While many Life Sciences organizations approach IS Compliance and Validation at a tactical (project-by-project) level, Business & Decision understands that optimizing the cost of IS Compliance requires a strategic approach. Business & Decision's Lean IS Compliance Program is tailored to the specific needs of each client and is designed to deliver sustainable cost savings while assuring acceptable levels of regulatory compliance within the IS organization.

Lean IS Compliance Program

Business & Decision's Lean IS Compliance Program consists of three stages:

• Assessment,
• Strategy and roadmap development,
• Education and knowledge transfer.

Based upon key concepts contained in GAMP 5 and benchmarked against Business & Decision's unique IS Compliance Maturity Model (ISCMM), strategic objectives and scope are agreed at each stage in order to ensure appropriate return on investment.

Each stage of the program looks at the overall approach to IS Compliance including IT policies, processes and procedures, Computer Systems Validation, IT Infrastructure Qualification and the organizational change management issues associated with quality roles within the IS organization.

Sustainable Cost Savings

When compared against simple cost saving programs designed to reduce the cost of IS Compliance and Validation in the short term, clients benefit from:

• Sustainable cost savings, justified on the basis of risk to product quality and patient safety,
• Adoption of IT industry best practices, leveraging six-sigma and lean principles,
• Better alignment with outsourced service providers,
• Fulfillment of their responsibilities as a regulated company, in accordance with regulatory expectations,
• The ability to adjust to future technology, organizational and regulatory changes in a flexible and cost effective manner.

Top of page