THE BUSINESS CHALLENGE
The regulatory environment is tightening and navigating compliance issues has grown more complex.
Consumer focus on wellness has pressured CPG companies to develop and market health-related products. The FDA will be placing greater scrutiny on products that are being developed to meet the needs of the health-conscious consumer. This new regulatory oversight places significant focus on validation so investing in a sound process now will pay dividends in the future for your compliance position.
Clarkston’s risk-based approach creates an efficient and compliant validation process to meet global needs without being overly cumbersome.
Developing a complete validation strategy with short- and long-term objectives is crucial to upholding a continuous validated state.
- Validation Master Plan
- Short and Long Term Road Mapping
Clearly defined organizational alignment, processes, and procedures support a long-term validation process and ensure ongoing compliance.
- Organizational Support Capabilities
- Change Management and Training
- Local/Global Processes and Procedures
Building the infrastructure to support continuous validation enables operational efficiencies and cost savings.
- System Implementation/Project Management
- Prospective/Retrospective Validation
- Testing Automation
What Our Stewards Say
Validation brings a whole new set of challenges and opportunities for the consumer products industry. But validation is really just the first step, it’s crucial for organizations to take a proactive approach to best prepare themselves for what’s next on the regulatory horizon.
We worked with a global health and beauty manufacturer to develop and actualize a validation strategy for their research and development computer systems. The project resulted in a fully compliant position, increased capabilities in responding to regulatory requests, and an improved validation culture. For more information on how we can help your company, please contact our validation expert, David Patterson.