Exemplar Compliance and CherryCircle Form Strategic Relationship to Promote Industry Adoption of QbD

Austin, TX, May 2019 – Today CherryCircle Software, the company providing the pharmaceutical industry with simple, but powerful, tools to facilitate robust manufacturing process development, and Exemplar Compliance, a leading consulting firm specializing in quality, validation, and regulatory compliance, are announcing a relationship to accelerate the pharmaceutical industry’s adoption of Pharma 4.0, utilizing the best practices of Quality-by-Design (QbD) and Data Integrity-by-Design. This collaboration will help the industry move closer to achieving greater patient quality and safety at lower costs.

Exemplar’s QbD implementation experience will be combined with the unmatched visibility and insight provided by CherryCircle’s QbDVision® software platform. Exemplar Compliance will help industry participants implement Pharma 4.0 and execute Quality-by-Design programs leveraging their proprietary best practices built specifically to take advantage of QbDVision’s embedded intelligence, knowledge graph technology, and spatial analytics.

Implementation of the QbDVision software solution will help pharmaceutical companies maximize their return on investment. As part of the relationship, Exemplar Compliance will provide strategic input back to the QbDVision teams for the benefit of the broader industry, and will be assisting with technical publications discussing implementation of the QbDVision software.

“Our goal has always been to implement practical quality and compliance solutions to drive down costs and bring life saving technologies to market. CherryCircle’s QbDVision structured knowledge management solution aligns perfectly with these goals, and we are excited to put it to use for the benefit of our global customers,” said Rebecca Waterbury, Founder and VP of Quality and Compliance at Exemplar Compliance. “Having a solution that is fully validated and 21 CFR Part 11 compliant means that we can use it in drug development, clinical and commercial applications.”

Quality by Design is a systematic approach to pharmaceutical development and manufacturing that emphasizes product and process understanding and knowledge, quality risk management, and process control. This framework has been promoted by the United States FDA and other international regulatory bodies for process development and validation, and is the foundation of the effort to bring the Industry 4.0 principles of science and data-driven development to the pharmaceutical industry.

“Exemplar Compliance is a thought leader and driver of strategic transformation within our industry,” said Yash Sabharwal, President and CEO, CherryCircle Software. “Together we can help change the status quo approaches of ‘Quality-by-Documentation’ or ‘Quality-by-Compliance,’ and move forward with data-driven methodologies to enable Quality-by-Design.”

Upcoming Webinar “Improving Final Product Quality by Embracing Knowledge Management Throughout the Product Lifecycle”

Exemplar Compliance and CherryCircle Software will host a joint webinar on June 11, 2019, to further discuss how QbDVision brings together ICH Q8, Q9, Q10, Q11, and Q12 under one platform. Attendees will learn how pharmaceutical manufacturers can:

  • Build a knowledge base throughout your product lifecycle
  • Easily link patient, product, and process requirements
  • Integrate risk and process capability to gain a deeper understanding
  • Visualize risk to assess deviations and process changes

To learn more and register for the webinar, please visit here.

About Exemplar Compliance

Exemplar Compliance is a full-service consulting firm that specializes in quality and regulatory support for the life science industry. Our consultants have an average of 25 years of experience and work side by side with our clients to deliver value added services. We provide quality and regulatory support for both large and small companies in all phases of development and manufacturing. Typical services include:

  • Quality System Development & Implementation
  • Quality by Design (QbD)
  • Internal Quality Audits
  • Vendor Quality Audits (CSP, CMO, APIs, Distributors, etc.)
  • Gap Assessment and Remediation
  • FDA Inspection Preparation and Response
  • ISO and Notified Body Inspection Readiness
  • Clinical and Commercial Manufacturing Support
  • Clinical Quality Support
  • FDA registration and submission support

Our team of industry experts and former FDA inspectors and officials works to provide customized, compliant solutions for our clients. For more information, visit www.ExemplarCompliance.com.

About QbDVision and CherryCircle Software

CherryCircle Software, Inc. builds cloud-based solutions that help companies manufacture the highest quality drugs, reducing the development time and increasing the availability of essential therapies for patients. Its flagship product, QbDVision, provides the pharmaceutical industry with simple, but powerful, tools to facilitate robust manufacturing process development. QbDVision is powered by automation and innovation, driven by data and science, and enabled by people under the quality-by-design (QbD) and data integrity-by-design (DIbD) frameworks. Founded in 2016 by pharmaceutical manufacturing and quality experts, CherryCircle Software is headquartered in Austin, Texas, and is an active member of the International Society for Pharmaceutical Engineering (ISPE). For more information, visit our website.

Exemplar Compliance Contact

Joy Langley
Director of Operations
QbDVision Relationship Contact

Kevin Schfrin
Chief Business Development Officer