We are thrilled to announce that we are partnering with Compliance Architects (CA) to combine the power of our QbDVision Digital CMC™ software platform with CA’s deep experience in quality and regulatory compliance. Together, we plan to accelerate the development of robust manufacturing processes for pharma and biotech products by deploying digital technologies that create a solid foundation of institutional knowledge and structural compliance.
Research indicates that pharmaceutical and biotechnology companies use less than 4% of their data. Almost 80% of global warning letters cite data integrity issues. There can be turnover of 70%-80% in process development staff between the start of development and the submission for market registration challenging submission preparation. Traditional tech transfer timelines can easily exceed 24 months, further delaying commercialization. Underlying each of these statistics is a central problem in the industry: the lack of digital maturity for effective knowledge management and structural compliance over the product lifecycle. The consequences of this central problem are visible today: delayed development timelines and application rejections from regulatory authorities.
It is clear to us that our industry needs new solutions. Together, our company, CherryCircle Software, with our QbDVision platform, and Compliance Architects will offer a comprehensive, new approach.
QbDVision provides the technology backbone that organizes, aggregates, and contextualizes data to support key development processes and enable best practices. CA provides the key methods and know-how for incorporating these best practices into business processes and procedures to drive structural compliance with digitization.
What is Structural Compliance?
Creating a “culture of compliance” is a strategic objective for many management teams. This approach focuses on the people-side of the compliance equation.
Structural compliance adds the dimensions of process and technology, blending the two to create established business processes where compliance enabling activities are built into day-to-day operations leveraging fit-for-purpose technologies. This approach embeds compliance into the architecture for how work is done, creating a lasting effect.
Compliance Architects delivers technology, quality, regulatory, and compliance consulting to companies directly regulated by the United States Food and Drug Administration (FDA) through their service offerings. They have deep experience helping clients implement long-term change by modifying business processes to use digital tools, like QbDVision, to guarantee structural compliance.
To support this partnership, Compliance Architects has created specialized, cross-functional QbDVision implementation teams to address the complex business process needs for both pharmaceutical development and software adoption and use.
“Strategic organizations carefully choose their partners. Our discussions with CherryCircle have found a best-in-class platform and a team that really ‘gets’ what’s needed in today’s market. CherryCircle Software provides clients with best-of-breed solutions and services, and we are extremely excited to announce this partnership. We look forward to helping them build a robust knowledge base and drive structural compliance for successful commercialization for our shared client base.”Jack Garvey, Co-founder and Managing Partner, Compliance Architects
This is why we partnered with Compliance Architects. We feel they are uniquely positioned to help the market with digital change management and implementation.
We are thrilled about our alliance with Compliance Architects because they bring deep domain expertise, technology implementation expertise, and an understanding of best practices fully supported by our software. This partnership will enable CherryCircle Software to focus on continued expansion of QbDVision’s integrated capabilities and customer support knowing our clients are in good hands with process implementation and quality system integration. The Compliance Architects team represents an optimal partner because they share our mission of delivering 100% customer success.
We’re just getting started with our journey to transform the market. Stay tuned for more updates from our collaborations.
About Compliance Architects
QbDVision is a breakthrough CMC management platform for biopharma organizations. It’s the first and only solution that enables teams to transform fragmented data and siloed knowledge into true process intelligence: the smart, holistic guidance you need to accelerate new products to patients.
- You know where to find everything you need to streamline product development: in a structured framework that helps your teams work smarter, faster, and more collaboratively than ever.
- You know how to build robust, agile processes that your teams fully understand and control.
- You know why every input produces its output, and where they may lead to product and process risks.
Have questions? Chat with us on live chat or schedule a meeting to learn more about QbDVision.