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.
Business Benefits
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.
Regulatory Submissions
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
receiving units.
DTLS ROADMAP
Q4 2021
Segment Groups
- Build composite segments to further characterize segmentation data.
Test Methods
- Add to core data model.
Process Parameters
- Allow users to fully customize Process Parameters for any business need.
Create with Reference
- Allow Processes to be created with a reference to an existing Process, copying relevant data.
Site & General Processes
- Differentiate between General and Site Processes and integrate Site Processes to SAP Plant.
Calculation Builder
- Overhaul UI/UX to be more clear, intuitive, and useful.
Integration with SAP MM
- DTLS uses both materials from the SAP Material Master as well as staged materials created within DTLS.
Q1 2022
Lead Times
- Add to the core data model.
Process Builder 2.0
- Upgrade to allow new features such as complete process flow mapping, new drag and drop capabilities, and overhauled step editing.
Data Quality
- Improve data quality through stronger creation requirements.
New – Handover to Manufacturing: Process.
- Add ability to map a DTLS process to an SAP Master Recipe.
- Add ability to create & maintain an SAP Master Recipe from a DTLS Process.
Q2 2022
Product Lifecycle Stage
- Add to the core data model.
Additional Attributes
- Allow users to add additional characteristics & attributes to any object in the core data model.
Equipment Requirements
- Add Equipment Requirements to the core data model.
Create with Reference: BOM
- When creating a Process by reference, allow the BOM to be copied over as well as the base process data.
Object Timeline
- Overhaul design notes to show a timeline, including system events and messages.
New – Change Approvals Workflow: Configuration.
- Allow users to customize the change control parameters for approvals by object type, criticality, lifecycle stage, and more.
Core API Services
- Add core API services for Process, Unit Operation, Step, Process Parameter.
Q3 2022
Data Quality
- Improve data quality through strong data validations.
New – Relationship Explorer.
- Visualize relationships from end-to-end. Highlight and trace impacts.
Upgrade SAP UI5 Version
- Add button badges to design notes, tags, segments, relationships to show how many of each exist.
- Add illustrated messages to provide clarity to users when data is empty, missing, or not found etc.
- Complete overhaul of the Fiori Launchpad for DTLS including the use of spaces, pages, and new tile types such as analytics tiles, etc.
Integration with SiMPL MES for R&D execution.
- Record results of R&D runs against a DTLS Process, including Process Parameters and Quality Attributes
New Application – Handover to Manufacturing: BOM
- Add ability to transfer a DTLS BOM to an SAP BOM for manufacturing.
Handover to Manufacturing: Process
- Send Process Parameters and Critical Quality Attributes to manufacturing for R&D runs.
Q4 2022
Resource
- Add to the core data model.
Risk Management
- Allow users to attach Risk to any object in the core data model.
New – Product Lifecycle Workflow: Configuration.
- Configure the product lifecycle workflow and how Processes move through it.
SAP BTP Workflow
- Migrate workflows to SAP BTP.
Analytics
- Add analytics dashboard for Critical Quality Attributes, Process Parameters, Relationships, and SiMPL R&D execution data.
Object Tagging
- Overhaul tags to be more searchable, filterable, and enable tags to drive user-based content scenarios.
Core API Services
- Add core API services for the rest of the data model.
Analytics API
- Creation of an analytics API for self-service report building and integration with third-party analytics platforms.
2023
GxP Compliance
- CI/CD Pipeline for GxP Cloud Compliance.
DTLS Cloud Core
- Migrate core data model to SAP BTP for complete cloud solution.
Application Configuration
- Improve the configurability of the DTLS product suite.
Time Slider
- Enhance Time Slider with a more specialized UI/UX.
Where-Used Features
- Enhanced where-used and replace for aliases, calculations, relationships etc.
New - My Tasks.
- Application for users to view and execute tasks such as approvals.
Analytics
- Analytics report based on attachable Risk.
Integration with SAP EPD.
- Integrate with SAP EPD on Specifications etc.
Equipment Requirements & Resource
- Send Equipment Requirements, and Resources to manufacturing.
Segmentation
- Add segmentation data to the core process handover.
New – CMO Portal for Tech Transfer
- Hosted on AWS, build a portal for CMO/CDMO access to customer DTLS for tech transfer
Segmentation
- Add segmentation data to the core process handover.