THE BUSINESS CHALLENGE
Some say it’s a necessary evil, we say it’s untapped potential.
It’s not that validation itself is difficult. Given the time and resources, most companies could execute a suitable validation process. But it’s just that – it requires time and resources, two things that most companies don’t just have lying around.
Clarkston’s risk-based approach creates an efficient and compliant validation process to meet global needs without being overly cumbersome.
A comprehensive validation strategy incorporates your current state with your future aspirations so that validation is never the roadblock to your larger organizational goals.
- Validation Master Plan
- Short and Long Term Road Mapping
While there are technologies that enable validation, it’s the people and processes that will ultimately determine the success of your validation initiatives.
- Organizational Support Capabilities
- Change Management and Training
- Local/Global Processes and Procedures
Coupling strong cultural and organizational elements with harmonized systems of data and technology creates a validation environment that works for you, not against you.
- System Implementation/Project Management
- Prospective/Retrospective Validation
- Testing Automation
What Our Stewards Say
Validation strategy isn’t something modern life sciences companies can afford to ignore. A proactive, easily maintained and upgraded validation program will benefit your bottom line more than you know.
We helped a recently commercialized biotech establish validation and system development life cycle strategies for technology implementation as they prepared to launch new products. For more information on how we can help your company, please contact our validation expert, Irene Lewis.