Rethink. Reshape. Remake.

Software Quality Today

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​​Our Solutions

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.

Customer focused
Value oriented
Quality obsessed
People centric
​​Our Solutions

We provide end-to-end, integrated solutions and support

Strategic Assessments

Designed to rethink your day-to-day software quality and compliance objectives and benchmark against your industry peers and trends.

Strategic Assessments

Quick Checkup Assessment
Target Scope Evaluation
Deep Dive Review
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Digital Validation

Optimize digital validation solutions and tools using our targeted transformation roadmaps designed around your
business strategy

Digital Validation

Digital Validation Tools
CSV to CSA Process Transformation
Agile Risk-Based SDLC Adoption
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Managed Services

Support your team throughout your software validation lifecycle to respond to changes in the compliance, regulatory and operational landscape.

Managed Services

Application Managed Services
Quality and Change Management
Strategic Advisory
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​​Our partners

Meet our strategic partners

experience excellence

Our Mission

Life Science companies are accelerating their digital transformation journey. ProcellaRX is a consulting practice focused on digital validation strategies, testing tools implementation and enablement. We assist our clients with their digital transformation, providing end-to-end, integrated solutions and support.
about us
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.

Passion is what drives us

We believe high-quality work and a high-quality lifestyle are not
mutually exclusive

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about us
Our Philosophy

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. 

Testimonials
Curious about what people say about us & our services?
Life Science Expertise
Dori is genuinely in a league of her own regarding her depth of knowledge and experience in advising enterprise organizational transformations. Not only can she make recommendations that help organizations reimagine their SDLC approach, but she can deliver the services to support those recommendations and help drive positive change within all levels of IT.
Account ExecutiveLeading Software Testing Company
Account Executive
Bi-Modal Approach to transition from Waterfall to Agile SDLC Methodology
Not only did the guidance we received help us meet short term objectives, but we had a long-term strategy in place to ensure continued adoption, optimization, and continuous improvement in our regulated software testing.
Senior Director of TCOEMulti-National Biotechnology Company
Senior Director of TCOE
Holistic Approach to Software Quality Testing
The assessment and subsequent advisement we received went well beyond just tools and technology recommendations. We were able to shore up gaps in our current processes and implement an optimized solution strategy.
Director of Quality and ComplianceTop 20 Medical Devices and Healthcare Company
Director of Quality and Compliance
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Learn more about us and our services

events and conferences

Stay Tuned for Upcoming Events

GMP University

August 22-24, 2022 – San Diego (Virtual or In Person)
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Biopharmaceutical University

June 6-8, 2022 – San Diego
(Virtual or In Person)
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KENX Conference

Learn more abour KENX Conferences and take advantage of their valuable free process documents

GMP University

August 22-24, 2022 – San Diego (Virtual or In Person)
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Biopharmaceutical University

June 6-8, 2022 – San Diego
(Virtual or In Person)
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Computer Systems Validation & Software Assurance University

  • December 5-7, 2023
  • San Diego, CA
Hybrid Event
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Validation and GMP University

  • December 12, 2023
  • Puerto Rico
Hybrid Event
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