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
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
Established 2005; > 100 EmployeesIn 2006, Partnered with Ness
Technologies (2500+ employees)
Installed and used by top tier pharma, biotech and chemical organizations.
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
> 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
Experiments
Project Management
Inventory
Notifications
Requests
Planning
Reports
Skyline Modules
Workup / Self-test
Action
Step
Experiment
Sub-project
ProjectRe
ques
ts
Sam
ples
Inve
ntor
y
Data Model
Synthesis
Analytics
Formulation
Parametric
Pilot
Information and Task Flow
• Requests• Tasks
- Samples- Inventory- Equipment- Employees
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
Business Rules
We were able to implement complex business rules in a way that will guide the user and not bring additional overhead.
• 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
• 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:
• 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
• 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
Summary
Operational excellenceReduced time to market
Covers end-to-end R&D projects User friendly Implements complex business rules and workflows Highly integrated Secure
