L7 | Precision Therapeutics
accelerate cell & gene therapy processes with workflow automation and data compliance
digitalize research-to-commercialization
To enable scalability with compliance in Cell & Gene Therapy (CGT) processes, fast-growing BioTech organizations need a unified composable, and cloud-agnostic IT platform. Improve data integrity with connectivity, RWD/RWE capture, and collaboration. The L7 | Precision Therapeutics solution can strengthen the understanding between process, product, and patient outcomes – from research-to-commercialization.
L7 Precision Therapeutics workflow
business benefits
VELOCITY
-
accelerate sample-to-drug
EFFICIENCY
-
easy to implement and user-driven
-
no rip and replace of existing systems
COMPLIANCE
-
CFR part11/GCP/GMP
solution capabilities
INTEGRITY
-
single data and process automation platform
-
integrated and validated environment
-
strengthen the understanding between process, product, and patient outcomes
COLLABORATION
- better collaboration between all stakeholders
CONNECTIVITY
-
software
-
environmental monitoring
-
bio-process equipment
-
quality control instrumentation
solution packages
L7 | Precision Solutions are delivered as pre-configured packages of select L7 apps + curated scientific-industry content – plus, a team of experts to support your digitalization journey. L7 enables you to ‘start small and scale fast’ from any starting point – from research-to-commercialization.
L7 PRECISION THERAPEUTICS
lab
digitalize lab operations
Design, execute, and report quality control laboratory operations to a GMP QC level. Capture quality and business decisions.
L7 BUSINESS APPS
- LIMS
- ENVIRONMENTAL MONITORING (EM)
- INVENTORY
- LOCATIONS
- SCHEDULING (QC)
- STABILITY
- TRACKING AND LOGISTICS
- VALIDATION (Method)
L7 SOLUTION CONTENT
- CONNECTORS (Software)
- CONNECTORS (Instrument)
- STANDARD METHODS
- REPORTS
- ROLE AND ACCESS PROFILES
- STANDARD ENTITY TYPES
L7 STANDARD APPS
L7 Precision Solution Packages include a pre-configured set of L7 | ESP Standard Apps.
L7 | LIMS directs Entities; Samples, Inventory, Assets, etc. through processing steps in workflows and across workflow-chains.
DIGITAL-FIRST IMPLEMENTATION
L7 Precision Solution Packages include ‘Digital-First’ implementation methodology, value-driven roadmapping tools, and a collaborative L7 University curriculum crafted by L7 Services scientists and engineers.
L7 PRECISION THERAPEUTICS
manufacturing
design and execute controlled manufacturing processes
Capture, report, and store all operations data and results to a cGMP compliant level. Capture quality and business decisions.
L7 BUSINESS APPS
- MANUFACTURING EXECUTION SYSTEM (MES)
- INVENTORY
- PERSONNEL
- VALIDATION – Process
- LOCATIONS
- SCHEDULING – Manufacturing
- PLANNING
- ASSETS
- TRACKING AND LOGISTICS
L7 SOLUTION CONTENT
- CONNECTORS – Software
- CONNECTORS – Instrument
- STANDARD UNIT OPERATIONS
- REPORTS
- ROLE AND ACCESS PROFILES
- STANDARD ENTITY TYPES
L7 STANDARD APPS
L7 Precision Solution Packages include a pre-configured set of L7 | ESP Standard Apps.
L7 | MANUFACTURING EXECUTION SYSTEM (MES) to integrate equipment, automate calculations, track inventory consumption and asset usage. Full support for part 11 compliant signatures and PDF generation of batch records after completion.
DIGITAL-FIRST IMPLEMENTATION
L7 Precision Solution Packages include ‘Digital-First’ implementation methodology, value-driven roadmapping tools, and a collaborative L7 University curriculum crafted by L7 Services scientists and engineers.
L7 PRECISION THERAPEUTICS
cell supply
track cell lines from source to storage
Generate repeatable controlled processes to fully track cell lines from source, to expansion, to fill and storage.
L7 BUSINESS APPS
- MANUFACTURING EXECUTION SYSTEM (MES)
- INVENTORY
- PERSONNEL
- VALIDATION – Process
- LOCATIONS
- SCHEDULING – Manufacturing
- PLANNING
- ASSETS
- TRACKING AND LOGISTICS
L7 SOLUTION CONTENT
- CONNECTORS – Software
- CONNECTORS – Instrument
- STANDARD UNIT OPERATIONS
- REPORTS
- ROLE AND ACCESS PROFILES
- STANDARD ENTITY TYPES
L7 STANDARD APPS
L7 Precision Solution Packages include a pre-configured set of L7 | ESP Standard Apps.
