Zenith Technologies
ISPE GAMP COP IRELAND
Outsourced Automation and
Validation
17 Oct 13
Questions
Why have an outsourced model
What is an outsourced model
How to introduce an outsourced model
©2013 Zenith Technologies
Zenith Technologies - Quick Facts
Privately Owned Company
Head Office: Cork, Ireland
Founded: 1998
Total employment: ~400
14 Offices Worldwide
Life Sciences Primary Focus
Global Provider of Automation Managed Services
©2013 Zenith Technologies
Why have an outsourced model?
Background
Life science industry needs to be more agile (especially in Ireland!)
e.g. multiple product entries
Drive to reduce Headcount/Cost
Continuous improvement to lower cost and increase production
Sites are complex with multiple automation systems (DCS, PLCs,
OEM etc.)
Requirement for Short Term Resources for capital/operational
automation projects i.e. Peak Resourcing is difficult
©2013 Zenith Technologies
Why have an outsourced model?
How can an outsourced model help
The 4 Key Discernible Benefits
Flexibility
Lower Cost
Cost
Greater Flexibility
Output
Increased Output
Improved Expertise
©2013 Zenith Technologies
Expertise
What is an outsourced model?
Dispelling the myths!
An outsourced model is really just a polite name for
Bodyshopping ?
An outsourced model gives control of automation and
validation to an outside vendor ?
©2013 Zenith Technologies
What is an outsourced model?
What is an Outsourced Model?
Is it an outsourcing your headcount? – No 
Is it outsourcing for a service? – Yes 
It’s a PARTNERSHIP rather than OUTSOURCING as we
know it – not a typical Client/Vendor relationship
i.e. The technology company provides a SERVICE to the
life science client
©2013 Zenith Technologies
What is an outsourced model?
A typical service an automation provider
would provide would be:
Automation
Systems
Network
Admin
24/7 On Call
Support
.
• Base workload requirement for
Sustaining Operations
Frontline
Automation
Support
• Supplemental support for small
Capital/Operational Projects
Automation
Systems
Validation
.
©2013 Zenith Technologies
Automation
Consultancy
Software
Change
Controls
Training
.
Automation
Project
Management
How to introduce an outsourced model
Resourcing
Operation
Design
Strategy
Continuous
Improvement
©2013 Zenith Technologies
How to introduce an outsourced model
Typical Automation/Validation Team Structure
Site Automation Lead
Site Quality/Validation
Lead
Staff Automation
Group
SME SUPPORT
Identification of issues/solutions for the Business Unit
Continuous Improvement/Strategy/Capital Projects
One engineer representing automation in each business unit
AUTOMATION (BU) SUPPORT
Execution of change controls, investigations and CAPAs for the Business Unit
Service Provider
VALIDATION SUPPORT
AUTOMATION (PLANT) SUPPORT
Front-line support from the production areas + 24/7 On-call support
PROJECT SUPPORT
Execution of small capital/operational projects
©2013 Zenith Technologies
Testing of change controls, creation of test
specifications etc. s for the Business Unit
How to introduce an outsourced model
Staff Engineers will be the client business representative for
automation in the business unit (production area)
 Service Provider will need one point of contact on site (Service Lead)
for the client – e.g. HR, Interface with client stakeholders and back
office support etc.
A service level agreement (SLA) will need to be in place with the
service provider to outline scope, metrics, deliverables etc.
©2013 Zenith Technologies
Questions
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