Quality, Validation, Regulatory, Clinical Do you have the experts you need?
Validation Associates has successfully provided validation & staffing services to leading global corporations in regulated businesses such as Pharmaceuticals, Biotech and Medical Devices. Based on deep expertise acquired over many years and rich experience gained in a variety of validation projects, Validation Associates offers efficient validation services that include development of validation strategies and plans, creation and execution of IQ/OQ/PQ scripts, documentation of test results, design of traceability matrices, and delivery of a comprehensive summary report. Our success in validation services has been driven by our knowledge of regulatory issues related to software and IT systems. Our solutions ship with tools, scripts, and templates that enable us to effectively manage validation projects to ensure that your IT operations, policies and procedures, and quality systems are in compliance with the necessary rules and regulations.
Validation Associates delivers consultants to clients who need them for regulatory and compliance projects, right now.
Our Regulatory and Validation Compliance Consulting Practice provides services in quality systems and compliance for both project based needs or staffing of specialists to augment your team or fill niche subject matter expertise.
Due to the criticality of balancing regulatory needs, implementing effective practices, ensuring quality throughout the life cycle, validation for systems, and GMP/QSR compliance, organizations are taking a more comprehensive view of compliance and Validation Associate can help. In addition, the enhanced pressure by regulatory agencies surrounding system compliance with regulations such as 21 CFR Part 11 and GCP's increase the need for organizations to ensure validation. Non-compliance and the reinvigoration of oversight programs by the FDA and NIH could result in delays costing sponsor companies millions of dollars or could even result in the suspension of trials.
Validation Associate's team has extensive experience in building teams for on-site and off-site assignments designed to lead and support compliance and validation initiatives. Whether we are assisting a client by helping them augment their existing team through staffing services or building a highly qualified team to support an outsourcing effort, our focus is on bringing the right level of talent to bear on your projects.
The highly experienced consultants of Validation Associates Professional Services Organization provide the technical expertise and project management capabilities needed for successful implementation of the Validation Associates solution. The proven Validation Associates Implementation Methodology (VAIM) ensures successful project execution by employing industry best practices. It reduces implementation time, minimizes risk, and ensures that our solutions are configured to meet your needs
Validation Associates solution managers work closely with the client business and technical project leads to define an implementation plan and schedule, including resource requirements from the customer, and change management processes. All risks are identified upfront, and appropriate mitigation plans are documented.
The Validation Associates solution manager takes the project through the following implementation stages which are overseen by the account manager and the executive sponsor of the project:
- Project Planning
- Requirements Definition
- Solution Design
- Solution Configuration and Development
- Quality Assurance and Validation
Implementations vary in scope, complexity, and duration depending on the exact customer requirements. Validation Associates ensures long-term success by analyzing and fulfilling clients 'current needs while providing the scope for growth to support clients 'future compliance initiatives.