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.

 

LISTEN TO 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

HubSpot Video
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

CSV Modernization Journey
BROCHURE
CSA: CSV Modernization Overview

Understand the definition, benefits, journey, and vision for a successful validation modernization - including our Computer Software Assurance approach.

BROCHURE
CSA Brochure
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.

CASE STUDY
Cosmetics CSA Competency Center Case Study-2
"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