Computer Software
Assurance: Your Key
to CSV Modernization
The FDA highly 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 puts critical thinking at the core of 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
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 opportunity. 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.
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
CLICK BROCHURE BELOW FOR FULL BENEFITS LIST
BROCHURE
CSA: CSV Modernization Overview
Understand the definition, benefits, journey, and vision for a successful validation modernization - including our Computer Software Assurance approach.
CASE STUDY
Increasing Speed to Market & Reducing Cost with CSA
See how Trissential's CSV modernization approach is saving cosmetics client around 20% on cost and cycle time.
"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