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CONTACT OUR REGIONAL COMPLIANCE AND VALIDATION CENTERS

In order to support local and international clients, Business & Decision's Compliance and Validation teams are based in two regional centers:

Life Sciences Home > Services & Solutions > IS Compliance and Validation

Computer System Validation & IS Compliance

Business & Decision's consultants are internationally recognized as IT Compliance and Computer System Validation thought leaders and as significant contributors to both regulatory and industry guidance.

Computer Systems Validation

Computer Systems Validation is about more than just complying with regulatory expectations. Successful validation requires an appropriate life cycle, effective program and project management and a thorough understanding of both the business processes being supported and the associated regulations (GLP, GCP, GMP and GDP).

Business & Decision specialise in the validation of mission critical enterprise applications, many of which are also implemented by the companies System Integration teams (e.g. eClinical, ERP, CRM, Safety and Quality systems). Risk-based validation has been used for more than ten years and Business & Decision is now successfully applying the principles GAMP® 5 as well as ‘lean' and six-sigma principles to reduce validation costs and assure least-cost compliance.

IS Compliance

Business & Decision believes that IS Compliance is built on good IT practice. Numerous clients have successfully improved the efficiency of their IT operations and qualified their IT infrastructure.

This is achieved by leveraging Business & Decision's unique combination of IT consulting and regulatory expertise, by building on IT industry standards such as ITIL and COBIT and embedding controls to support regulatory compliance.