Business & Decision Life Sciences specializes in reducing the cost of IS Compliance through the use of a lean IS compliance program, designed to help Life Sciences organizations reduce the cost of their IS compliance while maintaining sustainable levels of compliance and maintaining the validated state.
While many Life Sciences organizations approach IS compliance and validation at a tactical (project-by-project) level, Business & Decision Life Sciences understands that optimizing the cost of IS compliance requires a strategic approach. Business & Decision Life Sciences’ 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.
Business & Decision Life Sciences’ Lean IS compliance program consists of three stages:
Based upon key concepts contained in GAMP® 5 and benchmarked against Business & Decision Life Sciences’ 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.
When compared against simple cost saving programs designed to reduce the cost of IS compliance and validation in the short term, clients benefit from: