Analytical Procedure Management
Manage the entire lifecycle of analytical procedures
Define, develop, and maintain analytical procedures within one connected Digital CMC knowledge foundation.
Connect product, process, and analytical knowledge
Connect procedure knowledge
Connect product quality attributes, manufacturing knowledge, Analytical Target Profiles, and analytical procedures in one environment.
Maintain end-to-end traceability
Trace requirements from quality attributes and ATPs through performance characteristics, analytical attributes, procedure parameters, and supporting documentation.
Build a regulatory-ready foundation
Standardize analytical procedures to support lifecycle management, regulatory consistency, laboratory harmonization, and AI-enabled knowledge discovery.
Overview
A dynamic, interconnected system
QbDVision connects product, process, and analytical procedure knowledge in one dynamic, interconnected system. Instead of managing SOPs, validation protocols, and development records with static documents, teams work from connected Digital CMC knowledge foundation that keeps development labs, QC sites, and regulatory teams aligned throughout the product lifecycle.
Procedure definition
Build a digital analytical target profile
Capture analytical procedure requirements and acceptance criteria in a structured digital model.
Link product quality attributes to the performance characteristics used to evaluate whether a procedure is fit for purpose.
Use ATP requirements and performance criteria to support procedure selection, development, and evaluation.
Procedure management
Manage procedure elements
Capture analytical procedure structure, unit operations, steps, procedure parameters, equipment, materials, and intermediate performance attributes in one connected system.
Classify Analytical Procedure Attributes and Procedure Parameters by criticality and document qualitative risk assessments alongside procedure development.
Trace relationships from product quality attributes and ATP requirements through Performance Characteristics, Analytical Procedure Attributes, Materials, and Procedure Parameters.
Link source documentation and supporting evidence directly to relevant process and procedure records.
Build a reusable analytical knowledge foundation that reduces redevelopment as products, sites, and development programs evolve.
Regulatory submission
Generate data-linked living documents
Export structured analytical procedure development content for documentation, collaboration, and review.
Create procedure maps, knowledge graphs, and risk views that help teams understand relationships across analytical development.
Real-world impact for CMC teams
Centralize
knowledge management across the procedure lifecycle
Improve
method reliability
Reduce
time spent creating regulatory documentation
Beyond implementation
A people-first approach to analytical procedure management
We partner with pharma and biotech teams to build a platform that enables you to easily develop, test, validate, and transfer analytical procedures.
We’re here to help you deliver