About EngiSystems software solutions

As the industry continues to utilize more and more software, our team of experts understand the importance of heavily weighing software validation into the overall business strategy. Our diverse team has the extensive knowledge about designing customized solutions that lower costs, improve quality, streamline processes and maintain compliance. Our vision is to be the global leaders in managed regulatory compliance and engineering solutions that enables Life Science manufacturers to bring safe, high-quality innovations to market quickly and profitably. Our client portfolio contains global leaders within the life science industry.

Synergistic Outcomes

Blended thought leadership with a dynamic execution team.

Checks and Balances

Accountable structure to mange the quality and productivity of the teams and compliance.

Strategic Team Development

Alignment of teams to meet business objectives.

Collaboration & Communication

Communication and integration of team members for optimized results.

Case Studies with Validated Results

CASE STUDY - REMEDIATION OF 700+ SOFTWARE SYSTEMS WITH REGULATORY IMPLICATIONS.

MEDICAL DEVICE COMPANY UNDER CONSENT DECREE

EngiSystems 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

EngiSystems 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)

EngiSystems 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.