L7 | MANUFACTURING EXECUTION SYSTEM (MES) to integrate equipment, automate calculations, track inventory consumption and asset usage. Full support for part 11 compliant signatures and PDF generation of batch records after completion.
DIGITAL-FIRST IMPLEMENTATION
L7 Precision Solution Packages include ‘Digital-First’ implementation methodology, value-driven roadmapping tools, and a collaborative L7 University curriculum crafted by L7 Services scientists and engineers.
L7 PRECISION THERAPEUTICS
clinical
replace paper-based planning and tracking
Organize and schedule patients, sites, studies and regulatory submissions.
L7 BUSINESS APPS
- CLINICAL OPERATIONS
- TRACKING AND LOGISTICS
L7 SOLUTION CONTENT
- CONNECTORS – Software
L7 STANDARD APPS
L7 Precision Solution Packages include a pre-configured set of L7 | ESP Standard Apps.
L7 | CLINICAL OPERATIONS manages the vein-to-vein chain of identity and chain of custody – with real-time visibility to all clinical-trial sites and logistics.
DIGITAL-FIRST IMPLEMENTATION
L7 Precision Solution Packages include ‘Digital-First’ implementation methodology, value-driven roadmapping tools, and a collaborative L7 University curriculum crafted by L7 Services scientists and engineers.
L7 PRECISION THERAPEUTICS
development
analytical and process development
Design, execute, and report development studies in preparation for transfer to GMP operations. Capture quality and business decisions.
L7 BUSINESS APPS
- ELECTRONIC LAB NOTEBOOK (ELN)
- INVENTORY
- DESIGN OF EXPERIMENT (DOE)
- VALIDATION – Process
- LOCATIONS
- ASSETS
- STABILITY
L7 SOLUTION CONTENT
- CONNECTORS – Software
- CONNECTORS – Instrument
- STANDARD METHODS
- STANDARD UNIT OPERATIONS
L7 STANDARD APPS
L7 Precision Solution Packages include a pre-configured set of L7 | ESP Standard Apps.
L7 | ELECTRONIC LAB NOTEBOOK (ELN) captures data while executing unstructured experiments for research and protocol / method / assay development.
DIGITAL-FIRST IMPLEMENTATION
L7 Precision Solution Packages include ‘Digital-First’ implementation methodology, value-driven roadmapping tools, and a collaborative L7 University curriculum crafted by L7 Services scientists and engineers.
L7 PRECISION THERAPEUTICS
drug discovery
correlate findings from research to potential targets
Extend findings from research and correlate with disease mechanisms and potential targets to disrupt or correct using biologics or C> methods.
L7 BUSINESS APPS
- ELECTRONIC LAB NOTEBOOK (ELN)
- INVENTORY
- DESIGN OF EXPERIMENT (DOE)
- LOCATIONS
L7 SOLUTION CONTENT
- CONNECTORS – Instrument
- STANDARD METHODS
L7 STANDARD APPS
L7 Precision Solution Packages include a pre-configured set of L7 | ESP Standard Apps.
L7 | ELECTRONIC LAB NOTEBOOK (ELN) captures data while executing unstructured experiments for research and protocol / method / assay development.
DIGITAL-FIRST IMPLEMENTATION
L7 Precision Solution Packages include ‘Digital-First’ implementation methodology, value-driven roadmapping tools, and a collaborative L7 University curriculum crafted by L7 Services scientists and engineers.
L7 PRECISION THERAPEUTICS
research
explore disease pathways + tools and techniques for investigation
Capture experiments and collaborate on tasks across research groups.
L7 BUSINESS APPS
- ELECTRONIC LAB NOTEBOOK (ELN)
- DESIGN OF EXPERIMENT (DOE)
- LOCATIONS
L7 SOLUTION CONTENT
- CONNECTORS – Instrument
- STANDARD METHODS
L7 STANDARD APPS
L7 Precision Solution Packages include a pre-configured set of L7 | ESP Standard Apps.
L7 | ELECTRONIC LAB NOTEBOOK (ELN) captures data while executing unstructured experiments for research and protocol / method / assay development.
DIGITAL-FIRST IMPLEMENTATION
L7 Precision Solution Packages include ‘Digital-First’ implementation methodology, value-driven roadmapping tools, and a collaborative L7 University curriculum crafted by L7 Services scientists and engineers.
related resources
Precision Therapeutics
PACT Pharma: Cell & Gene Therapy Platform
ARMI: Regenerative Medicine
Composable Architecture Enables Digital Transformation for Data-Driven Organizations
L7|ESP for Precision Therapeutics
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