CASE STUDY - REMEDIATION OF 700+ SOFTWARE SYSTEMS WITH REGULATORY IMPLICATIONS.
MEDICAL DEVICE COMPANY UNDER CONSENT DECREE
EngiLifeSciences was contracted and utilized a risk prioritization approach to remediate ERP, various manufacturing, IT systems for a Medical Device Company under consent decree.
The challenge was to adapt quickly to the current company state, re-engineer the process, implement new process within the organization and baseline the software systems to a compliant state under very aggressive timelines.
The results of our engagement were that the company passed the system audit with the auditor commenting: "The [system] validation packages gets a grade A+."
CASE STUDY - GLOBAL IT OPTIMIZATION ASSESSMENT
SECOND LARGEST LIFE SCIENCE COMPANY
EngiLifeSciences was contracted to assess current policies, procedures, standards, tools and templates, while working with 27 teams to identify cost reduction Computer Systems Validation opportunities.
Our challenge was to identify and prioritize cost savings while maintaining compliance.
Our results were providing a roadmap that saved more than 25% of the overall CSV cost.
CASE STUDY - CSV AND INFRASTRUCTURE QUALIFICATION PROCESS
GLOBAL IT ORGANIZATION OF F500 ($100B IN SALES)
EngiLifeSciences was contracted to optimize and re-engineer a compliant CSV Program to include the quality systems policies and procedures for a Global IT Organization shared services.
Our challenge was to create compliant policies and procedures that aligned with business objectives and to fit the culture of the company to be optimized for cost savings while maintaining compliance.
Our results were a successful implementation with cost savings realized.