Quality Management

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Business & Decision Life Sciences supports Life Sciences organizations in aligning their IT processes with the needs of the business and in assuring compliance with regulatory expectations.

IT groups within Life Sciences organizations face seemingly impossible challenges to align with business needs, improve service levels and reduce costs while at the same time meeting the regulatory expectations of GxP and financial auditors.

IT Process Compliance in Life Sciences

Business & Decision Life Sciences has developed significant experience supporting clients in meeting regulatory expectations through the use of efficient and compliant IT processes while also meeting multiple business demands. This has included the development of one-off processes to support specific systems or platforms through to the development of integrated quality management systems.

Leveraging GAMP 5® key concepts and using validation library accelerators and templates, Business & Decision Life Sciences’ consultants work with clients to develop a streamlined and compliant IT quality management system with an appropriate QA oversight role.

Leveraging IT Good Practice (ITIL, COBIT, ISO)

While industry standards such as ISO, ITIL and COBIT are not designed to meet the specific regulatory needs of the Life Sciences industry, they provide a strong platform on which to build and facilitate the outsourcing of services through the use of common process models.

Business & Decision Life Sciences has developed a comprehensive model used to assess the state of IT compliance, identify and close any gaps through the use of IT industry standard processes. This includes the necessary checklists, tools and training needed to meet the specific needs of the Life Sciences industry.

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