New release: Agile process development and tech transfer

If software releases were like your favorite TV series, get ready to start binge-watching Season 5 of QbDVision! (Editor’s note: Season 5 means our 5th major release.)

Season 5 is titled Electronica and follows our popular release from the summer of 2020.

Our new release boasts many new capabilities designed and validated from top to bottom to simplify your process development and tech transfer activities.

Episode 1: Expansion of TPP/Product Monograph

Season 5 kicks off with the Target Product Profile (TPP) or Product Monograph. The TPP is a compilation of all the information critical to understanding the requirements of the product with respect to patient safety and efficacy, storage, handling, etc. You now have the ability to customize and add to your Target Product Profile (TPP) section list.

The default list comes from the TPP Guidance provided by the FDA. With this new flexibility, section names can be changed, archived, and new sections can be added as needed. This makes it easier to customize the TPP for your own purposes or regulatory requirements.

Episode 2: Expansion of the QTPP

Before this release, the Quality Target Product Profile (QTTP) only allowed for the definition of product quality attributes.

QTPPs now include general attributes of the product such as Dosage Form, Route of Administration, etc. Furthermore, there are attributes descriptive/indicative of the performance of a product or process. These attributes are separate from product quality that need to be tracked as well.

Our QTPP functionality accommodates all three definitions and management; General, Quality, and Performance Attributes!

The session storyline is getting very exciting because this expanded capability also expands your risk assessment tools…but you have to wait to see the next episode to know how!

Episode 3: Risk Ranking Support

In this episode, a major conflict arises with respect to risk assessment. How can I assess a product quality attribute against multiple categories of patient safety and efficacy such as PK/PD, bioavailability, or immunogenicity.

QbDVision resolves this conflict by leveraging the new General Attributes from the QTPP. Define your specific safety and efficacy categories as General Attributes, set up your project to use our new Risk Ranking functionality, and Voila! Product (final) quality attributes can be separately assessed for risk against each General Attribute.

It was a narrow escape, but all’s well that ends well in Episode 3.

Episode 4: Multiple Processes

The scene shifts from the product side to the process side in Episode 4.

The process side of town is rough, complicated, and messy. But, QbDVision is a force for gentrification where it is sorely needed. QbDVision is an accelerant now providing the ability to define multiple processes within a single project. As your processes evolve in scale and complexity from early PD to characterization and qualification, QbDVision makes it easy to leverage the learning from one process to the next.

The ramifications for simplifying tech transfer are HUGE! Define all the elements of your process at one site/scale (requirements, variables, materials, equipment, etc.) and then quickly copy and modify for another site/scale. With the click of a button, you will generate future reports comparing the differences and completing in-line risk assessments on these differences. Wow! The process “neighborhood” is starting to look pretty good!

Episode 5: Support for Single Sign-On (SSO)

When your town was small, you could leave the doors to your house unlocked. But, the town is growing, and so is the need for security. QbDVision has always put security first, and now we have further enhanced platform security with support for Single Sign-on (SSO) with SAML 2.0 for customers of our Enterprise IT package.

This additive offering allows QbDVision’s powerful software to seamlessly integrate with any security infrastructure requirements and enable data monitoring within our cloud-based environment. Giving IT administrators greater control, visibility, policy management, and security enforcement.

Combined with our leading-edge security practices and robust encryption, SSO ensures data in the neighborhood (your data) is always safe and secure. QbDVision is validated software and compliant with all ISO security standards built upon the widely used AWS platform that many large organizations – including the FDA – are using today.

Neighbors (our users) can now easily walk between houses using their company credentials making IT staff happy and everyone’s life a little easier.

Season Finale: New Data Management Module

Season 5 of QbDVision ends with constructing a brand new module for the management of product, process, and material data.

Previously, data specific to requirements was included in the requirement record. This is limited flexibility from a management and analytics perspective. The data management module has been completely revamped so that all data sits separately but is still linked to its relevant requirements.

  • Data Sources – Batch data and certificate of analysis (CoA) data will now be handled as separate groups of information with links to the associated attributes or parameters instead of being integrated within the attribute/parameter records.
  • Continuous Data Support – We have added the capability to store and analyze time-series data with our visualization tools.

As Season 5 ends with the new data management module’s unveiling, viewers are left with a cliffhanger: what does this mean for future analytics capabilities in QbDVision?

Stay tuned, and you will find out in Season 6!

If you are new to QbDVision and interested in trying out our solution, reach out today and learn more about exploring the platform’s expanded capabilities.