Features

 knowledge management by Design

Feature-rich software to manage your process knowledge

Secure
Easy-to-Use

QbDVision has been built to provide significant functionality without layers of complexity.  Instead of being built by engineers for engineers, it is built by drug developers, manufacturing experts and quality assurance managers.  The result is an intelligent management tool with an intuitive user interface that is easy-to-use with minimal training.

Secure

As a cloud-based solution, security is of the utmost importance to ensure data integrity and protection of intellectual property.  Running on Amazon Web Services, security of the hardware and software that make up the cloud infrastructure is provided by the latest technologies deployed at AWS.  To maintain the security of the QbDVision application and your data, we utilize the latest 256-bit encryption technology to keep your data encrypted at rest and in transit. 

21 CFR 11 Compliant

QbDVision is intended to simplify the management of your drug manufacturing process and each piece of data is managed through change control with audit trails and record histories.  With all changes to data in the system requiring approval routing and electronic signatures, we ensure compliance with 21 CFR Part 11 and ensure data integrity which is one of our highest priorities.  

Validated

With a serverless architecture that allows for rapid production scale testing, the traditional, lengthy cycles of IQ, OQ, and PQ are gone.  The serverless paradigm means that the application is served from the cloud and installation is effectively instantaneous.  Add to that the novel automated and validated testing tools we are using and software revisions can be tested in a matter of hours.  

Requirements Management
Define Process Requirements
Establish Acceptance Criteria
Perform Risk Assessment and Mitigation
Evaluate Risk Control 
Determine Process Capability
Track Requirements History
Process Explorer
Create Process Flow Maps
Define Unit Operations
Track Materials and Attributes
Define Components and Equipment
Track Process Parameters
Qualify Materials and Equipment
Risk Analysis
Criticality Based on Impact and Uncertainty
Detectability Risk and RPN
Capability Risk and Composite Risk Score
Risk Tables by Unit Operation
Supplier Risk
Color-Coded Risk Maps
Control Methods and Testing
Define Control Methods for Each Requirement
Track Method Qualification and Validation
Set Critical Control Points and Sampling Plans
Attach Protocols, References, and Standards
Easily Identify Gaps in Testing
Quality-by-Design
Data Integrity-by-Design
Knowledge Management-by-Design
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LINKS
ABOUT

CherryCircle Software, Inc.

1601 Trinity Street, Building B

Austin, TX, 78712

info@qbdvision.com

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