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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.

LAB OPERATIONS
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.

MANUFACTURING OPERATIONS
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.

CELL SUPPLY OPERATIONS
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.

CLINICAL OPERATIONS
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.

DEVELOPMENT OPERATIONS
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.

DRUG DISCOVERY
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&GT 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.

RESEARCH OPERATIONS
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.

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L7 services

When you become a customer, you'll be granted full access to L7 | University, an incredibly rich library of proprietary content and training resources.
EXPLORE
L7|ESP is an adaptable and customizable platform that streamlines process execution, provides a complete chain of custody from sample to report, and enables management of complex workflows.

Simon Hughes, Associate Director, CDx Assay Development, QIAGEN

L7|ESP provides a single platform to assure both control and compliance, while providing a seamless transfer of clinical operations to manufacturing operations.

Ernie Bognar, Chief Operations Officer, Gradalis, Inc.