Need Computer System Validation?Overwhelmed by Compliance Challenges?
We've Got You Covered.
In the fast-evolving landscape of pharmaceuticals, staying compliant with international regulatory standards is not just crucial; it's a non-negotiable necessity. For those anticipating impending inspections or feeling lost in the maze of compliance requirements, our Computer System Validation (CSV) service is your strategic partner in navigating the intricate terrain of regulatory adherence.
The Audience Dilemma
Transforming compliance challenges into opportunities for excellence.
Impending inspections for local or international regulatory authorities:
Regulatory scrutiny can be daunting. Our CSV service ensures you are well-prepared, turning inspections into opportunities for validation excellence.
Not Knowing Where to Start or How Best to Comply with the Regulations:
We provide a roadmap tailored to your unique needs, ensuring a systematic approach to compliance that aligns with industry best practices.
Not Knowing How to Keep Up to Date with Current Best Practices:
Stay ahead with our team, well-versed in the latest industry standards and continuously evolving best practices.
Lacking Knowledge and Experience, Feeling Overwhelmed and Anxious:
Don't let the complexity of compliance overwhelm you. Our team of professional consultants and experts brings years of international experience to ease your journey.
Not Knowing Who Should Be Responsible for What:
Our approach clarifies roles and responsibilities, ensuring a streamlined and efficient validation process.
What We Bring
Team of Professional Consultants and Experts:
Benefit from the expertise of a dedicated team with years of international experience in validating various computerized systems across the pharmaceutical and biotech industry supply chain.
What You Will Achieve with
Our CSV Consultants
Driving compliance, confidence, and excellence in every step of your validation journey.
Comply with International Compliance Standards
Ensure adherence to international compliance standards, fostering a culture of excellence.
Align with Best Practices in GAMP 5 SE and Latest Guidance from CSA
Stay at the forefront of industry best practices with our alignment to GAMP 5 SE and CSA guidance.
Prepare for EU Inspections
Our experts help you navigate the nuances of EU inspections, ensuring a seamless process.
Perform Retrospective Validation
Enhance your validation process with retrospective validation strategies.
Efficiently and Effectively Validate Complex and Customized Systems
Tackle complex systems with confidence, leveraging our tailored validation approaches.
Our Approach and What Is Included
From Training to Templates: Everything You Need for Robust CSV Implementation.
“Factorytalk’s CSV expertise helped DHG confidently meet international audit and inspection requirements. With their support, we adopted the latest best practices and successfully prepared for EU GMP certification.
Factorytalk partnered closely with our management and project teams, enabling us to implement a practical and efficient CSV approach that ensured compliance without unnecessary complexity. We value their collaboration, whose commitment and professionalism contributed to the project’s success and strengthened DHG’s GMP knowledge and capability.”
Le Ha Ngoc Minh
Validation Supervisor, DHG Pharmaceutical Joint-Stock Company
“Factorytalk’s expert CSV training, aligned with GAMP 5 Second Edition and the latest regulatory trends, gave Schneider Electric’s global teams confidence in their compliance practices.
Their professional and insightful delivery made complex topics practical and easy to apply.”
Honghang Chen
Global Solution Architect – Life Science, Schneider Electric
“I challenged Factorytalk with co-creating an innovative risk-based CSV model for Tulip, a technology platform used globally across all sites, and to deliver it as apps managing data rather than using traditional documents.
Their mentality to partner with customers, creativity, and high quality services were instrumental in the projects success.”
Bob Buhlmann
Head of Quality Digital and Computer Strategy, AstraZeneca
Your Path to Compliance Confidence
We eagerly anticipate addressing your concerns and questions, providing not just answers but comprehensive guidance and direction. Our set of document templates will accelerate your future validation and compliance projects, leaving you with the knowledge, understanding, and confidence to elevate your organization's quality and GxP compliance to the next level.
Meet Our
CSV Consultants
Empowering your compliance Journey with expert guidance and proven tools.
Chompunut Apinan
Operations Manager
Douglas John Isles
Solution Quality Manager
How can we support you?
To make sure we give you the most relevant information about our products and services, please fill in the form, and we will be in touch quickly!
