IS Compliance & Validation

Lean is the buzz word of the day, but what does it mean in terms of IS compliance and computer system validation? Can businesses really trim validation 'waste', improve quality and reduce the cost of IS processes while still remaining compliant? How should Life Sciences organizations best leverage the Global Delivery Model of leading consultancies and assure compliance and reduce costs. Business & Decision helps clients of all sizes utilize key performance indicators to achieve a sustainable state of 'least cost compliance'.

Solutions and Services

Business & Decision delivers industry leading IS Compliance and Computer System Validation services that are designed to help reduce the overall cost of compliance in Life Sciences organizations.

Located globally in Europe, North America & Asia and with international knowledge and expertise, Business & Decision offers clients a comprehensive service including industry thought-leadership and a range of strategic solutions and tactical services that provide cost-effective and comprehensive IS compliance and validation.

For clients looking for strategic and sustainable changes in their approach to IS Compliance and Computer System Validation (CSV), Business & Decision's team of highly-qualified consultants can deliver a broad suite of strategic consulting services in the areas of computer systems validation, infrastructure qualification, IT Quality Management and IS process improvement. This allows clients to strategically address IS Compliance and CSV issues, reduce costs without risking regulatory non-compliance and leverage leading edge beneficial technologies such as virtualization, cloud computing and Service Oriented Architecture.

For clients looking for cost effective project support Business & Decision also provides a range of tactical services capable of supporting key projects and maintaining control and compliance through the life of computer systems and associated infrastructure. This leverages twenty years of industry leading experience and a scalable and flexible resourcing model to minimize the scope of IS compliance and validation on the basis of risk-mitigation and deliver cost effective services across projects and geographies.

Global Delivery Model for Validation and Compliance

Business & Decision leverages its RightDelivery® Global Delivery Model to ensure that the right blend of resources (different consulting grades, on-site, off-site and remote) is used to provide industry leading yet competitive services. These are designed to support our clients through:

• Short term strategic consulting engagements

• Longer term fixed price projects

• The operational phase via service level agreements

This allows Business & Decision to leverage its position as industry thought leaders, its knowledge of international regulations, regulatory and industry guidelines, and global resources to deliver services of unique value to local and international clients. In order to appropriately scope validation and other project activities, all projects have on-going access to Senior and Principal Consultants at key stages in a project (planning, key milestone reviews, reporting and to help address significant risks and issues). It is this strategic input which acheives the right balance between compliance, risk mitigation and cost reduction. Staffed by an appropriate mix of resources for on-going project and operational phase support (on-site and off-site, on-shore or off-shore), Business & Decision's RightDelivery® Global Delivery Model for IS Compliance and Validation provides the optimum solution for acheiving sustainable Least Cost of Compliance.

Most importantly, what differentiates Business & Decision is its ability to work with clients, to consider the long-term implications of IS Compliance and Computer Systems Validation and to develop a tailored service which ensures both compliance with regulatory expectations and significant and sustainable cost savings in the medium to long term.

View our Webcasts

Click here to view our wide range of IS Compliance and Validation Webcasts