agency requirements.  Our validation services include:

 • Validation Project Management Services
 • Validation System Policies
 • Gathering User Requirements
 • Evaluation and/or Development of SOPs
 • System Validation Strategy
 • Risk Assessments
 • Creation of Validation (Master) Plan/Protocols
 • Creation of Test Plans
 • Methodology Development
 • Vendor and CRO Audits
 • Design, Network, Installation, Operational, and Performance Qualification
 • Development and Execution of Test Scripts and Automated Test Scripts
 • Incident/Deviation Reporting
 • Short-term and Long-term remediation strategies (Gap Analysis)
 • Development Validation Summary Reports
 • Support & Maintenance Planning
 • System (De)Commissioning
 • Training Services