Set an assurance strategy that focuses on product quality and patient safety.
Setting an assurance strategy that focuses on how the computer system impacts the product quality and patient safety, and then using a risk-based approach to determine the level of validation required is important. It requires the time, expertise, resources, and that is where we help.
Clarkston’s risk-based approach creates an efficient and compliant assurance process to meet global needs without being overly cumbersome.
A comprehensive computer software assurance strategy incorporates your current state with your future aspirations so that validation is never the roadblock to your larger organizational goals.
- Computer Software Assurance (CSA) Strategy
- Computer Software Assurance (Validation) Master Plan
- Transition from CSA from Validation
While there are technologies that enable validation, it’s the people and processes that will ultimately determine the success of your validation initiatives.
Coupling strong cultural and organizational elements with harmonized systems of data and technology creates an environment that works for you, not against you.
- Local/Global Processes and Procedures (SOPs)
- Prospective/Retrospective Validation
- CSA Managed Services
What Our Clients Say
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.