The FDA recommends life science organizations start modernizing their Computer System Validation (CSV) to mitigate manufacturing risks that are impacting product quality. This new ‘shift-left’ approach, known as Computer Software Assurance, puts critical thinking at the core of the CSV process versus a ‘test-everything’ method, which reduces risk and provides worry-free FDA audits.

It’s time to take your regulated validation environment into the future with an end-to-end custom playbook based on the FDA’s latest guidance. You need Computer Software Assurance (CSA). Our CSA and Quality experts take you through the what, why, and how in our 30-minute podcast.

Start – Robert & Scott: CSA history, internal and organizational benefits, implementation approach, transition journey, and what changes

18:44 – Robert & Jon: Common client questions and concerns including – How CSA boosts a risk-based approach, financial benefits, FDA audit improvements


COST SAVINGS OF A CSV MODERNIZATION
  • Adopting standardized practices: 15-20%
  • Focusing on Risk Management (GAMP): 15-20%
  • Centralized resources and approach: 15%
  • Technology adoption: 10%

Total transformational cost savings: 55-65%*

*From International Society for Pharmaceutical Engineering – GAMP

ADDITIONAL BENEFITS
  • Increased speed to market
  • Consistent communication and awareness
  • Clarity of roles and responsibilities
  • Enterprise-wide reporting and transparency

READ THE FULL CSA OVERVIEW HERE


TRUST THE EXPERTS

Let’s see where you’re at with validation modernization

Trissential is committed to helping organizations implement and operate a centralized validation function to support the efficient and effective delivery of safe products to market while optimizing business opportunities. Our validation experts support regulatory compliance goals with technology and a focus on risk-based validation and critical thinking.

We meet each client where they are – our ‘one size fits one‘ approach is tailored to each organization. We understand your current state in your validation modernization journey, assess gaps and areas for process improvements, and define areas of interest where you can make an immediate impact.

“Trissential has been an integral part of the Data Integrity Program’s success. Our Partnership began in 2016 with the rollout of our Computer System Validation process which has now transitioned to Computer Software Assurance. Trissential’s knowledge of the compliance industry along with highly skilled resources have been key to many of our project deployments.”

– Executive Technical Director of IT Compliance