CSA / CSV
Revolutionize Your Validation With CSA
40+
Clients shifted from
CSV to CSA
500+
Systems “assured”
using CSA
20K
Pages of
documentation reduced
10K+
System defects
found
80%
Average reduction rate in test script errors
YOUR CSA JOURNEY STARTS WITH CG
The CSA journey provides a clear and disciplined path from awareness to meaningful application, strengthening understanding and aligning teams with modern quality and technology practices. By progressing through these steps, organizations build the capability to apply CSA with consistency and establish a structured foundation for scaling it across critical systems.
FDA Industry CSA (FICSA) Team
AWS HC & LIFE SCIENCES
Senthil Gurumoorthi
BECTON DICKINSON
Roy Devine
Frank Meledandri Sr.
BOSTON SCIENTIFIC
Damien McPhillips
Ray Murphy
EDWARDS LIFE SCIENCES
Andy Lee
FDA
Daniel Walters
Fresenius Medical Care
Marc Koetter
GILEAD
Ken Shitatmoto
GSK
Louie Rayal
Stephen Cook
GETINGE
Francisco Vicenty
INSULET
Lou Poirier
JOHNSON AND JOHNSON
Reggie George
MDIC
Joseph Sapeiente
MEDTRONIC
Anake Kiatdilokrath
Joanne Goldberg
MICROSOFT
Frankie Bill
FICSA ADVISORY
Paul Sumner
PHILLIPS
Pat Baird
ROCHE
Thorsten Ruehl
SIEMENDS DIGITAL INDUSTRIES
Robin Blankenbaker
TAIHO ONCOLOGY INC.
Margie Hindley
PAST TEAM MEMBERS
Laura Clayton
Bill Hargrave
Joe Hens
Scott Moeller
Ron Schardong
John Murray (FDA)
Penny Sangkhavichith
Dana Guarnaccia
Michael Branch
Des Chesterfield
Stacey Allen
Sean Benedik
Bill D'Innocenzo
Curt Curtis
Jason Spiegler
Mike Wilt
Tina Koepke
April Francis
Jason Aurich
Prakash Patwardhan
BENEFITS TO THE CSA FINAL GUIDANCE
Reducing the documentation burden, and prioritizing paitent safety and product quality
Smarter, Risk-Based Assurance
More efficient use of resources while still protecting quality and compliance.
Enabling Innovation and Agility
Faster adoption of new technologies like automation, AI/ML tools, and cloud platforms without being slowed down by outdated validation expectations.
Reducing Compliance Burden
Significant time and cost savings while maintaining FDA compliance.
Strengthen Quality and Patient Safety
Better alignment of regulatory expectations with product safety and performance outcomes
Supporting Digital Transformation
Provides regulatory clarity that encourages manufacturers to modernize operations and adopt digital technologies with confidence.
VALIDATION EXPERTISE ACROSS SYSTEMS
Whether you’re validating legacy software, modern SaaS platforms, or AI-powered applications, we’ve done it.
WE SUPPORT VENDOR SOFTWARE:
Quality and Lifecycle Management
We support systems that ensure compliance and governance across the product lifecycle, including QMS (Veeva, Trackwise), ALM (Polarion), PLM (Siemens, Dassault), and LMS (Cornerstone, ComplianceWire).
Manufacturing and Enterprise Systems
We validate core platforms for production and operations, including ERP (SAP, Oracle), MES (Siemens, Critical), labeling (Bartender, Nicelabel), serialization (Tracelink, Covectra), CRM (Salesforce), and automation (Siemens, Rockwell).
Laboratory Systems
We bring expertise in LIMS (Labware, Starlims), lab interfaces, and analytics (Power BI, R Studio, SAS). Our teams also validate Excel and other desktop or web-based tools in regulated environments.
Digital and Low Code
We validate low-code and digital platforms such as Mendix, Microsoft, and Appian to ensure compliance, scalability, and flexibility for modern applications and custom solutions.
Featured Insight
Embracing Vulcan Logic: Critical Thinking in Software Assurance Transformation
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Embracing the Risk-Based CSA Approach with Paperless Validation
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From CSV to CSA: Simplifying Veeva Validation for Seamless Platform Adoption
