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Validation - Walk the Talk

Someone once said "The gap between expectation and reality is called disappointment" - well few businesses can afford to disappoint regulatory requirements these days. However meeting global regulatory expectations is easier said than done. They are no longer happy to accept the business' restricted and limited procedures and practices. 'If it is not documented, it never happened', is the mantra, and for savvy business stakeholders it had better be transparent and well documented too!

So now we have you thinking about your own validation process and how it measures up. Do any of the following examples sound familiar?


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By Bash Hemani, Managing Director at C4Consulting and Stig Werner, Senior Validation Manager for Europe Pharma Companies

Bash Hemani specialises in the understanding and implementation of computer system validation to MHRA and FDA regulatory requirements and information system auditing. He also specialises in management of change, exploiting large IT projects to engineer radical business process improvements with emphasis on supply chain alignment, and IT re-alignment. He is a member of the ISPE GAMP forum. Bash studied Production Engineering at Leeds University and gained an MBA in Production Management from Bradford University. Bash is currently Managing Director of C4Consulting.


Stig Werner is a Senior Validation Manager for Europe with one of the larger, generic global pharma companies. He has a broad professional background, spanning from Certified System Information Systems Auditor in one of the big five auditing companies, to Director of IT in a global API pharma company. He is a Bachelor of Management from the Norwegian School of Management BI, Oslo, where he specialised in project management.


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Bash Hemani
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Stig Werner
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