1. “IT Regulatory Compliance - Business Benefit or a Burden?”
David Thompson
Principal Consultant
Clarity Compliance Solutions Ltd
Your Gateway to Compliance
single source  cost-effective  pragmatic solutions

2. Background Computer Systems Validation and Compliance
IT / Computer Systems arena for almost 30 years
19 years Consultancy, Auditing and Training
Pharmaceutical, Biotech, Research and Development, UK, Europe, Asia and the U.S.A.
Member of the GAMP MES and Data Integrity SIGs
Author on GAMP Good Practice Guide - “Data Integrity through the Data Life Cycle” (TBC) due Q

3. Cost of Compliance Benefit or Burden Right System High on-stream time
Typical IT System Validation Costs
10% - 20% of project cost
Benefit or Burden
Project Cost
Validation cost
£100,000
£20,000
£500,000
£100,00
£1,000,000
£200,000
Right System
High on-stream time
High automation
Easy operation
Only for regulators
Restrictive change
Awkward operation
High cost

4. Organisational perspective
Benefit
Organisation Behavioural Culture
Burden
Structured Methodologies

5. Leading Quality Indicators & Triggers
Positive Quality Culture
Leadership and Vision
Foster and Develop
Improve and Learn
Monitor and Measure
Corporate Culture
Leading Quality Indicators & Triggers
Mindset and Attitudes
Cultural Enablers
Gemba
Walk
Oversight and
reporting

6. The Hearts and Minds of Quality
Positive Quality Culture
Organisational Culture
Remove the Pressure
Management Led
DI Assessments
Remove the opportunity
DI Program
Behavioural Culture
Remove the Justification
The Hearts and Minds of Quality

7. Structured Methodologies
Robust IT Project Development Lifecycle
Phased Stage Gate Controlled
Rigorously controlled
Scoping and Stage Gate 1 critical to
Identifying Business Objectives & Goals
Senior Stakeholder (budget owners) buy-in
Successful project

8. Example – EDMS project Small company c80 staff
Paper based Quality System
Compliance issue - many paperwork errors = CAPA’s
Investigated EDMS, bought EQMS

9. Example – EQMS project Massive business benefit Cost effective
5 mins/day
Training
Equipment
Calibration
Org & Behaviour Culture
Improving
Structured Methodologies
Developing
Compliance being seen as a benefit

10. Example – Global CRM project
Global Organisation – Very well known in UK
Sales force automation globally (i-pads vs notebooks)
Project Charter Goals
Global Sales – daily reporting
Reduce incorrect orders
Reduce stock destruction
Core Systems build
Phase 1 – 15 countries deployment in 9 months
Phase 2 – 27 countries deployment in 9 months
My role - Global Program Quality Manager

11. Best Feedback - Field Sales Rep
Example – Global CRM project
Using Compliance for effectiveness
Rigorous training and access control
Rigorous Stage Gate development lifecycle
Adapted Agile approach
No wet ink signatures – all EDMS
Validation – E-Test Tool
Program – Great Success
Delivered Charter Goals
Massive savings
Minimal post go-live issues
Best Feedback - Field Sales Rep
“I’ve got my life back”

12. Summary Burden or benefit?
Big challenge within organisations
Changing the mind-set very important
On boarding of senior manager essential
Improve the Quality Culture
Provide the tools, techniques and systems
Design projects for success, not failure
Deliver with rigour
We will see a shift to “Compliance is a benefit”
GSOP 4 – Process based approach

13. Your Compliance Partner a One Stop Shop for your compliance needs
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