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Assurance (Validation) Strategy and Services

The life sciences industry lives and breathes in innovation – nearly every company is looking for the next big thing. But all the breakthrough drug discoveries and technological leaps forward mean little without an assurance (validation) strategy that guarantees a replicable level of quality and efficacy.

Some say it’s a necessary evil, we say it’s untapped potential.

It’s not that assurance (formerly referred to as validation) itself is difficult. Given the time and resources, most companies could execute a suitable assurance 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 assurance process to meet global needs without being overly cumbersome.

A comprehensive assurance strategy incorporates your current state with your future aspirations so that validation is never the roadblock to your larger organizational goals.

  • Assurance (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 an environment that works for you, not against you.

  • System Implementation/Project Management
  • Prospective/Retrospective Validation
  • Testing Automation

What Our Clients Say


Pharmaceutical Company

Rather than doing the project for us or to us, Clarkston truly worked with us as part of the team to the conclusion of a successful project.

We helped a recently commercialized biotech establish assurance (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 assurance expert, Irene Birbeck.

Contact Irene

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