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Blog

Digitally Managing the Evolution of Your QTPP

The Quality Target Product Profile or QTPP is a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account the safety and efficacy of the drug product.

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Blog

First Time Right: The Key to Effective Product & Process Development

Our industry faces numerous challenges related to scaling manufacturing processes for cell and gene therapies. Explore some key recommendations and potential solutions.

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Blog

CherryCircle Software Raises $2MM in Additional Seed Financing

Yes indeed, CherryCircle just knocked out an additional round of seed financing. Combined with our last raise, brings our total fundraising to around $4.6M.

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ICH, QbD, Pharma 4.0: One and the Same

There is a consistent theme that comes up in the world of pharmaceutical process development and validation: a pervasive confusion around how ICH guidelines match up with quality-by-design principles.

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QbDVision Release: Leading the way in digital transformation for PLM

We’re excited to announce the next major iteration to QbDVision. Designed and validated top to bottom to bring you the latest tools to advance your pharmaceutical manufacturing activities.

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Putting It All Together: Process Risk Assessments (Part 7)

See how our platform builds risk in discrete layers that are designed to be updated and managed throughout the development lifecycle thus capturing the evolution of risk.

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Risk Management Plan Configuration: Process Risk Assessments (Part 6)

Explore how the structure of risk configuration in QbDVision produces easily understandable assessments to guide future work.

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The Non-Linear Factor: People – Process Risk Assessments (Part 5)

Last week, we saw how capturing uncertainty and detectability risk brings clarity and dimension while assessing risk when used appropriately. This week, we will look at the practical aspects of process risk assessments from a different lens: that of the people executing or using these tools.

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The Impostors: Uncertainty and Detectability Risk – Process Risk Assessments (Part 4)

Last week we explored how the concepts we’ve been discussing in our series line up with FMEA/FMECA methodologies. This week, we’ll explore the two impostors, uncertainty and detectability risk, a little bit further.

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