Providing our clients with risk-based agile approaches
We focus on providing our clients with risk-based agile approaches to best balance regulatory compliance with business objectives. Our team continues to earn its reputation for customer satisfaction through years of forward thinking thought leadership in computer system validation.
We provide end-to-end, integrated solutions and support
Strategic Assessments
Digital Validation
business strategy
Digital Validation
CSV to CSA Process Transformation
Agile Risk-Based SDLC Adoption
Managed Services
Managed Services
Quality and Change Management
Strategic Advisory
Our Mission
Agile Driven
We focus on providing our clients with risk-based agile approaches to best balance regulatory compliance with their business objectives.
Team Focused
We work to build partnerships that understand clients’ regulated software requirements and build the best collaboration between clients and software vendors.
Expert Support
Key Subject Matter Experts in Computer Systems Validation (CSV) and Computer Software Assurance (CSA) ensure expert assistance when needed.
We believe high-quality work and a high-quality lifestyle are not
mutually exclusive
As a trusted strategic advisor for regulated software quality testing within the Life Sciences industry, ProcellaRX examines your business process symptoms, defines your diagnoses, and provides targeted prescriptions to improve your quality outcomes.
Rethink
Sometimes all you need is a new perspective. Our teams deconstruct your day-to-day software quality business and regulatory processes to identify digital validation optimization and transformation solutions.
Reshape
Solutions should be shaped to fit an organization’s’ people, processes, tools and culture. Together we’ll modernize your policies and platforms to accelerate your software quality and compliance objectives.
Remake
Organizational change management (OCM) is critical to your digital transformation journey. Our teams facilitate enablement and adoption that promotes sustained growth while beginning where you are today.
Learn more about us and our services
Stay Tuned for Upcoming Events
KENX Conference
Learn more abour KENX Conferences and take advantage of their valuable free process documents
Computer Systems Validation & Software Assurance University
- December 6-8 2022
- Hybrid Event - Philadelphia
Kenx Validation & GMP University
- November 21-23 2022
- Hybrid Event - Dublin
PRX & Sware Quality Leadership Roundtable
- November 18 2022
- Princeton
PRX & Sware Quality Leadership Roundtable
- November 17 2022
- Raleigh
PRX & Sware Quality Leadership Roundtable
- November 16 2022
- Chicago
Michigan Women's Leadership Network - Annual Event Defy Boundaries
- Thursday, November 3 2022, 5 PM EST
- Detroit
Women in CSV Coffee Break (every 3 weeks) | Guest Tanya Sharma
- Thursday, November 3 2022, 4PM EST
- Virtual
Women in CSV Coffee Break (every 3 weeks) | Guest Melissa Hohauser
- Thursday, October 13 2022, 4 PM EST
- Virtual
Women Leading Validation Webinar: Actionable Communication with Debra Roberts
- October 6 2022, 4 PM EST
- Virtual
PRX CSA Feedback Forum
- September 30 2022
- Virtual
Breaking Away from the Status Quo: Evolving Mindsets and Behaviors to Move Our Industry Forward
- September 28, 2022
- Boston
GMP University
- August 22-24, 2022
- San Diego
Biopharmaceutical University
- June 6-8, 2022
- San Diego