WHAT IS DTLS™?
The Digital Thread for Life Sciences™ (DTLS) is a product information framework that integrates people, data, processes and business systems to drive efficiency and continuity through the drug development lifecycle.
DTLS Product Lifecycle Management (PLM) includes Process Builder & Tech Transfer which combines as a powerful & intuitive PLM tool for Life Sciences. With Process Builder, organizations can create, manage & consolidate Process knowledge in order to streamline operations such as Tech Transfer.
Quality Risk Management
Assessment, control, communication and review of risks to the quality (safety, efficacy) of the drug product across the product lifecycle.
Design Space Management
Defining operating ranges and relationships for parameters, material attributes, to establish and evaluate CQA Impacts.
Analytics and Data Correlation Insights
DTLS Batch Execution Run drive Machine Learning data correlation insights for CQAs though SAP BI and Industry 4.0.
Knowledge Management and Control Strategy Governance
Change Management, Impact Analysis, CMC, Workflow, and overall process Knowledge Management with KASA framework.
Generating formatted, configurable regulatory submission documents through SAP Adobe Forms.
Tech Transfer/Facility Fit
Packaging Tech Transfer Plan, Package and Protocol to digitally bridge sending and