Global Harmonisation of IT
and Validation Processes
Genni Sanders
Astellas Pharma EMEA
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Topics
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Introduction
A Journey not a Destination
Opportunities / Drivers
Challenges
The Journey
Achievements
Next Steps / Continuing the Journey
Conclusions
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Introduction
• Based on personal observations
– Includes experience with other companies
– Points not necessarily specific to any particular
organisation
• May be obvious for those of you in large
pharma companies
– You will have been through all this before and
have perfectly harmonised global processes
– But you may have forgotten how this was done
23 April 2015 – Astellas Pharma EMEA, Chertsey
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A Journey not a Destination
• Harmonisation is not a ‘one off’ exercise
– New opportunities arise
– Challenges are not static
• We can’t stop the business
– Have to continue supporting the business
whilst performing harmonisation
• We can’t do it all at once
– Has to be done in manageable steps
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Opportunities / Drivers
• A Growing Company
– As the company grows it is acting as a global
company
– We have tended to be regionally focussed
and relatively autonomous
• More Global Systems & Projects
– Increasing number of global and cross
regional systems needing global support
– Implementation projects can be global
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Opportunities / Drivers
• Regulatory Expectations
– Regulators expect consistent processes and
procedures
– Increasing global harmonisation of regulations
and inspections
• Company Culture of Collaboration
– Astellas has a culture of collaboration so
harmonisation is part of this
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Opportunities / Drivers
• Efficiency Improvements
– Not efficient to have ‘ad hoc’ harmonisation
eg at the beginning of projects
– Differences in approaches dealt with at
strategic level not repeatedly for each project
• Increased Flexibility
– Training is consistent
– Easier for personnel to work on global
projects
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Opportunities / Drivers
• Global IT Organisation
– IT is now globally organised
• Global IT Service Providers
– Recently established global arrangements
with Strategic IT Service Providers
– Previously regional and global arrangements
– Need consistent ways of working with them
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Challenges
• Growing Company
– Legacy Practices
– Smaller company culture
– Personnel not familiar with pharma industry
– It’s a good idea but ...
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Haven’t got time
Haven’t got the people
Why now?
Not more paperwork
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Challenges
• Organisational
– Although we are a global Japanese company we
have tended to operate as independent regional
entities
• Japan & Asia, Americas, EMEA
• Focus on regional business and regulations
• Own ways of working
– Not always aware of the regional differences
• EMEA has 21 affiliates with their own cultures,
languages and regulations
• In EMEA we tend to assume other regions are simpler
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Challenges
• Cultural
– Language (not always the obvious aspects)
– Meeting behaviours
• Geographical
– Time Zones for meetings
• Logistical
– Frequent face to face meetings not realistic
– Most people have ‘day jobs’
– Potentially many participants
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Challenges
• Technical Knowledge
– Different Disciplines
– Business, Analysts, Developers, Project Managers, Consultants
– Differing levels of technical understanding
– Varying experience of system implementation
• Compliance Knowledge
– Variable across functions, departments
– Varying degrees of being up to date
• ‘Old School’ or Risk Based Validation
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Challenges
• Different Ways of Working
– ‘Dev’ is a Sandbox and formal testing only
performed in ‘Test’
– ‘Dev’ is a controlled environment with formal
testing here and in ‘Test’
– Testing in Production allowed or not allowed
• Different Interpretations of Regulations
– R & D, Manufacturing, Supply Chain
– Regional interpretations of underlying principles
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Challenges
• Why should we change?
– Not ‘Invented Here’
– Optimised specific processes or more generic
– What’s wrong with our current processes
• Underestimating the effort & time
– Aren’t we already harmonised?
• We have global Policies and Standards
• Anyway we follow GAMP, don’t we?
– Company Culture – Collaboration
• Consensus can take a long time to achieve
23 April 2015 – Astellas Pharma EMEA, Chertsey
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The Journey
• Cultural Aspects
– Company philosophy helped us to overcome language and
behavioural challenges
• Geography & Logistics
• Face to Face Meetings / Workshops
– Content creation and confirming understanding
– Rotated locations – Tokyo, Chicago, Hillswood
• Webex meetings for reviews, status updates
– Compromise – early US / late Japan / midday UK (rotated)
• Core Team & Sub Teams
– Key representatives as POCs for wider stakeholders
– Specialist sub teams for specific topics
23 April 2015 – Astellas Pharma EMEA, Chertsey
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The Journey
• What is harmonisation?
– Achieving a common understanding
– Not ‘imposing’ one region’s processes on all
– Not necessarily what we do now
– Not the lowest common denominator
– Step back and see what we need to do
– Pick the best practices in the company
– Look at what other companies have done
23 April 2015 – Astellas Pharma EMEA, Chertsey
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The Journey
• Level of harmonisation?
– SOPs, Work Instructions, Templates?
– Already have global policies and standards
– Some functions, eg R&D, harmonised for US / EU
• Scope
– Business Systems only?
– Manufacturing & Laboratory Systems?
• Initially focus on business systems
• Additional controls for other systems if adopting
23 April 2015 – Astellas Pharma EMEA, Chertsey
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The Journey
• Implementation Approach
– Definition is not the same as Implementation
– ‘Big bang’ or phased approach?
• Transition Plans for each function
– Gap and impact assessments for current
processes and projects
– When to adopt
– How to adopt
• Current materials – update or retire
• New materials – need to create?
23 April 2015 – Astellas Pharma EMEA, Chertsey
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The Journey
• Divided by a Common Language
– Implementation
• Performing the Change or Deploying into Production
– Validation
• “Process to achieve fitness for intended use” or Testing
– Lessons
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Establish Glossary and agree meanings
Try to be pro active and anticipate obvious words
Don’t assume everyone has the same understanding
Expect the unexpected
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Achievements
• Defined global SDLC and CSV processes
– Apply to regulated and non regulated systems
– Global procedures and templates approved
• Governance & ownership established
– Ongoing responsibilities defined
– Updates and responding to feedback
• Regional implementations in various stages
of planning and execution
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Next Steps /
Continuing the Journey
• Adoption & ‘Bedding In’
– Implementations could take 6 to 12 months
for most functions. Some may need longer.
• Responding to Feedback
– Collation and analysis
– Agreement on updates
• Next Steps
– Identification of further opportunities
– Monitoring Usage
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Next Steps /
Continuing the Journey
• A Single Process does not Guarantee
Consistency
– Change Management Example
• Same process across functions and projects
– Detailed SOP ~ 40 pages
– Detailed Guidance ~ 60 pages
• Analysis Showed Significantly Inconsistent Executions
– Information captured in Change Records had varying detail
– Deliverables to support similar changes varied significantly
– Testing not performed consistently
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Next Steps /
Continuing the Journey
• A Single System does not Guarantee
Consistency
– LIMS Example - Tablet Dissolution
• Same Product Specification / Test / LIMS
• Different LIMS implementation for each site
– Tablet Dissolves within 30s – Result is Pass / Fail
– Time to Dissolve – Result is recorded time which is compared
to limit of 30s to determine Pass / Fail
• C of A generated at different site from site of test
– Problem if need to report time on C of A if the testing site has
the binary test
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Conclusions
• Generally a worthwhile investment of time
and effort
• Good foundation for moving forward
• Different to experience in other companies
– More consensus not imposition
– Although frustrating at times, feels that more
has been achieved
– Use feedback to shape next phases
23 April 2015 – Astellas Pharma EMEA, Chertsey
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Questions
23 April 2015 – Astellas Pharma EMEA, Chertsey
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