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Auditors’ questions

Auditors’ questions

If you’re an auditor and you’ve reached this page, it’s probably because your regulatory or pharmacovigilance colleagues have decided they want to purchase our software and you want to check us out as a potential supplier. This page aims to answer the questions you might have, alternatively we would be happy to complete your vendor questionnaire.

What certifications do you have?

Samarind is dedicated to achieving operational excellence as guaranteed by our ISO 9001:2008 certified quality management system.

Do you have a Quality Management System?

Yes, we have a comprehensive quality management system. Samarind is committed to the very highest quality standards and recognises the need for industry compliance. We work tirelessly with our clients to provide assurances that our quality management system is effectively an extension of their own.

What development methodologies do you use?

Samarind software development embraces an agile process for rapid adaptation to the constantly changing demands and requirements of the life sciences industry. Our software development and validation is undertaken according to GAMP 5 best practices. A comprehensive risk-based approach is taken to ensure regulatory compliance.

Our validation activities occur throughout the entire software development life cycle, this ensures that all requirements have been fulfilled and that the software reaches the highest standards of quality we expect here at Samarind.

Samarind Limited has taken appropriate measures to ensure that all versions of our ‘Samarind RMS for Windows®’ Regulatory Management Software facilitate 21 CFR Part 11 compliance.

Can we come and audit you?

Yes of course, in fact we welcome customer audits. Our Quality & Compliance Manager, Phil Geens, will be glad to host your visit and provide any information you require.

I have more questions ...

If you have any more questions please don’t hesitate to contact us.

For more information please get in touch using the details on our contact form.

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