skyline scientific data management platform
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SkylineScientific Data Management Platform
for Specialty Chemicals R&D
Gai Anbar, Founder & CEO March 2018
MarvinJS at an Agrochemical Company
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About Comply
Developer of Skyline - the only single platform supporting end to end product
development - from conception to production
A leading provider of consulting services in Computerized Systems Validation, Data
Integrity and IT QA
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Established 2005; > 100 EmployeesIn 2006, Partnered with Ness
Technologies (2500+ employees)
Installed and used by top tier pharma, biotech and chemical organizations.
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Skyline Specialty Chemicals is a platform designed to manage and analyze chemistry based R&D
from idea to production
What is Skyline
Developed by Comply closely with our customers, resulting in a novel Process & Scientific Data Management system.
• Project, study and experiment management
• Information flows from synthesis to analytics to formulation and to Pilot production
• Protocol execution & data entry• Manufacturing monitoring &
process improvement• Sample Management• Requests and workflows• Test Results
• Task management• Inventory management• Equipment and instruments• IP & documentation• Statistical process control and Trends
analysis• Advanced calculation engine• Electronic signatures• Notifications• Supports Data Integrity, 21 CFR Part
11, Annex 11 requirements
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> 15,000 experiments and production batches> 1,500,000 results, production parameters and raw materials> 100 processes> 500 different parameters are analyzed> 200 complex formulas
Case StudyLarge Biotech company
Small scale Production Purification Formulation Analytics Stability Upscale
Process development of new biotech product:
Achievement:
reduction of 2.4 months in R&D product development
Data as for March 2016 and growing fast
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Every year:> 100 projects> 20,000 experiments and production batches> 10,000 inventory items> 100,000 documents> 1,000,000 calculations
Case StudyLeading Agrochemical company
Project Management
History research
Organic Synthesis Analytics Formulation Pilot
production
R&D from idea to pilot production
Highly integrated platform to streamline R&D in a competitive market
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Experiments
Project Management
Inventory
Notifications
Requests
Planning
Reports
Skyline Modules
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Workup / Self-test
Action
Step
Experiment
Sub-project
ProjectRe
ques
ts
Sam
ples
Inve
ntor
y
Data Model
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Synthesis
Analytics
Formulation
Parametric
Pilot
Information and Task Flow
• Requests• Tasks
- Samples- Inventory- Equipment- Employees
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New Project New Organic Experiment
Create Inventory from experiment Create Sample
Create Request for analysis
Analysis experiment from
Request
Return analysis results into Organic
Experiment
Tight Integration
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Business Rules
We were able to implement complex business rules in a way that will guide the user and not bring additional overhead.
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• Global organization: HQ, sites, business units and departments
• Multiple users and roles (managers and workers)
• Different access levels
• Intellectual property protection
• Regulatory compliance
Information Security
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• Draw reactions• Identify reactants and products• Chemical structure of inventory items• Chemical property calculations• Search the inventory based on structure & properties:
• Search & View inventory items• Search for similar compounds as part of product development
Next: • Interface to commercial databases• Additional, deeper tools
Use of MarvinJS
ChemAxon MarvinJS and back-end components are key elements:
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• Web based
• Dynamic dashboards
• Personalized user preferences
• Tasks and notifications
• Powerful search engine
• Spreadsheet and chemical editor components
• Easy system customization to meet business needs
Flexible and User Friendly
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• Skyline is developed under the very strict methodologies of the Pharma world
• Complies with FDA 21 CFR Part 11& and EU Annex 11 requirements including electronic signatures
• Full audit trail
• Safety and employee training support
Quality Assurance
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Summary
Operational excellenceReduced time to market
Covers end-to-end R&D projects User friendly Implements complex business rules and workflows Highly integrated Secure