Structure Automates Key Workflows

The ICH guidelines detail a number of requirements for pharmaceutical development (ICH Q8/Q11), quality risk management (ICH Q9), and pharmaceutical quality (ICH Q10) and how the requirements of each guidance are related to the others.  However, these activities are often handled separately with drug substance and drug product development tracked in documents/reports, risk assessments tracked in separate spreadsheets, and pharmaceutical quality tracked in eQMS solutions.  


QbDVision uses its underlying structured framework to power standard product lifecycle workflows based on best practices including quality-by-design and data-integrity-by-design. The integration of risk assessment is a key component of these best practices so the workflow starts with the definition of the risk plan which is then assigned to the corresponding project at the time of setup.  QbDVision guides you through the rest of the workflow starting with "the end in mind".  As you build the structure of your requirements and work through the risk assessments, a number of key workflows are enabled which automate compliance with regulatory requirements. 

Risk-Based Traceability

One of the biggest challenges in the industry is to readily visualize and understand cause and effect relationships between input and output variables of a complex manufacturing process (see our iSpeak article which discusses this in more detail). ICH Q8 specifically calls for this deeper process understanding: 


  • Identify (through, e.g., prior knowledge, experimentation, and risk assessment) the material attributes and process parameters that can have an effect on product CQAs

  • Determine the functional relationships that link material attributes and process parameters to product CQAs

Furthermore, ICH Q9 Annex II (II.3 Quality Risk Management as Part of Development) describes the application QRM principles to assess the criticality of quality attributes, process parameters, and other process variables. 

QbDVision allows for these requirements to be met within one software platform providing integration and transparency.  Eliminate your spreadsheets, fishbones, and flowcharting tools and let QbDVision help you provide visibility into complex processes and automate compliance. 

Define RMP

Define Requirements with Risk

Interactive Risk Table

Interactive Risk Map

Automated Reporting

Whether you are drafting a Target Product Profile (TPP), a Quality Target Product Profile (QTPP), or a Risk Management Plan, it often takes a significant amount of time to assemble this draft when your information is dispersed in multiple systems.  The integration provided by QbDVision allows it to follow the 80/20 rule where it can do 80% of the work for you and you only have to spend the remaining 20% of the time fine-tuning the document with export to Word or PDF for your specific needs.  Who doesn't want to save 80% of their time so they can work on the things they really like to do! The QTPP is a classic example of a report that can take an inordinate amount of time to draft and keep current.  QbDVision generates this report in real-time at the click of a button assembling information from within the system to generate a comprehensive report in seconds. 



Process Flow

Risk Assessment

Raw Material Management

Raw material variability can have significant impacts on your manufacturing process causing issues with performance, yield, and ultimately product quality which impacts patient safety and expected drug efficacy. With the increasing complexity of pharma and biotech manufacturing processes, it is becoming more challenging to track raw material variability and understand its impact on these processes.

A significant challenge with raw material management is variability within a wide specification range. There are many instances where a supplier process change causes a significant change in the value of a material attribute that is not out-of-specification but still disrupts your process. Without data tracking and analysis tools, you are not likely to catch these deviations. The automated data extraction and storage workflow enabled by QbDVision solves this problem. With data tracked for each received lot and organized by manufacturing date, a running mean and SD can be calculated. Each new lot can be compared against these values to automatically flag and report a large change BEFORE you use this lot in your process.

Defined Material Attribute Taxonomy

CoA Upload & Extraction


Automated Outlier Detection

Investigating Cause & Effect

One of the biggest challenges during the product development lifecycle is the management of deviations from established specifications or the assessment of changes to your established process.  Standard tools used to evaluate cause and effect such as process flow maps or Ishikawa diagrams are poor at showing direct relationships between inputs and outputs of your manufacturing process. The risk-based traceability tools included with QbDVision dramatically improve the visualization of cause and effect for deviation investigations and impact assessment analyses.  View the full risk map to get a picture of cause and effect that follows the process from raw materials through unit operations to product attributes and patient requirements.  Search for the variable that is the source of the deviation or affected by a component or material change.  Select the Upstream filter to see which inputs will affect this variable.  Then select the Downstream filter to see the outputs affected by this variable.  This risk-based visualization of input to output variables can be very helpful with the new lifecycle management requirements of ICH Q12.   

View Full Cause & Effect Map

Identify Deviation or Change

Visualize Input Variables 

Visual Downstream Impacts


CherryCircle Software, Inc.

2101 E. St. Elmo Road 

Building 1, Suite 100

Austin, TX, 78744


© 2017-2021 CherryCircle Software

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